Tag Archives: Biosimilar

Amgen, Allergan get nod for Avastin biosim; FDA’s Gottlieb making good on vow to hasten generic approvals, catch the EU.

The News: Amgen Inc. (Thousand Oaks CA) and Allergan PLC (Dublin IRL) said Thursday (September 14, 2017) that the Food and Drug Administration has approved their biosimilar version of Roche… Read more »

Amgen’s osteoporosis med almost a home run in latest trial; fate now murky on heart safety

The News: Amgen Inc. (Thousand Oaks CA) and UCB SA (Brussels) no longer expect their experimental osteoporosis drug to win US approval this year after a higher rate of serious… Read more »

FDA Panel Supports Novartis Version of Amgen Arthritis Drug

By unanimous FDA panel vote, Novartis AG’s (Basel CHE) Enbrel (etanercept) biosimilar was approved across all of its U.S. licenses. The panel, which gives nonbinding advice to the agency, voted… Read more »