We recently posted about AbbVie’s Citizen Petition on biosimilar labeling here. We also discussed the FTC’s response to FDA’s guidance on biosimilar labeling here. In the midst of this debate, two additional organizations have recently weighed in, with petitions that stake out opposing positions on labeling. UAW Retiree Medical Benefits Trust and…
The National Institute for Health and Care Excellence (“NICE”) released guidance today establishing a preference for lower-cost biosimilars for the treatment of rheumatoid arthritis. NICE is an agency that provides cost-effectiveness and other guidance to the National Health Service (“NHS”) and other British public health services. The guidance document released today provides…
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 been approved to treat rheumatoid arthritis, Crohn’s disease, and other conditions. To prove that the proposed biosimilar is highly similar to the reference product,…
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…