Biosimilars/News

Samsung Bioepis to launch infliximab biosimilar in South Korea

Biosimilars/News | Posted 20/05/2016

Samsung Bioepis has completed the regulatory process to enable the launch of its second biosimilar Renflexis (infliximab) in South Korea.

Samsung Bioepis starts phase III trial for bevacizumab biosimilar

Biosimilars/News | Posted 29/04/2016

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis has started a phase III clinical trial for a biosimilar version of Roche’s cancer blockbuster Avastin (bevacizumab).

New administration route for epoetin alfa biosimilar Binocrit

Biosimilars/News | Posted 22/04/2016

Sandoz, the generics division of Novartis, announced on 8 April 2016 that the European Commission (EC) has approved a type II variation for the addition of a subcutaneous (SC) route of administration for its epoetin alfa biosimilar Binocrit’s nephrology (kidney function) indication.

Korean approval for infliximab biosimilar

Biosimilars/News | Posted 11/12/2015

Samsung Bioepis and partner Merck announced on 4 December 2015 that Samsung Bioepis had received approval for its infliximab biosimilar Renflexis from the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).

EMA recommends approval of etanercept biosimilar

Biosimilars/News | Posted 27/11/2015

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 19 November 2015 that it had recommended granting of marketing authorization for a biosimilar etanercept product (SB4).

Biosimilar etanercept approved in South Korea

Biosimilars/News | Posted 11/09/2015

US pharma giant Merck and South Korean biosimilars maker Samsung Bioepis announced on 8 September 2015 the approval of their biosimilar etanercept product Brenzys by the Ministry of Food and Drug Safety (MFDS) in Korea.

Samsung adds 48-week extension to SB4 biosimilar study

Biosimilars/News | Posted 27/04/2015

Samsung Bioepis has added a 48-week extension to the phase III study of its candidate etanercept biosimilar SB4 in rheumatoid arthritis patients.

Merck outlines biosimilars programme

Biosimilars/News | Posted 17/04/2015

During the 35th Annual Health Care Conference held on 2−4 March 2015 in Boston, USA, US pharma giant Merck outlined its biosimilars programme.

Samsung Bioepis submits second biosimilar to EMA

Biosimilars/News | Posted 03/04/2015

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 13 March 2015 that its infliximab biosimilar candidate, SB2, had been accepted for review by the European Medicines Agency (EMA).

Biosimilar etanercept submitted for approval in EU

Biosimilars/News | Posted 23/01/2015

South Korean electronics giant Samsung and biotechnology company Biogen Idec’s joint venture Samsung Bioepis announced on 21 January 2015 that its etanercept biosimilar candidate, SB4, had been accepted for review by the European Medicines Agency (EMA).

Biogen and Samsung make deal for marketing anti-TNF biosimilars

Biosimilars/News | Posted 17/01/2014

US biotechnology company Biogen Idec (Biogen) and Korean electronics giant Samsung announced on 17 December 2013 that Biogen has exercised its right to enter into an agreement to commercialize anti-tumour necrosis factor (TNF) biosimilar product candidates in Europe.

Trials to start for biosimilar infliximab and etanercept

Biosimilars/News | Posted 14/06/2013

Pfizer is to start a phase I study for its biosimilar infliximab candidate (PF-06438179) and Samsung Bioepis has initiated a phase III clinical trial for its biosimilar etanercept (SB4), according to entries on the US and EU clinical trials websites.

BioOutsource launches ready-to-use biosimilarity assays

Biosimilars/News | Posted 15/04/2016

Sartorius Stedim BioOutsource (BioOutsource), a subsidiary of Sartorius Stedim Biotech, has launched a range of ready-to-use assays for testing biosimilarity. The assays are available for biosimilars of Hoffmann–La Roche/Chugai’s rheumatoid arthritis treatment Actemra (tocilizumab), Centocor’s psoriasis treatment Stelara (ustekinumab) and Novartis/Genentech’s age-related macular degeneration drug Lucentis (ranibizumab).

FDA approves infliximab biosimilar Inflectra

Biosimilars/News | Posted 08/04/2016

The US Food and Drug Administration (FDA) announced on 5 April 2016 that it had approved the country’s second biosimilar Inflectra (infliximab).

Biocon receives Japanese approval for insulin glargine biosimilar

Biosimilars/News | Posted 01/04/2016

India-based biologicals specialist Biocon announced on 28 March 2016 that it had received approval from Japan’s Ministry of Health, Labour and Welfare (MHLW) for its insulin glargine biosimilar.

Epirus starts phase III trial for infliximab biosimilar

Biosimilars/News | Posted 11/03/2016

US-based biologicals company Epirus Biopharmaceuticals (Epirus) announced on 9 February 2016 that it had started a phase III trial for its infliximab biosimilar (BOW015).

Trastuzumab non-originator biological approved in Russia

Biosimilars/News | Posted 26/02/2016

Russian biotechnology company Biocad announced on 20 January 2016 that the Russian Ministry of Health had approved the company’s trastuzumab non-originator biological, BCD-022. The drug is a non-originator biological of Roche’s breast cancer blockbuster Herceptin (trastuzumab).

FDA advisers recommend approval of Celltrion’s infliximab biosimilar

Biosimilars/News | Posted 19/02/2016

US Food and Drug Administration’s (FDA) advisers have voted to recommend the approval of Celltrion’s biosimilar version of Johnson & Johnson and Merck’s arthritis treatment Remicade (infliximab).

EMA accepts application for pegfilgrastim biosimilar

Biosimilars/News | Posted 19/02/2016

Sandoz, the generics division of Novartis, announced on 11 February 2016 that its regulatory submission for its proposed pegfilgrastim biosimilar (LA-EP2006) had been accepted by the European Medicines Agency (EMA).

Kyowa to market Sandoz’s rituximab biosimilar in Japan

Biosimilars/News | Posted 12/02/2016

Biotech firm Kyowa Hakko Kirin (Kyowa) announced on 25 January 2016 that it had made a deal with Sandoz, the generics division of Novartis, for exclusive marketing rights to Sandoz’s biosimilar rituximab in Japan.

Australian approval for infertility biosimilar Bemfola

Biosimilars/News | Posted 05/02/2016

Switzerland-based Finox Biotech (Finox) announced on 30 November 2015 that it had gained approval from Australia’s drug regulator, the Therapeutic Goods Administration (TGA), for follitropin alfa biosimilar Bemfola.

Filgrastim follow-on biological approved in Brazil

Biosimilars/News | Posted 29/01/2016

Brazil’s medicines agency, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), announced on 20 October 2015 that it had approved the follow-on biological medicine Fiprima (filgrastim).

Bevacizumab non-originator biological approved in Russia

Biosimilars/News | Posted 22/01/2016

Russian biotechnology company Biocad announced on 30 November 2015 that the Russian Ministry of Health had approved the company’s bevacizumab non-originator biological drug, BCD-021. The drug is a non-originator biological of Roche’s cancer blockbuster Avastin (bevacizumab).

EMA accepts application for etanercept biosimilar

Biosimilars/News | Posted 15/01/2016

Sandoz, the generics division of Novartis, announced on 8 December 2015 that the regulatory submission for its proposed etanercept biosimilar (GP2015) had been accepted by the European Medicines Agency (EMA).

FDA approves first follow-on insulin glargine treatment

Biosimilars/News | Posted 08/01/2016

The US Food and Drug Administration (FDA) announced on 16 December 2015 that it had approved Eli Lilly/Boehringer Ingelheim’s biosimilar version of Sanofi’s Lantus (insulin glargine) diabetes treatment.

FDA accepts application for pegfilgrastim biosimilar

Biosimilars/News | Posted 04/12/2015

Sandoz, the generics division of Novartis, announced on 18 November 2015 that its regulatory submission for its proposed pegfilgrastim biosimilar had been accepted by the US Food and Drug Administration (FDA).

Infliximab price wars

Biosimilars/News | Posted 04/12/2015

Merck has reportedly slashed the price of its blockbuster Remicade (Infliximab) in the UK in order to fight off growing competition from infliximab biosimilars.

Celltrion submits rituximab biosimilar application to EMA

Biosimilars/News | Posted 20/11/2015

South Korean biotechnology company Celltrion has, according to Business Korea, submitted a second biosimilar application to the European Medicines Agency (EMA).

Formycon starts phase III trial for ranibizumab biosimilar

Biosimilars/News | Posted 13/11/2015

German biosimilars companies Formycon and Bioeq announced on 7 October 2015 that they had initiated a pivotal phase III clinical trial with their candidate ranibizumab biosimilar (FYB201).

Boehringer Ingelheim stops biosimilar rituximab development

Biosimilars/News | Posted 30/10/2015

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) has reportedly halted clinical development for its biosimilar version (BI 695500) of Roche’s blockbuster leukaemia treatment Rituxan/MabThera (rituximab).

Insulin glargine biosimilar in US delayed until end 2016

Biosimilars/News | Posted 23/10/2015

Pharmaceutical majors Eli Lilly and Sanofi announced on 28 September 2015 that the two companies had agreed to end the legal dispute over biosimilar insulin glargine in the US and to discontinue similar disputes worldwide.

Baxalta and Momenta start phase III trial for adalimumab biosimilar

Biosimilars/News | Posted 16/10/2015

Baxalta – a spinoff company from Baxter International – and US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 5 October 2015 that they had started a phase III clinical trial for their adalimumab biosimilar (M923) in patients with chronic plaque psoriasis.

FDA accepts application for etanercept biosimilar

Biosimilars/News | Posted 09/10/2015

Sandoz, the generics division of Novartis, announced on 2 October 2015 that the US Food and Drug Administration (FDA) had accepted its application for its etanercept biosimilar (GP2015).

Another infliximab switching trial started

Biosimilars/News | Posted 02/10/2015

In The Netherlands another study has been initiated into the effects of switching patients from originator infliximab to biosimilar infliximab.

Biosimilar production in Malaysia

Biosimilars/News | Posted 25/09/2015

Malaysian biotech firm Inno Bio Ventures has announced the signing of a memorandum of understanding (MoU) with Iranian firm Aryogen Biopharma. The agreement will lead to the production of the first Malaysian-made biosimilars for the local and regional market.

Biosimilar insulin launched in the UK

Biosimilars/News | Posted 18/09/2015

Eli Lilly and Boehringer Ingelheim announced on 26 August 2015 the UK launch of their biosimilar insulin glargine, Abasaglar.

Zarxio first biosimilar to be launched in US

Biosimilars/News | Posted 04/09/2015

The US has entered a new era in medicines with the historic launch of the country’s first biosimilar. Sandoz, the generics division of Novartis, announced on 3 September 2015 that it had launched its filgrastim biosimilar, Zarxio (filgrastim-sndz), in the US.

Darbepoetin alfa ‘similar biologic’ launched in India

Biosimilars/News | Posted 20/06/2014

India-based Hetero, one of the largest manufacturers and suppliers of active pharmaceutical ingredients (APIs) to the Indian pharmaceutical industry, announced on 18 June 2014 the launch of its first ‘similar biologic’ product Actorise, a ‘similar biologic’ of darbepoetin alfa in India.

Rituximab similar biologic launched in India

Biosimilars/News | Posted 28/08/2015

India-based generics maker Hetero Group (Hetero) announced on 3 August 2015 the launch of its product Maball, a ‘similar biologic’ of rituximab, in India.

Non-originator infliximab approved in Russia

Biosimilars/News | Posted 14/08/2015

South Korean biotechnology company Celltrion announced that it had received approval for its non-originator infliximab, Remsima, from Russia’s Ministry of Health (Министерство здравоохранения Российской Федерации; Rosminzdrav) on 13 July 2015.

Biosimilars licensing agreements for AMP and Formycon

Biosimilars/News | Posted 03/07/2015

German biosimilars companies AMP Biosimilars (AMP) and Formycon have both made out-licensing agreements for their candidate biosimilars.

Ranibizumab similar biologic launched in India

Biosimilars/News | Posted 26/06/2015

Indian generics maker Intas Pharmaceuticals (Intas) announced on 19 June 2015 the launch of its ranibizumab similar biologic in India.

Indian drugmakers make progress with candidate biosimilars

Biosimilars/News | Posted 05/06/2015

India-based biologicals specialist Biocon announced on 7 May 2015 that it had made clinical progress in its partnered programmes with US generics maker Mylan.

Baxter and Coherus amend biosimilar etanercept collaboration

Biosimilars/News | Posted 29/05/2015

US-based biosimilars developer Coherus BioSciences (Coherus) and Baxter International (Baxter) announced on 15 April 2015 that they had amended some of the financial terms of their collaboration agreement for CHS-0214, an etanercept biosimilar candidate.

Latin American deal for infliximab biosimilar

Biosimilars/News | Posted 29/05/2015

US-based Epirus Biopharmaceuticals (Epirus) announced on 14 May 2015 that it had made a deal with biosimilars specialist mAbxience, a subsidiary of Spanish healthcare firm the Chemo Group, for Latin America with respect to the infliximab biosimilar made by Epirus.

Australian approval for biosimilar insulin

Biosimilars/News | Posted 22/05/2015

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has given a positive recommendation for the listing of Eli Lilly’s biosimilar insulin glargine, Basaglar in the country’s Pharmaceutical Benefits Scheme (PBS). Basaglar is the first biosimilar insulin to be approved in Australia, providing an alternative, affordable treatment option for patients suffering from diabetes.

Iran approves its first rituximab biogeneric

Biosimilars/News | Posted 15/05/2015

In May 2015, Iran’s National Regulatory Authority, the Food and Drug Organization (FDO), approved its first rituximab biogeneric (Zytux). The medicine received its marketing authorization based on the previously published national guideline for marketing of biogenerics in Iran [1].

Biosimilars deals coming thick and fast

Biosimilars/News | Posted 14/08/2014

Biosimilar collaborations are still the latest fashion, with new deals being made between Cipla and Mabpharm, Strides Arcolab and Oncobiologics, and NeuClone and the Serum Institute.

Brazil approves first monoclonal antibody follow-on biological

Biosimilars/News | Posted 04/05/2015

Brazil’s medicines agency, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA), announced on 27 April 2015 that it had approved its first follow-on biological medicine through ‘the development by comparability’.

Infliximab SEB launched in Canada

Biosimilars/News | Posted 10/04/2015

US-based generics major Hospira announced on 30 March 2015 the availability of its infliximab subsequent entry biologic (SEB) Inflectra in Canada, the country’s first SEB monoclonal antibody therapy.

US court rejects Amgen’s bid to block filgrastim biosimilar

Biosimilars/News | Posted 27/03/2015

On 19 March 2015, the US District Court for North California rejected US biotechnology giant Amgen’s request for a preliminary injunction blocking Sandoz, the generics division of Novartis, from launching its filgrastim biosimilar Zarxio (filgrastim-sndz).

Infliximab biosimilars tighten grip on European markets

Biosimilars/News | Posted 20/03/2015

The progress of biosimilars onto the European market continues apace with an announcement from Mundipharma that Remsima (infliximab biosimilar) is being launched in several major markets, including Germany and The Netherlands.

FDA approves its first biosimilar

Biosimilars/News | Posted 13/03/2015

The US Food and Drug Administration (FDA) announced on 6 March 2015 that it had approved Zarxio (filgrastim-sndz) injection, the first biosimilar ever to be approved in the US, for the five indications for which US-licensed Neupogen is approved. FDA found Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy agent Neupogen (filgrastim), which is used to help prevent infections in cancer patients receiving chemotherapy.

Second Apotex biosimilar under FDA review

Biosimilars/News | Posted 13/03/2015

Canada-based Apotex announced on 13 February 2015 that the US Food and Drug Administration (FDA) had accepted for filing the company’s application for a biosimilar version of Amgen’s Neupogen (filgrastim).

Hospira launches infliximab biosimilar in major European markets

Biosimilars/News | Posted 06/03/2015

Injectable generics specialist and biosimilars maker Hospira announced on 16 February 2015 that it was launching its infliximab biosimilar, Inflectra, in several major European markets. Inflectra, a treatment for inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease, will now be marketed in 24 European countries, nearly doubling its presence across Europe.

FDA delays meeting to evaluate infliximab biosimilar

Biosimilars/News | Posted 27/02/2015

The US Food and Drug Administration (FDA) has postponed a meeting of its Arthritis Advisory Committee, which was to discuss an infliximab biosimilar.

Accord launches biosimilar filgrastim in Europe

Biosimilars/News | Posted 27/02/2015

Generics company Accord Healthcare (Accord) has announced the launch of their first European approved biosimilar Accofil (filgrastim), indicated for the treatment of chemotherapy induced neutropenia.

Hospira and Pfenex to collaborate on ranibizumab biosimilar

Biosimilars/News | Posted 20/02/2015

US-based injectables specialist Hospira and US biotechnology firm Pfenex announced on 10 February 2015 that they had entered into an agreement to exclusively develop and commercialize for worldwide sales PF582 (ranibizumab), Pfenex’s leading biosimilar candidate.

FDA advisers to consider infliximab biosimilar

Biosimilars/News | Posted 13/02/2015

The US Food and Drug Administration (FDA) revealed in a Federal Register publication on 10 February 2015 that it has asked advisers to review a second biosimilar application.

Torrent licenses three ‘similar biologics’ from Reliance

Biosimilars/News | Posted 13/02/2015

Torrent Pharmaceuticals (Torrent) announced on 25 December 2014 that it had made an exclusive licensing agreement with fellow Indian drugmaker Reliance Life Sciences (Reliance) for the marketing of three ‘similar biologics’ in India.

FDA advisers recommend approval of filgrastim biosimilar

Biosimilars/News | Posted 09/01/2015

US Food and Drug Administration (FDA) advisers have voted unanimously to recommended approval for Sandoz’s biosimilar version of Amgen’s Neupogen (filgrastim), a development that could make complex biological therapies more readily accessible in the US.

Merck KGaA plans further investment in biosimilars

Biosimilars/News | Posted 10/10/2014

German pharma giant Merck KGaA announced on 18 September 2014 plans to step up investments in biosimilars during 2015.

Japanese approval for insulin glargine biosimilar

Biosimilars/News | Posted 30/01/2015

Partners Eli Lilly and Boehringer Ingelheim confirmed on 19 January 2015 that they had received Japanese regulatory approval for their biosimilar insulin glargine product (LY2963016).

Norwegian study may be slowing adoption of biosimilar infliximab

Biosimilars/News | Posted 24/10/2014

Norway is funding clinical studies in which patients will be switched from originator biological drugs to biosimilars [1]. However, some have speculated that the NOR-SWITCH study is actually slowing the adoption of biosimilar infliximab in Norway.

Adalimumab similar biologic launched in India

Biosimilars/News | Posted 30/01/2015

Indian generics maker Zydus Cadila announced on 9 December 2014 the launch of its adalimumab similar biologic in India.

Mabion starts phase III trial for rituximab biosimilar

Biosimilars/News | Posted 23/01/2015

Polish biologicals company Mabion announced on 25 November 2014 that it had received the consent of the appropriate regulatory authorities in Croatia, Bosnia and Herzegovina, Serbia and Poland to start a phase III clinical trial for its rituximab biosimilar (MabionCD20) in patients with diffuse large B-cell lymphoma.

Hospira submits application to FDA for epoetin alfa biosimilar

Biosimilars/News | Posted 16/01/2015

US-based injectables specialist Hospira announced on 12 January 2015 that it had submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its epoetin alfa biosimilar Retacrit.

Apotex pegfilgrastim biosimilar under FDA review

Biosimilars/News | Posted 16/01/2015

Canada-based Apotex announced on 17 December 2014 that the US Food and Drug Administration (FDA) had accepted for filing the company’s application for a biosimilar version of Amgen’s Neulasta (pegfilgrastim).

First infliximab ‘similar biologic’ launched in India

Biosimilars/News | Posted 09/01/2015

India-based Ranbaxy Laboratories (Ranbaxy) announced on 1 December 2014 that it had launched its infliximab ‘similar biologic’, BOW015 in India. This is the first infliximab similar biologic to be launched in India.

Rituximab non-originator biological approved in Russia

Biosimilars/News | Posted 25/04/2014

Russian biotechnology company Biocad announced on 17 April 2014 that the Russian Ministry of Health has approved the company’s rituximab non-originator biological, AcellBia (BCD-020). The drug is a non-originator biological of Roche’s rheumatoid arthritis blockbuster MabThera/Rituxan (rituximab).

Amgen starts phase III trial for biosimilar rituximab

Biosimilars/News | Posted 26/09/2014

Biologicals major Amgen is carrying out a global phase III clinical trial for a biosimilar version of Roche’s blockbuster arthritis/non-Hodgkin’s lymphoma drug MabThera/Rituxan (rituximab).

Biosimilar infliximab launched in Japan

Biosimilars/News | Posted 05/12/2014

Japanese pharma firm Nippon Kayaku announced on 28 November 2014 the launch of its infliximab biosimilar, Infliximab BS, in Japan.

Biocad and Epirus to invest in follow-on biological products in Brazil

Biosimilars/News | Posted 31/10/2013

Biocad Russia is to open a US$40 million facility to produce three follow-on biological products in Brazil.

Momenta gains approval to start biosimilar adalimumab trial in Europe

Biosimilars/News | Posted 12/12/2014

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 1 December 2014 the acceptance by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a clinical trial application to initiate a clinical trial for its adalimumab biosimilar, M923.

Stada to in-license adalimumab biosimilar

Biosimilars/News | Posted 05/12/2014

German generics giant Stada Arzneimittel (Stada) announced on 18 November 2014 that it was in negotiations to in-licensing an adalimumab biosimilar.

Amgen expands biosimilars programme

Biosimilars/News | Posted 28/11/2014

Biologicals major Amgen is expanding its biosimilars portfolio to include nine different molecules.

Amgen launches biosimilars info app

Biosimilars/News | Posted 21/11/2014

Biologicals major Amgen has launched an app which aims to provide a source of information about biosimilars.

Amgen sues Sandoz over filgrastim biosimilar

Biosimilars/News | Posted 14/11/2014

Biologicals major Amgen is suing Sandoz to stop the biosimilars maker from marketing a biosimilar of its top-selling product Neupogen (filgrastim) in the US. Amgen claims in its lawsuit that Sandoz did not follow the rules for biosimilar development.

Study into switching from Aranesp to biosimilar epoetin alfa

Biosimilars/News | Posted 07/11/2014

Biologicals major Amgen has started recruiting patients for a clinical trial to study the effect of switching patients from the originator biological Aranesp (darbepoetin alfa) to biosimilar epoetin alfa, in other words, from a long-acting to a short-acting epoetin.

Coherus sells shares to raise funds for biosimilars programme

Biosimilars/News | Posted 07/11/2014

US-based biosimilars developer Coherus BioSciences (Coherus) is looking for further funding for its biosimilar programme. The company is preparing to sell shares in the company in order to raise funds to get three of the biosimilars in its pipeline through clinical trials.