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Biosimilars/News

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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).

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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.

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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.

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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.

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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.

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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).

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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.

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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).

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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).

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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.

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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.

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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.