Amgen has filed its reply brief in Amgen v. Apotex, which is currently on appeal before the Federal Circuit. The brief is available here. As we covered previously, Apotex filed an appeal in the Federal Circuit after the district court granted Amgen a preliminary injunction to prevent Apotex from marketing its…
The House Energy & Commerce Committee’s Subcommittee on Health met this morning to discuss implementation of the Biologics Price Competition and Innovation Act. Sean Cavanaugh, Deputy Administrator and Director of the Center for Medicare, and Janet Woodcock, Director of the Center for Drug Evaluation and Research, testified. The subcommittee’s questioning…
Japan’s Ministry of Health, Labor, and Welfare has proposed a plan to lower prices of generic and biosimilar drugs across the pharmaceutical industry. Under the proposed plan, generic drugs will be priced at 40% of brand-name drug prices, while “[b]iotechnology-based generics, such as genetically modified drugs, will be initially priced…
Coherus announced yesterday “a key achievement in support of [its] planned Biologics License Application (BLA) filing” for a proposed biosimilar of Amgen’s Neulasta® (pegfilgrastim): its proposed biosimilar, CHS-1701, has “met both primary endpoints in a double-blind, randomized, two-period, parallel-arm clinical study in 303 healthy subjects.” If accepted for FDA review,…
For the past couple of years, the World Health Organization (“WHO”) has been hard at work devising a system for standardizing the nonproprietary names of biological active substances. As we reported in an earlier post, the WHO has proposed introducing a Biological Qualifier (“BQ”), a code consisting of four random…
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…