Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On February 13, 2025, the FDA approved Samsung Bioepis’s Ospomyv™ / Xbryk™ (denosumab-dssb) as the second interchangeable biosimilars of Amgen’s Prolia® / Xgeva® (denosumab). ...more
A federal district court recently dismissed a lawsuit against AbbVie and biosimilar manufacturers of adalimumab involving a novel antitrust claim against the Humira patent estate. Attorneys with Haug Partners LLP take an...more
The prevailing attitude in many quarters is that the Biologics Price Competition and Innovation Act (BPCIA) has not facilitated approval of drugs biosimilar to reference biologic drug products with sufficient alacrity and has...more
Here are our picks for the top-five most significant foreign market developments in the world of biosimilars in 2017...more
Approvals of biosimilar products in Europe continue to outpace those in the United States. 28 biosimilars are currently approved in Europe and five in the U.S. In 2017, the European Medical Agency has approved six...more
This fall marks the tenth anniversary of the effective date of the European Medicines Agency’s Guideline on Similar Biological Medicinal Products. As this blog noted previously, the EU’s biosimilar pathway both preceded the...more