Hospira, Celltrion Back Apotex in Biosimilar Appeal

Hospira and Celltrion have filed a friend-of-the-court brief with the Federal Circuit Court of Appeals supporting Apotex in its dispute with Amgen over when commercial marketing of biosimilars may begin. The companies say that a lower federal court misread the provision in the Biologics Price Competition and Innovation Act (BPCIA) relating to notice of commercial marketing. They say the court found that the law authorizes an automatic, bondless injunction that delays marketing of every biosimilar product until at least 180 days after FDA approval.

“The BPCIA does not grant Amgen and other reference product sponsors such a marketing windfall,” the brief declares…. “If Amgen and Janssen had their way, every biosimilar launch would be delayed by at least 180 days after FDA has approved the product for marketing, costing the healthcare system billions of dollars and potentially harming sick patients.”