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. Cir.) As we covered previously, Apotex appealed the district court’s order granting Amgen a preliminary injunction in Amgen v. Apotex. Apotex requested an expedited briefing…
Today, the FDA released the latest version of its Guidance Agenda for the upcoming year. Among the new and revised draft guidances that CDER plans to release are the following three guidances concerning biosimilarity: Considerations in Demonstrating Interchangeability With a Reference Product Labeling for Biosimilar Products Statistical Approaches to Evaluation…
On January 11th, Sorrento Therapeutics announced that its partner, MabTech Ltd., had successfully completed Phase III clinical trials in China for two drugs: STI-001, a biosimilar of Eli Lilly’s Erbitux (cetuximab), and STI-002, a biosimilar of Janssen Biotech’s Remicade (infliximab). Both STI-001 and STI-002 met their primary endpoints in confirmatory,…
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 five different inflammatory conditions, including rheumatoid arthritis, plaque psoriasis, and psoriatic arthritis. This is the first biosimilar of Enbrel approved in Europe….
The U.S. Supreme Court granted certiorari in Cuozzo Speed Technologies, LLC v. Lee, No. 15-446, to review whether the PTAB applies the correct claim construction standard in post-grant proceedings created by the America Invents Act. The PTAB currently construes patent claims under the “broadest reasonable interpretation” standard. On the other…
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 reference product and its biosimilar counterpart. In its Citizen Petition, AbbVie requested that the FDA take the following actions: FDA should “ensure that applicants seeking…
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, that Amgen argued were obvious because they combined adalimumab, a known antibody, with known excipients for antibody formulations. Based on the PTAB’s claim construction…
On January 8, 2016, Mylan N.V. and Momenta Pharmaceuticals, Inc. entered into an exclusive global collaboration agreement to jointly develop, manufacture, and commercialize six of Momenta’s current biosimilar medications. According to public information about the agreement, while each company will equally share costs and profits with respect to the products,…
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, developing regulatory and legal framework around biosimilars, and the 2016 update offers analysis on the first waves of patent litigation related to biosimilars…
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 its amicus brief Wednesday. Further analysis to come.