EU gives the nod to Teva/Lonza biosimilar venture

pharmafile | May 18, 2009 | News story | Manufacturing and Production, Sales and Marketing Lonza, Teva 

The European Commission has given a green light to the formation of a joint venture company between Teva and Lonza that will tap into the emerging market for biosimilar versions of biologic medicines.

Contract manufacturer Lonza and generic drug specialist Teva announced their intention to set up the venture back in January, saying they had identified biosimilars as "a major growth driver".

EC approval was the last remaining obstacle to closing the deal, said Teva and Lonza in a statement.

The companies said they will "cooperate to develop, manufacture and market a number of affordable, efficacious and safe generic equivalents of a selected portfolio of biologic pharmaceuticals".

Teva has had its sights set on the biosimilars market for some time, and last year bought CoGenesys in a $400 million deal aimed at bolstering its technical expertise in biologics manufacturing. Lonza is one of the largest contract manufacturers of biologics so adds both expertise and capacity to the venture.

Biosimilars – also known as follow-on biologics – first appeared in the European market in 2006 and now cover a range of protein-based drugs including multiple including human growth hormone, erythropoietin and white blood cell growth factors.

The products are as far as possible copies of original brands, although the complexity of biologic agents makes it impossible to show true bioequivalence, as with small-molecule generic medicines.`

At the moment there is still no biosimilar of a monoclonal antibody on the market, although analysts have suggested that the Teva/Lonza pairing could include biosimilars of Biogen Idec/Genentech's cancer drug Rituxan (rituximab) and Wyeth/Amgen's arthritis treatment Enbrel (etanercept) in its portfolio.

Europe has set out a regulatory framework that allows companies to show that their biologic is sufficiently similar to the brand name drug to warrant approval. A truncated development and registration process allows biosimilar companies to offer their products at a discount, typically 20% to 30% less than the brand.

That discounting has been driving the uptake of biosimilars in Europe, and particularly in countries which allow automatic substitution of a generic for the brand name medicine.

Progress in the big US market has been held by the lack of a regulatory route to market, and continued arguing about how to ensure safety and efficacy. However, there are already three bipartisan bills tabled which proffer a possible framework and – given that President Obama has included provision for this in his budget – it seems likely that the current impasse will be resolved.

Development of biosimilar MAbs is expected to be even more challenging than for protein-based drugs, because their complexity makes it harder to reproduce the activity profile of the original brand name product.

Related stories:

Biosimilars bill offers 12 years' marketing exclusivity

March 19, 2009

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