Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On February 23, 2023, the European Medicines Agency (EMA) adopted a positive opinion for BEKEMV®. BEKEMV® is a biosimilar candidate referencing Alexion’s biological product SOLIRIS® (eculizumab), which is a recombinant...more
Last week the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) recommended two biosimilar medicines for approval. First, the CHMP adopted a positive opinion for the marketing...more
Below are regulatory and development updates regarding a number of biosimilar candidates. Today, Amgen and Allergen announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency...more
During his presentation this month at the Cowen and Company 37th Annual Health Care Conference, Amgen’s Executive Vice President and Chief Financial Officer David Meline indicated that Amgen has filed for approval in the EU...more
Amgen today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has “adopted a positive opinion” for marketing of Amgen’s biosimilar adalimumab, “recommending...more
Europe’s biosimilar market continues to develop, with biosimilars in new classes approved and pending in applications before the European Medicines Agency (EMA). 22 biosimilars are approved in eight different product classes...more
We recently reported that Amgen and Allergan had submitted an abbreviated Biologics License Application to the FDA for ABP 215, a biosimilar to Avastin® (bevacizumab). Today, the companies announced that they have also...more