Biosimilars/News

Tanvex BioPharma submits filgrastim biosimilar to Health Canada

Biosimilars/News | Posted 01/02/2019

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) announced on 16 January 2019 that it had submitted a biosimilar application to Health Canada for its proposed filgrastim biosimilar TX01.

FDA approves trastuzumab biosimilar Herzuma

Biosimilars/News | Posted 01/02/2019

On 14 December 2018, the US Food and Drug Administration (FDA) approved the trastuzumab biosimilar, Herzuma (trastuzumab-pkrb), for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer.

FDA approves trastuzumab biosimilar Ontruzant

Biosimilars/News | Posted 25/01/2019

On 18 January 2019, the US Food and Drug Administration (FDA) approved the trastuzumab biosimilar, Ontruzant (trastuzumab-dttb), for the treatment of patients with breast and gastric cancer.

CKD Pharma’s darbepoetin alfa biosimilar launched in Japan

Biosimilars/News | Posted 18/01/2019

On 4 December 2018, South Korean drugmaker Chong Kun Dang Pharmaceutical (CKD Pharma) announced that it had received approval for its second-generation anaemia biosimilar, CKD‑11101 (darbepoetin alfa).

EMA approval for bevacizumab biosimilar Zirabev

Biosimilars/News | Posted 11/01/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 13 December 2018 that it had recommended granting marketing authorization for the bevacizumab biosimilar Zirabev.

Trastuzumab and agalsidase beta biosimilars launched in Japan

Biosimilars/News | Posted 11/01/2019

Japanese firms have announced the launch of trastuzumab and agalsidase beta biosimilars in Japan on 28 November 2018.

Biosimilars launched in the US at a significant discount

Biosimilars/News | Posted 14/12/2018

Epoetin alfa and pegfilgrastim biosimilars have been launched in the US at a significant discount compared to their originators.

FDA approves first rituximab biosimilar Truxima

Biosimilars/News | Posted 07/12/2018

On 28 November 2018, the US Food and Drug Administration (FDA) approved its first rituximab biosimilar, Truxima (rituximab-abbs), the first biosimilar for the treatment non-Hodgkin’s lymphoma (NHL).

EC approval for pegfilgrastim biosimilars Pelmeg and Ziextenzo

Biosimilars/News | Posted 30/11/2018

In November 2018, pegfilgrastim biosimilars, Pelmeg and Ziextenzo, received European Commission (EC) approval.

Tanvex BioPharma submits filgrastim biosimilar to FDA

Biosimilars/News | Posted 23/11/2018

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) announced on 1 October 2018 that it had submitted its first biosimilar application to the US Food and Drug Administration (FDA). The application is for its proposed filgrastim biosimilar TX01.

Insulin glargine biosimilars launched in UK and South Korea

Biosimilars/News | Posted 23/11/2018

November 2018 has seen the launch of insulin glargine biosimilars in both the UK and South Korea.

Another adalimumab copy biological accepted for review in China

Biosimilars/News | Posted 16/11/2018

The China National Drug Administration (CNDA), formerly the China Food and Drug Administration (CFDA) has accepted another application for approval of an adalimumab copy biological, this time from Innovent Biologics (Innovent).

FDA approves adalimumab and pegfilgrastim biosimilars

Biosimilars/News | Posted 09/11/2018

The US Food and Drug Administration (FDA) announced on 30 October 2018 and on 2 November 2018 that it had approved adalimumab and pegfilgrastim biosimilars, respectively.

Adalimumab biosimilars Amgevita and Imraldi launched in Europe

Biosimilars/News | Posted 02/11/2018

In October 2018, two adalimumab biosimilars have been launched in the European Union (EU). Amgen announced the European launch of its adalimumab biosimilar, Amgevita and Biogen announced the launch of its adalimumab biosimilar Imraldi.

Trastuzumab similar biologic Hervycta launched in India

Biosimilars/News | Posted 02/11/2018

India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 26 July 2018 the launch of its product Hervycta, a ‘similar biologic’ of trastuzumab, in India.

Mylan gains nod for Ogivri and launches Hulio in Europe

Biosimilars/News | Posted 26/10/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced at its meeting on 18 October 2018 that it had recommended granting marketing authorization for the trastuzumab biosimilar Ogivri.

FDA reviews adalimumab biosimilar SB5

Biosimilars/News | Posted 26/10/2018

Samsung Bioepis announced on 27 September 2018 that the regulatory submission for its proposed adalimumab biosimilar (SB5) had been accepted by the US Food and Drug Administration (FDA).

Two darbepoetin alfa biosimilars submitted to Japan’s PMDA

Biosimilars/News | Posted 12/10/2018

Two South Korean firms have announced that they have submitted applications for approval of their proposed darbepoetin alfa biosmilars to Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA).

EC approval for adalimumab and pegfilgrastim biosimilars Hulio and Udenyca

Biosimilars/News | Posted 05/10/2018

In September 2018, adalimumab biosimilar, Hulio, and pegfilgrastim biosimilar, Udenyca, received European Commission (EC) approval.

EMA approves pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo

Biosimilars/News | Posted 28/09/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 21 September 2018 that it had recommended granting of marketing authorizations for the pegfilgrastim biosimilars Fulphila, Pelmeg and Ziextenzo.

Adalimumab copy biologicals accepted for review in China

Biosimilars/News | Posted 28/09/2018

China Food and Drug Administration (CFDA) has accepted applications for approval of adalimumab copy biologicals from Hisun Pharma (Hisun) and Bio‑Thera Solutions (Bio‑Thera).

FDA advisers recommend approval of rituximab biosimilar CT-P10

Biosimilars/News | Posted 19/10/2018

US Food and Drug Administration (FDA) advisers have voted unanimously to recommended approval for CT‑P10, a biosimilar version of Roche’s MabThera/Rituxan (rituximab). If approved by FDA, this would be the first rituximab biosimilar approved in the US.

Adalimumab and trastuzumab biosimilars gain EC approval

Biosimilars/News | Posted 21/09/2018

A trastuzumab biosimilar from Pfizer and three adalimumab biosimilars from Sandoz have been approved by the European Commission (EC).

Japan approves first darbepoetin alfa biosimilar

Biosimilars/News | Posted 14/09/2018

Japan-based Kyowa Hakko Kirin announced on 16 August 2018 that it had gained Japanese approval for its darbepoetin alfa biosimilar.

Trastuzumab and Bevacizumab products approved in Australia and Argentina

Biosimilars/News | Posted 07/09/2018

Australia has approved a trastuzumab biosimilar and Argentina has approved a bevacizumab medicamento biológico similar.

EMA approves adalimumab and pegfilgrastim biosimilars

Biosimilars/News | Posted 31/08/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 July 2018 that it had recommended granting marketing authorization for the adalimumab biosimilar Hulio and also for the pegfilgrastim biosimilars Pelgraz and Udenyca.

FDA approves filgrastim biosimilar Nivestym

Biosimilars/News | Posted 24/08/2018

On 20 July 2018, the US Food and Drug Administration (FDA) approved its second filgrastim biosimilar. The filgrastim biosimilar, Nivestym (filgrastim-aafi), is produced by US pharma giant Pfizer.

Rituximab biosimilar submitted to EMA and Rituxan gains extra indication

Biosimilars/News | Posted 20/07/2018

Poland-based Mabion announced on 1 June 2018 that its candidate rituximab biosimilar (MabionCD20) had been accepted for regulatory review by the European Medicines Agency (EMA).

Pfizer gains Japanese approval for infliximab biosimilar

Biosimilars/News | Posted 13/07/2018

Pfizer Japan announced on 2 July 2018 that it had gained Japanese approval for its infliximab biosimilar.

FDA rejects botulinum toxin biosimilar from Evolus

Biosimilars/News | Posted 06/07/2018

US-based Evolus announced on 16 May 2018 that the US Food and Drug Administration (FDA) had rejected its application for approval of DWP‑450 (prabotulinumtoxinA).

FDA rejects Amgen’s trastuzumab biosimilar

Biosimilars/News | Posted 29/06/2018

Biotech giant Amgen announced on 4 June 2018 that the US Food and Drug Administration (FDA) had rejected the application for approval of its trastuzumab biosimilar.

Celltrion resubmits biosimilar trastuzumab to FDA

Biosimilars/News | Posted 22/06/2018

South Korean biotechnology company Celltrion announced on 18 June 2018 that it had resubmitted its application for marketing approval for its candidate trastuzumab biosimilar, CT‑P6, to the US Food and Drug Administration (FDA).

Etanercept biosimilars submitted to EMA and launched in Japan

Biosimilars/News | Posted 15/06/2018

An etanercept biosimilar has been submitted to the authorities in Europe and Japan, and another etanercept biosimilar has been launched in Japan.

EMA approves adalimumab and trastuzumab biosimilars

Biosimilars/News | Posted 08/06/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 1 June 2018 that it had recommended granting marketing authorization for the adalimumab biosimilars Halimatoz, Hefiya and Hyrimoz, and also for the trastuzumab biosimilar Trazimera.

FDA approval for pegfilgrastim biosimilar Fulphila

Biosimilars/News | Posted 08/06/2018

The US Food and Drug Administration (FDA) announced on 4 June 2018 that it had approved its first pegfilgrastim biosimilar.

Celltrion resubmits biosimilar rituximab to FDA

Biosimilars/News | Posted 01/06/2018

South Korean biotechnology company Celltrion announced on 30 May 2018 that it had resubmitted its application for marketing approval for its candidate rituximab biosimilar, CT‑P10, to the US Food and Drug Administration (FDA).

EC approval for infliximab biosimilar Zessly

Biosimilars/News | Posted 25/05/2018

Sandoz, the generics division of Novartis, announced on 24 May 2018 that it had received European Commission (EC) approval for its infliximab biosimilar Zessly (PF‑06438179).

Hetero launches adalimumab similar biologic in India

Biosimilars/News | Posted 25/05/2018

India-based generics maker Hetero Group (Hetero) announced in January 2018 the launch of its product Mabura, a ‘similar biologic’ of adalimumab, in India.

Pegfilgrastim biosimilar Lapelga approved in Canada

Biosimilars/News | Posted 18/05/2018

Canada-based Apotex received approval for its pegfilgrastim biosimilar, Lapelga, from Health Canada with positive decision made on 5 April 2018. This marks the first pegfilgrastim biosimilar to be approved by the Canadian medicines regulator.

FDA approves epoetin alfa biosimilar Retacrit

Biosimilars/News | Posted 18/05/2018

The US Food and Drug Administration (FDA) approved its first epoetin alfa biosimilar on 15 May 2018.

Biosimilar etanercept Eucept approved in South Korea

Biosimilars/News | Posted 11/05/2018

South Korea-based LG Chem has obtained regulatory approval to begin marketing and selling its etanercept biosimilar in Korea.

FDA rejects trastuzumab and rituximab biosimilars

Biosimilars/News | Posted 04/05/2018

US pharma giant Pfizer announced on 23 April 2018 that the US Food and Drug Administration (FDA) had rejected its application for approval of its trastuzumab biosimilar. Then Sandoz, part of Novartis, announced on 2 May 2018 that its biosimilar rituximab application had also been rejected.

Australia approves rituximab biosimilar Truxima

Biosimilars/News | Posted 27/04/2018

South Korean biotechnology company Celltrion announced on 23 April 2018 that Australia’s regulatory body, the Therapeutic Goods Administration (TGA), has approved its rituximab biosimilar, Truxima (CT‑P10).

FDA rejects Celltrion/Teva’s rituximab and trastuzumab biosimilars

Biosimilars/News | Posted 20/04/2018

South Korean biotechnology company Celltrion announced on 6 April 2018 that it had received complete response letters (CRLs) from the US Food and Drug Administration (FDA) regarding its candidate rituximab (CT‑P10) and trastuzumab (CT‑P6) biosimilars.

EMA approval for infliximab biosimilar Zessly

Biosimilars/News | Posted 13/04/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 March 2018 that it had recommended granting marketing authorization for the infliximab biosimilar Zessly.

EMA approval for trastuzumab biosimilar Kanjinti

Biosimilars/News | Posted 06/04/2018

Insulin biosimilar Semglee gains EC and Australian approval

Biosimilars/News | Posted 30/03/2018

India-based Biocon and US-based partner Mylan announced on 28 March 2018 that they had received European Commission (EC) and Australian approval for their co-developed insulin glargine biosimilar, Semglee.

Trastuzumab biosimilar Ontruzant launched in the UK

Biosimilars/News | Posted 23/03/2018

Merck Sharp and Dohme (MSD), which is known as Merck in the US and Canada, announced on 8 March 2018 that it had launched the trastuzumab biosimilar, Ontruzant, in the UK.

Insulin glargine biosimilar gains South Korean approval

Biosimilars/News | Posted 16/03/2018

South Korea-based GC Pharma (formerly Green Cross Corporation) announced on 8 March 2018 that it had received approval for its insulin glargine biosimilar Glarzia from the Korean Ministry of Food and Drug Safety (MFDS).

Trastuzumab biosimilar launched in South Korea

Biosimilars/News | Posted 09/03/2018

South Korean pharmaceutical company Daewoong Pharmaceutical announced on 5 March 2018 that it had launched trastuzumab biosimilar Samfenet, developed by Samsung Bioepis, in South Korea.

EC approval for trastuzumab biosimilar Herzuma

Biosimilars/News | Posted 02/03/2018

South Korean biotechnology company Celltrion announced on 14 February 2018 that it had received European Commission (EC) approval for its biosimilar trastuzumab product Herzuma (CT‑P6).

EMA approval for biosimilar insulin glargine Semglee

Biosimilars/News | Posted 15/02/2018

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 25 January 2018 that it had recommended granting marketing authorization for the insulin glargine biosimilar Semglee.

Denosumab biosimilar being developed in Australia

Biosimilars/News | Posted 09/02/2018

Australian biologicals company NeuClone disclosed on 5 January 2018 the fifth biosimilar candidate that the company is developing in its pipeline of monoclonal antibody (mAb) products. The product is a biosimilar candidate for denosumab and is currently in preclinical development.

EC approval for bevacizumab biosimilar Mvasi

Biosimilars/News | Posted 02/02/2018

Biotech giant Amgen announced on 18 January 2018 that it had received European Commission (EC) approval for its biosimilar bevacizumab product Mvasi (ABP 215).

FDA accepts applications for adalimumab and trastuzumab biosimilars

Biosimilars/News | Posted 02/02/2018

Samsung Bioepis and Sandoz announced on 20 December 2017 and 16 January 2018, respectively, that the regulatory submissions for their proposed trastuzumab (SB3) and adalimumab (GP2017) biosimilars had been accepted by the US Food and Drug Administration (FDA).

EMA accepts application for pegfilgrastim biosimilar from USV

Biosimilars/News | Posted 26/01/2018

India-based biologicals specialist USV Biologics (USV) announced on 7 December 2017 that the application for approval for its proposed pegfilgrastim biosimilar has been accepted by the European Medicines Agency (EMA).

Trastuzumab biosimilars receive EMA and ANVISA approval

Biosimilars/News | Posted 26/01/2018

Trastuzumab products from Celltrion Healthcare (Celltrion) and Biocon/Mylan have received approval in Europe and Brazil.

FDA approves follow-on insulin lispro Admelog

Biosimilars/News | Posted 19/01/2018

Pharma giant Sanofi announced on 11 December 2017 that the US Food and Drug Administration (FDA) had approved its follow-on version of Eli Lilly’s Humalog (insulin lispro).

FDA approves biosimilar infliximab Ixifi

Biosimilars/News | Posted 12/01/2018

Pfizer announced on 13 December 2017 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Johnson & Johnson and Merck’s Regicide (infliximab).

Humira deal could cost CMS US$1.48 billion

Biosimilars/News | Posted 10/11/2017

The settlement deal made between US-based biotech giant Amgen and pharma giant AbbVie regarding AbbVie’s blockbuster arthritis drug Humira (adalimumab) could cost the US Centers for Medicare and Medicaid Services (CMS) at least US$1.48 billion.

Amgen’s adalimumab biosimilar will only be launched in US in 2023

Biosimilars/News | Posted 20/10/2017

US-based biotech giant Amgen and pharma giant AbbVie announced on 28 September 2017 that they had reached a ‘global resolution’ ending all patent litigation regarding AbbVie’s blockbuster arthritis drug Humira (adalimumab).

Bevacizumab similar biologic launched in India

Biosimilars/News | Posted 12/01/2018

India-based biologicals specialist Biocon announced on 23 November 2017 the launch of its product Krabeva, a ‘similar biologic’ of bevacizumab, in India.

FDA approves trastuzumab biosimilar Ogivri

Biosimilars/News | Posted 05/01/2018

On 1 December 2017, the US Food and Drug Administration (FDA) approved its first trastuzumab biosimilar.

EMA accepts applications for pegfilgrastim and trastuzumab biosimilars from Biocon/Mylan

Biosimilars/News | Posted 08/12/2017

India-based biologicals specialist Biocon and US-based partner Mylan announced on 1 December 2017 that the applications for approval for their proposed pegfilgrastim (MYL‑1401H) and trastuzumab (MYL‑1401O) biosimilars have been accepted by the European Medicines Agency (EMA).

EC approval for trastuzumab biosimilar Ontruzant

Biosimilars/News | Posted 01/12/2017

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 20 November 2017 that it had received European Commission (EC) approval for its biosimilar trastuzumab product Ontruzant (SB3).

South Africa approves first non-originator biological

Biosimilars/News | Posted 01/12/2017

South Africa’s Medicines Control Council (MCC) has approved the country’s first non-originator biological, filgrastim, from Teva Pharmaceutical Industries (Teva).

EMA approval for bevacizumab biosimilar Mvasi

Biosimilars/News | Posted 24/11/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 10 November 2017 that it had recommended granting marketing authorization for the bevacizumab biosimilar Mvasi.

EC approval for adalimumab biosimilar Cyltezo

Biosimilars/News | Posted 17/11/2017

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer) announced on 13 November 2017 that it had received European Commission (EC) approval for its biosimilar adalimumab product Cyltezo (BI 695501).

Adalimumab and trastuzumab biosimilars approved in South Korea

Biosimilars/News | Posted 17/11/2017

South Korean biosimilars maker Samsung Bioepis announced on 9 November 2017 that it had received marketing approval for its biosimilar version of Roche’s blockbuster breast cancer therapy Herceptin (trastuzumab) from Korea’s Ministry of Food and Drug Safety (MFDS). The news follows another announcement by the company on 22 September 2017 that it had also gained approval for its adalimumab biosimilar (SB5).

EMA accepts biosimilar pegfilgrastim application from Sandoz

Biosimilars/News | Posted 03/11/2017

Sandoz, the generics division of Novartis, announced on 27 October 2017 that the regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the European Medicines Agency (EMA).

Novo Nordisk petitions FDA to require clinical trials for Victoza biosimilars

Biosimilars/News | Posted 27/10/2017

Danish pharmaceutical company Novo Nordisk has asked the US Food and Drug Administration (FDA) to require clinical trials for biosimilar applications for its blockbuster diabetes drug Victoza (liraglutide).

FDA delays approval of Biocon/Mylan’s pegfilgrastim biosimilar

Biosimilars/News | Posted 20/10/2017

India-based biologicals specialist Biocon announced on 10 October 2017 that it has been informed by the US Food and Drug Administration (FDA) that its pegfilgrastim biosimilar, which it is developing jointly with Mylan, cannot be approved at present.

EMA accepts application for pegfilgrastim biosimilar from Cinfa

Biosimilars/News | Posted 13/10/2017

Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 4 October 2017 that its application for approval for its proposed pegfilgrastim biosimilar (B12019) had been accepted by the European Medicines Agency (EMA).

Nichi-Iko gains Japanese approval for infliximab biosimilar

Biosimilars/News | Posted 13/10/2017

Japan-based generics maker Nichi-Iko Pharmaceutical (Nichi-Iko) announced on 27 September 2017 that it had gained Japanese approval for its infliximab biosimilar.

JCR files for Japanese approval of agalsidase beta biosimilar

Biosimilars/News | Posted 06/10/2017

Japan-based JCR Pharmaceuticals (JCR) announced on 29 September 2017 that it had applied for Japanese regulatory approval for its agalsidase beta biosimilar (JR‑051).

FDA accepts application for Adello’s filgrastim biosimilar

Biosimilars/News | Posted 06/10/2017

US-based biosimilars specialist Adello Biologics (Adello) announced on 11 September 2017 that the regulatory submission for its proposed filgrastim biosimilar had been accepted by the US Food and Drug Administration (FDA).

EMA approval for adalimumab and trastuzumab biosimilars

Biosimilars/News | Posted 29/09/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 September 2017 that it had recommended granting marketing authorization for the adalimumab biosimilar Cyltezo and the trastuzumab biosimilar Ontruzant.

FDA accepts application for rituximab biosimilar from Sandoz

Biosimilars/News | Posted 29/09/2017

Sandoz, the generics division of Novartis, announced on 12 September 2017 that the regulatory submission for its proposed rituximab biosimilar (GP2013) had been accepted by the US Food and Drug Administration (FDA).

FDA approves bevacizumab biosimilar Mvasi

Biosimilars/News | Posted 22/09/2017

On 14 September 2017, the US Food and Drug Administration (FDA) approved its first biosimilar for the treatment of cancer.

Second etanercept biosimilar approved in Canada

Biosimilars/News | Posted 22/09/2017

Sandoz, the generics division of Novartis, announced on 21 August 2017 that its etanercept biosimilar, Erelzi, is now available in Canada.

Sanofi receives tentative FDA approval for insulin lispro biosimilar

Biosimilars/News | Posted 15/09/2017

Pharma giant Sanofi announced on 1 September 2017 that it had received tentative approval for Admelog, its insulin lispro biosimilar, from the US Food and Drug Administration (FDA).

Two trastuzumab biosimilars submitted to FDA

Biosimilars/News | Posted 15/09/2017

Two different groups announced that their trastuzumab biosimilars had been successfully submitted to the US Food and Drug Adminstration (FDA) for review.

EC approval for three rituximab biosimilars

Biosimilars/News | Posted 08/09/2017

On 13 July 2017, three rituximab biosimilars, Blizima, Rituzena (previously Tuxella) and Ritemvia, received European Commission (EC) approval.

Boehringer Ingelheim starts phase III interchangeability trial for adalimumab biosimilar

Biosimilars/News | Posted 08/09/2017

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) announced on 27 July 2017 that the first patient had been enrolled into the phase III VOLTAIRE‑X interchangeability study of its adalimumab biosimilar (BI 695501). The company says the trial ‘is the first study in the US to investigate an interchangeability designation for an adalimumab biosimilar candidate’.

FDA approves adalimumab biosimilar Cyltezo

Biosimilars/News | Posted 01/09/2017

On 25 August 2017, the US Food and Drug Administration (FDA) approved its second biosimilar version of AbbVie’s Humira (adalimumab).

EC approval for adalimumab biosimilar Imraldi

Biosimilars/News | Posted 01/09/2017

Samsung Bioepis announced on 25 August 2017 that it had received European Commission (EC) approval for its biosimilar adalimumab product Imraldi.

Hanwha to transfer biosimilar etanercept technology to Merck KGaA

Biosimilars/News | Posted 06/02/2015

South Korea’s Hanwha Chemical Corporation (Hanwha) has reportedly signed a contract with German drug maker Merck KGaA (Merck Group) to export the technology to make its biosimilar etanercept drug.

Biocad’s rituximab ‘similar biologic’ recommended for approval in India

Biosimilars/News | Posted 18/08/2017

Russian biotechnology company Biocad announced on 4 July 2017 that it would ‘soon’ receive marketing approval for its rituximab ‘similar biologic’ in India under the trade name Acellbia.

FDA accepts application for Celltrion/Teva’s rituximab biosimilar

Biosimilars/News | Posted 11/08/2017

South Korean biotechnology company Celltrion and partner Israeli generics giant Teva Pharmaceuticals (Teva) announced on 29 June 2017 that the regulatory submission for their proposed rituximab biosimilar (CT‑P10) had been accepted by the US Food and Drug Administration (FDA).

FDA rejects Pfizer’s epoetin alfa biosimilar

Biosimilars/News | Posted 14/07/2017

US pharma giant Pfizer announced on 22 June 2017 that the US Food and Drug Administration (FDA) had rejected its application for approval of its epoetin alfa biosimilar.

Biocad registers rituximab similar biotherapeutic product in Bolivia and Honduras

Biosimilars/News | Posted 14/07/2017

Russian biotechnology company Biocad announced on 6 June 2017 that it had obtained a marketing authorization for its rituximab ‘similar biotherapeutic product’ in Bolivia and Honduras under the trade name Usmal.

EC approval for etanercept biosimilar Erelzi

Biosimilars/News | Posted 07/07/2017

Sandoz, the generics division of Novartis, announced on 27 June 2017 that it had received European Commission (EC) approval for its biosimilar etanercept product Erelzi.

FDA rejects pegfilgrastim biosimilar from Coherus

Biosimilars/News | Posted 07/07/2017

Coherus BioSciences (Coherus) announced on 12 June 2017 that it had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding its candidate pegfilgrastim biosimilar, CHS‑1701.

EMA approval for adalimumab biosimilar Imraldi

Biosimilars/News | Posted 30/06/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 June 2017 that it had recommended granting marketing authorization for the adalimumab biosimilar Imraldi from Samsung Bioepis.

Adalimumab and infliximab biosimilars from Sandoz accepted for review by EMA

Biosimilars/News | Posted 30/06/2017

Sandoz, the generics division of Novartis, announced on 31 May 2017 that the regulatory submissions for its proposed adalimumab (GP2017) and infliximab (PF‑06438179) biosimilars had been accepted by the European Medicines Agency (EMA).

EC approval for rituximab biosimilar Rixathon

Biosimilars/News | Posted 23/06/2017

Sandoz, the generics division of Novartis, announced on 19 June 2017 that it had received European Commission (EC) approval for its biosimilar rituximab product Rixathon.

FDA advisors recommend approval of Pfizer’s epoetin alfa biosimilar

Biosimilars/News | Posted 16/06/2017

US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Pfizer’s biosimilar version of Amgen/Johnson & Johnson’s Epogen/Eprex/Procrit (epoetin alfa).

Celltrion making progress with biosimilars in China and Japan

Biosimilars/News | Posted 16/06/2017

South Korean biotechnology company Celltrion has announced advances in its biosimilar rituximab and trastuzumab programmes in China and Japan.

FDA advisory committee to review bevacizumab and trastuzumab biosimilars

Biosimilars/News | Posted 09/06/2017

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) announced in a Federal Register Notice on 7 June 2017 that it would be reviewing bevacizumab and trastuzumab biosimilars at its next meeting.

EMA accepts application for adalimumab biosimilar from Fujifilm Kyowa Kirin Biologics

Biosimilars/News | Posted 02/06/2017

Japan-based biosimilars developer Fujifilm Kyowa Kirin Biologics announced on 22 May 2017 that its application for approval for its proposed adalimumab biosimilar (FKB327) had been accepted by the European Medicines Agency (EMA).

EMA approval for insulin and rituximab biosimilars

Biosimilars/News | Posted 26/05/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 19 May 2017 that it had recommended granting marketing authorization for Insulin lispro Sanofi and for the rituximab biosimilars Blitzima, Ritemvia and Tuxella.

Positive phase I results for Cinfa’s pegfilgrastim biosimilar

Biosimilars/News | Posted 19/05/2017

Spanish biosimilars developer Cinfa Biotech (Cinfa) announced on 17 May 2017 that results from the second phase I study of its pegfilgrastim biosimilar (B12019) had met its primary endpoints.

Second infliximab biosimilar to be launched in Australia in 2Q 2017

Biosimilars/News | Posted 12/05/2017

Merck Sharp and Dohme (MSD) announced on 1 May 2017 its intention to launch the infliximab biosimilar Renflexis in the second half of 2017.

FDA approves biosimilar infliximab Renflexis

Biosimilars/News | Posted 04/05/2017

Samsung Bioepis announced on 24 April 2017 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Johnson & Johnson and Merck’s Remicade (infliximab).

EMA approval for etanercept and rituximab biosimilars

Biosimilars/News | Posted 28/04/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 21 April 2017 that it had recommended granting marketing authorization for the etanercept biosimilar Erelzi and for the rituximab biosimilars Rixathon and Riximyo.

Advances in ranibizumab and teriparatide biosimilars

Biosimilars/News | Posted 21/04/2017

Positive results have been reported from a ranibizumab biosimilar and a teriparatide biosimilar has entered phase III trials.

Trastuzumab biosimilar submitted for approval in Japan

Biosimilars/News | Posted 14/04/2017

Japan-based Nippon Kayaku announced on 11 April 2017 that it had submitted an application for its trastuzumab biosimilar, CT-P6, to the Ministry of Health, Labour and Welfare (MHLW) in Japan.

Basal analogue insulin ‘copy biological’ launched in Indonesia

Biosimilars/News | Posted 07/04/2017

Indonesian generics maker Kalbe Pharma (Kalbe) announced on 25 March 2017 the launch of a basal analogue insulin ‘copy biological’ in Indonesia.

EC approval for adalimumab biosimilar Amgevita

Biosimilars/News | Posted 31/03/2017

Biotech giant Amgen announced on 23 March 2017 that the European Commission (EC) had granted marketing authorization for its adalimumab biosimilar Amgevita.

Amgen submits trastuzumab biosimilar to EMA

Biosimilars/News | Posted 24/03/2017

Biotech giant Amgen announced during a conference presentation that it had filed for marketing approval for its trastuzumab biosimilar (ABP 980) in the European Union (EU).

Global settlement clears a pathway for trastuzumab biosimilar

Biosimilars/News | Posted 17/03/2017

Generics giant Mylan Pharmaceuticals (Mylan) announced on 13 March 2017 that it had agreed to the terms of a global settlement with Genentech and Roche in relation to patents for Herceptin (trastuzumab), which provides Mylan with global licences for its trastuzumab biosimilar.

Russian approval for non-originator interferon beta-1a

Biosimilars/News | Posted 10/03/2017

Russian biotechnology company Biocad announced on 3 March 2017 that the Russian Ministry of Health had approved the company’s interferon beta-1a non-originator biological drug, BCD-033. The drug is a non-originator biological of Merck’s multiple sclerosis blockbuster Rebif (interferon beta-1a).

EC approval for first cancer biosimilar Truxima

Biosimilars/News | Posted 03/03/2017

South Korean biotechnology company Celltrion announced on 22 February 2017 that it had received European Commission (EC) approval for the marketing authorization for its rituximab biosimilar Truxima.

FDA accepts application for Mylan/Biocon’s pegfilgrastim biosimilar

Biosimilars/News | Posted 24/02/2017

Mylan and Biocon announced on 16 February 2017 that the regulatory submission for their proposed pegfilgrastim biosimilar (MYL-1401H) had been accepted by the US Food and Drug Administration (FDA).

Biocon wins three-year contract to supply insulin in Malaysia

Biosimilars/News | Posted 24/02/2017

Biocon has been awarded a contract by the Malaysian Ministry of Health to supply recombinant human insulin formulations to the country, a deal reportedly worth US$68 million.

Etanercept biosimilar submitted for approval in Japan

Biosimilars/News | Posted 17/02/2017

Japan-based Mochida Pharmaceutical (Mochida) has submitted an application for marketing approval for an etanercept biosimilar (LBEC0101) to the Japanese medicines regulatory agency – the Pharmaceuticals and Medical Devices Agency (PMDA).

EMA approval for adalimumab biosimilars Amgevita and Solymbic

Biosimilars/News | Posted 10/02/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 January 2017 that it had recommended granting of marketing authorization for the adalimumab biosimilars Amgevita and Solymbic.

Sandoz withdraws biosimilar pegfilgrastim application

Biosimilars/News | Posted 03/02/2017

The European Medicines Agency (EMA) announced on 27 January 2017 that Sandoz had withdrawn the marketing application for its pegfilgrastim biosimilar (Zioxtenzo), after the agency expressed doubts about its biosimilarity and manufacturing.

Boehringer Ingelheim submits biosimilar adalimumab application to both EMA and FDA

Biosimilars/News | Posted 27/01/2017

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) announced on 18 January 2017 that its candidate adalimumab biosimilar (BI 695501) had been accepted for regulatory review by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA).

Merck Group starts phase III trial for adalimumab biosimilar

Biosimilars/News | Posted 18/03/2016

Germany’s Merck KGaA (Merck Group) announced on 2 March 2016 that it had started a phase III clinical trial for its adalimumab biosimilar (MSB11022) in patients with chronic plaque psoriasis.

Biosimilar adalimumab application submitted to EMA

Biosimilars/News | Posted 11/12/2015

Biotech giant Amgen announced on 4 December 2015 that it had submitted an application for marketing approval for its adalimumab biosimilar (ABP 501) to the European Medicines Agency (EMA).

Amgen submits biosimilar adalimumab application to FDA

Biosimilars/News | Posted 27/11/2015

Biotech giant Amgen announced on 25 November 2015 that it had submitted an application for marketing approval for its adalimumab biosimilar (ABP 501) to the US Food and Drug Administration (FDA).

Venezuelan approval for Celltrion’s Remsima

Biosimilars/News | Posted 08/05/2015

Celltrion announced on 29 April 2015 that it had received approval for its infliximab bioterapéuticos similares from the Venezuelan medicines agency, the Instituto Nacional de Higiene ‘Rafael Rangel’ (INHRR National ‘Rafael Rangel’ Institute of Hygiene).

The latest biosimilars agreements

Biosimilars/News | Posted 09/11/2012

Biosimilar is still the hottest subject around. Just a few of the latest collaborations for the development of biosimilars include agreements made on 6 November 2012 between AET BioTech and BioXpress Therapeutics; Oncobiologics and Boston Oncology; ProCognia and UniTargetingResearch; and the Innovent Biologics and Pharmatech Associates agreement made on 1 November 2012.

Japanese firms developing biosimilars

Biosimilars/News | Posted 09/11/2012

Japanese firms are definitely not dragging their heels when it comes to biosimilars. The latest agreement for biosimilar development involves LG Life Sciences (LGLS) and Mochida Pharmaceutical (Mochida), while joint venture Fujifilm Kyowa Kirin Biologics has announced it is to initiate development of a biosimilar version of bevacizumab.

Protalix plant-produced Enbrel biosimilar effective in preclinical models

Biosimilars/News | Posted 22/10/2009

Protalix Biotherapeutics reported preclinical data on pr-antiTNF, a biosimilar version of etanercept (Enbrel). Produced using the company's proprietary ProCellEx technology, pr-antiTNF is a plant cell–expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR), fused to the Fc component of a human antibody IgG1 domain. Pr-antiTNF has an identical amino acid sequence to Enbrel. In vitro and preclinical animal studies have demonstrated that pr-antiTNF exhibits similar activity to Enbrel. Specifically, pr-antiTNF binds TNF-alpha thereby inhibiting it from binding to cellular surface TNF receptors and protects L929 cells from TNF-induced apoptosis in a dose-dependent manner. In a proof-of-concept in vivo study using an established arthritis animal model, pr-antiTNF administered intraperitoneally significantly improved the clinical arthritis parameters associated with this accepted arthritis mouse model, including joint inflammation, swelling and tissue degradation. Data from the collagen-induced arthritis animal model studies are expected to be presented at an upcoming scientific conference.

Biosimilar EPO and infliximab, adalimumab get formal Japanese approval

Biosimilars/News | Posted 17/02/2010

As reported by Scrip on 21 January 2010, a large batch of new products has received final approval from Japan's ministry of health, labour and welfare, including a biosimilar erythropoietin. These and the other products given formal approval by the ministry received positive recommendations in November and December 2009.

EMA approval for rituximab biosimilar Truxima

Biosimilars/News | Posted 20/01/2017

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 16 December 2016 that it had recommended granting of marketing authorization for a rituximab biosimilar.

Benepali gains approval for extra indications

Biosimilars/News | Posted 13/01/2017

Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen, announced on 16 December 2016 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had adopted a positive opinion for the extension of indications for its etanercept biosimilar Benepali

EMA accepts application for pegfilgrastim biosimilar from Coherus

Biosimilars/News | Posted 06/01/2017

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 29 November 2016 that its application for approval for its proposed pegfilgrastim biosimilar (CHS 1701) had been accepted by the European Medicines Agency (EMA).

Bevacizumab biosimilar application submitted to EMA

Biosimilars/News | Posted 09/12/2016

Biotech giant Amgen and its partner Allergan announced on 2 December 2016 that they had submitted their application for approval for their proposed bevacizumab biosimilar (ABP 215) to the European Medicines Agency (EMA). The companies believe this submission is the first bevacizumab biosimilar application submitted to EMA.

Mylan and Biocon submit trastuzumab biosimilar to FDA

Biosimilars/News | Posted 09/12/2016

Generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon announced on 8 November 2016 that they had submitted the marketing application for their proposed trastuzumab biosimilar (Myl-1401O) to the US Food and Drug Administration (FDA).

Teva and Celltrion to partner on biosimilars

Biosimilars/News | Posted 14/10/2016

Israeli generics giant Teva Pharmaceutical Industries (Teva) and South Korean biotechnology company Celltrion announced on 7 October 2016 that they had entered into an exclusive partnership for two of Celltrion’s monoclonal antibody biosimilars in the US and Canada.

Biosimilar rituximab approved in South Korea

Biosimilars/News | Posted 02/12/2016

South Korean biotechnology company Celltrion announced on 17 November 2016 that the company had received approval for its rituximab biosimilar Truxima (CT-P10) from the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).

Mylan and Biocon submit insulin glargine biosimilar to EMA

Biosimilars/News | Posted 02/12/2016

Generics giant Mylan Pharmaceuticals (Mylan) and Indian biosimilars major Biocon announced on 3 November 2016 that the regulatory submission for their proposed insulin glargine biosimilar had been accepted for review by the European Medicines Agency (EMA).

FDA accepts application for bevacizumab biosimilar

Biosimilars/News | Posted 25/11/2016

Biotech giant Amgen and its partner Allergan, announced on 15 November 2016 that the regulatory submission for its proposed bevacizumab biosimilar (ABP 215) had been accepted for review by the US Food and Drug Administration (FDA). The companies believe this submission is the first bevacizumab biosimilar application submitted to FDA.

EMA approves biosimilars of insulin glargine and teriparatide

Biosimilars/News | Posted 18/11/2016

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 November 2016 that it had recommended granting of marketing authorization for an insulin glargine biosimilar and two teriparatide biosimilars.

Celltrion submits trastuzumab biosimilar application to EMA

Biosimilars/News | Posted 18/11/2016

South Korean biotechnology company Celltrion has, according to The Korea Herald, submitted another biosimilar application to the European Medicines Agency (EMA).

FDA accepts application for pegfilgrastim biosimilar from Coherus

Biosimilars/News | Posted 11/11/2016

Coherus BioSciences (Coherus) announced on 6 October 2016 that the US Food and Drug Administration (FDA) had accepted for review a Biologics License Application (BLA) for the company’s pegfilgrastim biosimilar candidate (CHS-1701).

Baxalta and Momenta part ways on adalimumab biosimilar

Biosimilars/News | Posted 04/11/2016

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 27 September 2016 that it would regain rights to its candidate adalimumab biosimilar M923 from Baxalta, a spinoff company from Baxter International.

Biogen’s infliximab biosimilar gets UK launch

Biosimilars/News | Posted 28/10/2016

US biotechnology company Biogen has launched their biosimilar of blockbuster anti-inflammatory Remicade (infliximab) across the UK.

Pfizer to launch infliximab biosimilar Inflectra in US

Biosimilars/News | Posted 21/10/2016

Pfizer announced on 17 October 2016 that it will begin shipment of its monoclonal antibody biosimilar Inflectra (infliximab-dyyb) to the US in late November 2016.

EMA accepts application for trastuzumab biosimilar

Biosimilars/News | Posted 07/10/2016

Samsung Bioepis, which is a joint venture between South Korean electronics giant Samsung and biotechnology company Biogen, announced on 3 October 2016 that its regulatory submission for its proposed trastuzumab biosimilar (SB3) had been accepted for review by the European Medicines Agency (EMA). The company says the marketing application was submitted in August 2016.

FDA approval for Amgen’s adalimumab biosimilar

Biosimilars/News | Posted 30/09/2016

The US Food and Drug Administration (FDA) announced on 23 September 2016 that it had approved Amgen’s biosimilar version of AbbVie’s arthritis blockbuster Humira (adalimumab).

Australia says etanercept biosimilar can be substituted

Biosimilars/News | Posted 30/09/2016

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has decided that the etanercept biosimilar Brenzys ‘could be marked as equivalent’ to the brand-name biological Enbrel on the Australian Pharmaceutical Benefits Scheme (PBS).

FDA approves biosimilar etanercept Erelzi

Biosimilars/News | Posted 23/09/2016

The US Food and Drug Administration (FDA) announced on 30 August 2016 that it had approved Sandoz’s biosimilar version of Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept).

Canadian approval for etanercept biosimilar

Biosimilars/News | Posted 16/09/2016

Merck Canada announced on 12 September 2016 that it had received approval for its etanercept biosimilar Brenzys (SB4) from Health Canada – the first subcutaneous anti-tumour necrosis factor (anti-TNF) biosimilar available in Canada.

Mylan and Biocon submit trastuzumab biosimilar to EMA

Biosimilars/News | Posted 09/09/2016

Mylan and Biocon announced on 25 August 2016 that the regulatory submission for their proposed trastuzumab biosimilar (MYL-1401O) had been accepted for review by the European Medicines Agency (EMA).

FDA accepts application for Merck’s follow-on insulin glargine

Biosimilars/News | Posted 02/09/2016

US pharma giant Merck announced on 5 August 2016 that its regulatory submission for its proposed follow-on insulin glargine product (MK-1293) had been accepted by the US Food and Drug Administration (FDA).

Janssen Biotech files lawsuits for infringement of cell culture media patent

Biosimilars/News | Posted 26/08/2016

In ongoing litigation over infliximab biosimilars, Janssen Biotech, manufacturer of Remicade (infliximab), has filed two new lawsuits against Celltrion Healthcare, Hospira and HyClone Laboratories, a subsidiary of GE Healthcare Life Sciences, over the use of cell cultures grown for use in Celltrion’s biosimilar Remsima (infliximab), and Hospira’s biosimilar Inflectra (infliximab).

Mylan and Biocon submit pegfilgrastim biosimilar to EMA

Biosimilars/News | Posted 19/08/2016

Mylan and Biocon announced on 21 July 2016 that the regulatory submission for their proposed pegfilgrastim biosimilar (MYL-1401H) had been accepted by the European Medicines Agency (EMA).

Bevacizumab similar biologics launched in India

Biosimilars/News | Posted 19/08/2016

Generics makers Reliance Life Sciences (Reliance) and Hetero have both launched similar biologics of Roche’s blockbuster cancer therapy Avastin (bevacizumab) in India.

EMA recommends approval of infliximab biosimilar Flixabi

Biosimilars/News | Posted 08/04/2016

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 1 April 2016 that it had recommended granting of marketing authorization for a biosimilar infliximab product (SB2).

Samsung Bioepis adalimumab biosimilar submitted to EMA

Biosimilars/News | Posted 12/08/2016

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 18 July 2016 that its adalimumab biosimilar candidate, SB5, had been accepted for review by the European Medicines Agency (EMA).

FDA rejects Sandoz’s biosimilar pegfilgrastim application

Biosimilars/News | Posted 05/08/2016

Novartis disclosed on 19 July 2016 that the application by its Sandoz unit to market a biosimilar version of pegfilgrastim has been rejected by the US Food and Drug Administration (FDA).

FDA advisors recommend approval of Sandoz’s etanercept biosimilar

Biosimilars/News | Posted 29/07/2016

US Food and Drug Administration’s (FDA) advisors have voted to recommend the approval of Sandoz’s biosimilar version of Amgen/Pfizer’s arthritis blockbuster Enbrel (etanercept).

Health Canada approves Inflectra biosimilar for extra indications

Biosimilars/News | Posted 24/06/2016

US-based generics maker Hospira, now part of Pfizer, announced on 14 June 2016 that its infliximab biosimilar Inflectra had received approval from Canada’s medicines regulator, Health Canada, in three extra indications.

Alvogen opening biosimilars plant in Iceland

Biosimilars/News | Posted 17/06/2016

Iceland-based biopharmaceutical company Alvotech, a sister company of US generics company Alvogen, is set to open its state-of-the-art 11,800 square meter development and manufacturing facility for biosimilars in June 2016.

Rituximab biosimilar from Sandoz accepted for review by EMA

Biosimilars/News | Posted 10/06/2016

Sandoz, the generics division of Novartis, announced on 24 May 2016 that its regulatory submission for its proposed rituximab biosimilar (GP2013) had been accepted by the European Medicines Agency (EMA).

Samsung Bioepis infliximab biosimilar accepted for review by FDA

Biosimilars/News | Posted 03/06/2016

Samsung Bioepis (a Biogen and Samsung joint venture) and Merck announced on 24 May 2016 that the US Food and Drug Administration (FDA) had accepted for review a Biologics License Application (BLA) submitted by Samsung Bioepis for the companies’ infliximab biosimilar candidate, SB2.