Top developments in biosimilars during 2012

Much has happened in the biosimilars’ industry over the last year.

One of the most important developments during 2012 was the progress made in the US biosimilars pathway. In February 2012, FDA issued three draft guidance documents on biosimilars to assist industry in developing such products in the US. This was followed by a one-day public hearing held on 11 May 2012 to gather input from stakeholders on the draft guidances. At the meeting, stakeholders expressed their desire for FDA to harmonize with EMA’s guidances for biosimilars, which provide detailed guidance for biosimilars according to classes. As yet, no final guidelines have been issued.

In Europe, EMA has once again been busy drafting new guidelines during the last year. The long-anticipated guideline for biosimilar monoclonal antibodies came into effect in December 2012, along with a guideline for immunogenicity assessment of monoclonal antibodies. In the meantime, EMA also released a guideline to revise its overarching guideline on quality issues for biosimilars in May 2012. The guideline was open to comment from stakeholders until November 2012. EMA also released draft specific guidance for recombinant interferon beta biosimilars in January 2012 and for recombinant human insulin in December 2012. These draft guidelines were open for comments until May 2012 and June 2013.

EMA has also been busy promoting biosimilars outside of the pharmaceutical industry. In September 2012, the agency published a revised Questions and Answers document on biosimilar medicines aimed at patients and the general public.

Despite there still not being an established biosimilars pathway in the US, in October 2012 Sandoz, the generic drug division of Swiss drug giant Novartis, announced that it had started patient enrolment in a phase III clinical trial in the US for biosimilar epoetin alpha (Amgen/Johnson & Johnson’s Epogen/Procrit). Sandoz is the only biosimilars manufacturer to have more than two biosimilars on the market and is set to be a market leader, with 8–10 molecules at various stages of development.

Reliance Life Sciences also started a clinical trial for a ‘similar biologic’ version of infliximab in patients suffering with rheumatoid arthritis in India. While Teva Pharmaceutical Industries and South Korean electronics giant Samsung halted their biosimilar rituximab development, possibly due to changes in safety requirements in Europe and the US.

Biosimilar approvals have been coming thick and fast during 2012. In July 2012, South Korean biotechnology company Celltrion announced that the Korean Food and Drug Administration had approved its first monoclonal antibody, Remsima (infliximab). The company is now awaiting EMA approval, and in fact EMA is currently reviewing eight biosimilar applications.

In June 2012, Finox Biotech announced that the company’s pivotal phase III study with Afolia, a biosimilar recombinant follicle stimulating hormone (r-FSH), in patients undergoing assisted reproduction technology, had met its primary end point. This led to the Swiss-based company to submit a Marketing Authorisation Application for its biosimilar r-FSH to EMA on 30 October 2012.

In November 2012, Mochida Pharmaceuticals (Mochida) and development partner Fuji Pharma announced that they had gained approval for the first biosimilar granulocyte colony-stimulating factor (G-CSF) in Japan.

Marvel LifeSciences (Marvel) announced in November 2012 that the company would be withdrawing its EMA authorization applications for its three biosimilar human insulins. Marvel stated that ‘the decision to withdraw is in order to have sufficient time to repeat and submit bioequivalence type-1 diabetes pharmacokinetic/pharmacodynamic data on each clamp study [pivotal pharmacodynamic study] in order to comply with the planned new insulin guideline’ from EMA.

Biosimilar deals have also been on the agenda again during 2012. Some notable deals made during 2012 include those of Merck KGaA and Dr Reddy’s to collaborate on biosimilar monoclonal antibodies and Japanese digital camera maker Fujifilm Corporation (Fujifilm) and biotech firm Kyowa Hakko Kirin (Kyowa). More deals were made between AET BioTech, the biosimilars business of generics drugmaker AET (Alfred E Tiefenbacher) Group and Swiss-based biotech company BioXpress for a biosimilar version of the tumour necrosis factor (TNF) inhibitor monoclonal antibody adalimumab, as well that between Israeli glycoanalysis company ProCognia and Norway’s UniTargetingResearch for the production of biosimilars. Other agreements include those made between Oncobiologics and Boston Oncology, and US-based Pharmatech Associates and China-based Innovent Biologics.

Guidelines have also been a hot topic for 2012, with biosimilars’ guidelines being issued by India and Mexico. While, China, one of the largest pharmaceutical markets in the world, is also reportedly ready to issue biosimilars guidelines.

With the US slowly moving towards implementing practical guidance for their biosimilars pathway and further more specific guidelines emerging in Europe, the future looks bright for 2013 in the biosimilars’ market.

Source: www.gabionline.net

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