Biosimilar groups offer proposals to help US better mirror EU successes

RAPS

19 March 2019 - With 18 biosimilars approved in the US and just seven on the market, two biosimilars groups from the US and EU on Tuesday called for several structural changes so that the US can see the same competitive environment that Europe currently enjoys.

Specifically, the Biosimilars Forum and Medicines for Europe are calling for: “a fair market that allows those products that initiate lower prices to gain market share”; “a strong biosimilars pipeline with scientifically-sound and efficient, well-resourced, and timely review by FDA”; and a “framework that aligns incentives across all stakeholders to ensure appropriate uptake.”

The report uses the example of the UK, which created predictability for biosimilar sponsors ahead of product launches and allowed NHS England to benefit from multiple timely bids that optimised competition and access as soon as key patents expired.

Read Regulatory Affairs Professional Society article

Michael Wonder

Posted by:

Michael Wonder