The U.S. Biosimilars Market is Heating Up: Guidance from the Federal Circuit is Expected Late Spring

Fitzpatrick Case Update
April 6, 2015

It has been five years to the month since the Biologics Price Competition and Innovation Act (“BPCIA”) was signed into law, and March 2015 was the busiest month to date for the emerging U.S. biosimilars market. Currently worth approximately $1 billion a year worldwide, reports predict that this market will be worth at least $20 billion a year by 2020. This provides a strong incentive for companies like Sandoz, Celltrion, Hospira, Eli Lilly, Teva, Apotex, Accord, Ratiopharm, and others who currently market the 19 biosimilar drugs that are on sale in Europe, to seek approval in the lucrative U.S. market.

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