Amgen announced today that FDA has accepted its Biologics License Application for ABP 501, a biosimilar of AbbVie’s Humira® (adalimumab). Adalimumab is an anti-inflammatory medication that has…
Amgen announced today that FDA has accepted its Biologics License Application for ABP 501, a biosimilar of AbbVie’s Humira® (adalimumab). Adalimumab is an anti-inflammatory medication that has…
February will be a busy month for pending BPCIA cases, with activity on the horizon in Amgen v. Apotex, Amgen v. Hospira, and Janssen v. Celltrion: Amgen v. Apotex (Fed….
Biogen Inc. announced this past Saturday that the European Commission has approved Samsung Bioepis’s proposed biosimilar of Amgen’s Enbrel (etanercept). Enbrel is a biologic drug used to treat…
On December 16, 2015, AbbVie submitted a Citizen Petition (link) (Docket No. FDA-2015-P-4935) to the FDA concerning the requirements for demonstrating interchangeability between a brand-name…
The PTAB denied institution on two of Amgen’s IPR petitions (IPR2015-01517, IPR2015-01514) against AbbVie’s Humira. The patents, 8,916,157 and 8,916,158, are directed to formulations of Humira,…
Goodwin Procter announced today the release of the 2016 edition of Biosimilars: A Guide to Regulatory and Intellectual Property Issues. The guide provides clarity to the complex,…
Yesterday Mylan, and Hospira and Celltrion (jointly) filed amicus briefs in support of Apotex’s appeal to the Federal Circuit in Amgen v. Apotex. They joined the Biosimilars Council, which filed…
Today the Biosimilars Council filed an amicus brief in support of Apotex’s Federal Circuit appeal in Amgen v. Apotex. Further analysis to…
As we have covered here, and here, Apotex is appealing the district court’s grant of a preliminary injunction to Amgen in Amgen v. Apotex. On December 30, 2015, Apotex filed…
2015 was a milestone year for biosimilars in the U.S. It was also our first year bringing you the latest biosimilars news and analysis. Here are our picks for the…