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The law signed in March 2010 eliminated some of the uncertainty about the future of biosimilars in the US. Still unclear is the impact biosimilars actually will have on costs and when any savings might appear.

Biosimilar products in the European Union (EU) must go through a centralised procedure that licenses the product for use in EU Member States. Until experience grows in both approval and use of biosimilars, regulation inevitably will be somewhat case-by-case and concerns about safety will be prominent.

Europe already has some experience with the impact of biosimilars on pricing, including a price war in Germany for EPOs. Whether that experience will be repeated, however, depends on a number of factors, including the originator's pricing strategy and reservations by payers and physicians about potential risks.

Virtually all models forecast that price competition will be less intense and price declines modest in comparison to the generics model. Many models, however, miss or underestimate factors and trends that push the biosimilars market in the other direction. These include, for example, sources of supply with lower variable costs, profit incentives for entry, participation of major pharma companies and an increase in comfort levels over time.

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