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.