Biosimilars 'to become increasingly important in pharmaceutical industry'

Generic versions of complex biologic treatments are set to become an increasingly important market for pharmaceutical manufacturers in the coming years, due to ongoing changes in the regulatory and commercial landscape.

Until recently, biosimilars have represented a relatively minor component of the industry, due to the difficulties associated with developing and gaining approval for the drugs.

However, in recent months both Europe and the US have moved to open the regulatory process up to biosimilar manufacturers, resulting in a growing interest in the sector.

It was announced in March 2010 that the US Food & Drug Administration (FDA) is to begin approving biosimilar treatments, while 13 of the generic biologic drugs have already been approved by the European Medicines Agency (EMEA), including therapies for anaemia and low white blood cell levels.

In the UK, meanwhile, the National Institute for Health and Clinical Excellence illustrated the growing acceptance of the drugs by granting a recommendation to Sandoz's growth deficiency treatment Omnitrope, representing the first time the body has endorsed a biosimilar.

This trend is set to gather pace after EMEA executive director Thomas Lonngren told Reuters earlier this month that new guidelines on biosimilar monoclonal antibodies are to be published following review by an expert committee on drug approvals in November 2010, before potentially being adopted in the second half of 2011.

Laying down pathways for approving biosimilar versions of antibody treatments - which could include cancer and immune system therapies - will allow biosimilar manufacturers to gain access to a multi-billion pound section of the market.

The increasingly favourable climate is naturally leading many companies to step up their activities in the biosimilar sector.

For example, the Israel-based generics specialist Teva is currently in the process of applying for US regulatory approval of Neutroval, a biosimilar version of Amgen's neutropenia treatment Neupogel, which would be the company's first generic biotech drug to be sold in America.

It has also commenced clinical trials of a biosimilar version of Roche's rheumatoid arthritis and non-Hodgkin's lymphoma treatment Rituxan, the European patent for which is set to expire in 2014.

US giant Pfizer, meanwhile, completed a deal earlier this week to licence four biosimilar insulin treatments for diabetes from Asian company Biocon, which it will now commercialise globally.

Explaining the move, David Simmons, president and general manager of Pfizer's established products business unit, said: "This collaboration supports our stated efforts to become a strong player in follow-on biologics ... by adding to Pfizer's broad biotherapeutics portfolio, ranging from biosuperiors to biosimilars, across multiple therapeutic areas, which we've said we will supplement with both our in-house development efforts and selective collaborations."

However, Mr Lonngren of the EMEA also noted that those companies wishing to capitalise on the biosimilar market will face "a lot of work" before they can expect to see their new treatments approved.

For example, although the European process for biosimilar antibody approval is set to be less taxing than the US equivalent, it will nevertheless require numerous clinical trials before the complex therapies can be ratified.

Mr Lonngren noted that the procedure is "much more complicated than the normal generic business", adding that only two or three applications for biosimilar antibodies are expected to be submitted annually even after the guidelines are put in place.

However, figures cited by Reuters illustrate the benefits that have been identified by pharma firms in this emerging sector, with IMS Health statistics showing that global sales of biologic drugs amounted to around $130 billion (£82.9 billion) in 2009.

It is therefore estimated by analysts that the biosimilar market could be worth tens of billions of dollars by the second half of the coming decade. 

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