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Amgen-Watson to collaborate on cancer biosimilars

US biotech signs oncology deal with generics manufacturer

US biotech Amgen and generics manufacturer Watson Pharmaceuticals are to jointly develop and commercialise several cancer biosimilars.

Amgen will be primarily responsible for developing and manufacturing the versions of biological products, with Watson taking the lead role in their commercialisation and marketing.

Watson will help Amgen out financially with development costs, contributing $400m, and the generics company will also receive royalties and sales milestones from product revenues.

The companies said the deal reflects their shared belief that biosimilars will not follow a pure brand or generic model, and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies”.

Paul Bisaro, president and CEO at Watson, said: “We believe that biosimilars are the next frontier in the evolution of the healthcare market, and we are prepared to bring all of our resources to bear in this collaboration to ensure this partnership can most effectively compete in the biosimilar space, and thereby generate significant long-term value for our respective shareholders."

Biosimilars are becoming an area of increasing interest for life science companies looking to find new ways to cope with patent losses.

Their complex development and manufacturing process means that although prices will be lower than their originator biologic products, they can still command a higher premium than that see with traditional generic versions of small molecule drugs.

Commenting on the collaboration, which will not pursue biosimilars of Amgen's own products, the biotech's president and chief operating officer Robert Bradway said biosimilars “provide an exciting long-term growth opportunity”.

Pharma interest in biologics

Other companies to declare their commitment to the biosimilar market in recent months include Merck, which said it would look to advance pipeline candidates where it can be “a first mover upon patent expiry of the originator product".

Novartis CEO Joe Jimenez also declared that biosimilars were of interest for the company as the generics market continues to grow.

Biogen Idec recently showed its dedication to biosimilars, announcing a $300m joint venture with Samsung in December 2011 to develop and manufacture products in South Korea.

The Korean government is leading the way with use of biosimilar products, with a recently launched industrial policy with the aim of giving biosimilars a 25 per cent share of the pharmaceutical market.

But there are concerns in Europe that the region is lagging behind when it comes to biosimilar uptake.

Greg Perry of the European Generic medicines Association (EGA) told PMLiVE: "I think there has been an enormous lack of concern from the political establishment about manufacturing in Europe and we are a manufacturing industry. We employ 150,000 people and I want to protect those jobs and I want to provide more jobs in Europe in the science field through biosimilars.

“Not only are we generating a market in Europe, which is taking off slowly because of a lack of incentives at a national level, but there is a huge market outside Europe for off-patent biopharmaceuticals.”

One initiative that may help to address some of these concerns came from the European Medicines Agency, which recently announced plans to update its biosimilars guidelines.

But despite its problems Europe remains ahead of the US with the number of biosimilar products approved, with the Food and Drug Administration still to announce a pathway to approve any such products for use.

21st December 2011

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