Biocon, a prominent Indian biopharma company, entered into a partnership with Mylan in 2009 for joint research and development of biosimilars. That partnership now appears to be yielding…
Biocon, a prominent Indian biopharma company, entered into a partnership with Mylan in 2009 for joint research and development of biosimilars. That partnership now appears to be yielding…
Today, Sandoz announced that the EMA has accepted its Marketing Authorization Application for its biosimlar to Amgen’s Neulasta, used to prevent infection in patients with compromised immune…
Yesterday, the FDA’s Advisory Committee overwhelmingly supported approval of Celltrion’s infliximab product, which is a biosimilar for Janssen’s Remicade product. At the District Court…
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…
Coherus announced yesterday “a key achievement in support of [its] planned Biologics License Application (BLA) filing” for a proposed biosimilar of Amgen’s Neulasta®…
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…
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…