In the past few days, Pfizer has filed petitions for IPR of two of Biogen’s patents related to rituximab: IPR2017-01166 on U.S. Patent 8,329,172 and IPR2017-01167 on U.S. Patent 8,577,244. According to the petitions, the patents are directed to methods of treating non-Hodgkin’s Lymphoma with rituximab. The petitions are posted…
Last week, Apotex filed a Citizen Petition requesting that FDA “take certain actions to ensure a robust approval process” for proposed biosimilars to Amgen’s Neulasta (pegfilgrastim). Among its requests, Apotex asks that FDA require each biosimilar applicant to conduct comparative clinical efficacy studies, including pharmacokinetics, pharmacodynamics, and immunogenicity studies, in at least…
On Monday, April 24, 2017, Fresenius Kabi and Merck KGaA announced that Fresenius will be acquiring Merck KGaA’s biosimilars business. According to Merck KGaA’s press release, Merck KGaA’s biosimilar portfolio focuses on oncology and inflammatory disorders. Both companies report that the transaction is expected to close in the second half…
The transcript of today’s Supreme Court oral argument in Sandoz v. Amgen has been posted online and is available here. As we covered briefly this morning, the questioning during today’s argument focused primarily on three points. On the 180-day notice issue: 1. Whether FDA can approve a biosimilar before a…
The Supreme Court held a 70-minute oral argument in Sandoz v. Amgen this morning. Before beginning the argument, the Chief Justice announced that the Court would give each side five extra minutes–a highly unusual step reflecting the case’s complexity. It was difficult to forecast the outcome because several members of the Court…
As a reminder to our readers, tomorrow the Supreme Court will hear oral arguments in Amgen v. Sandoz regarding the following questions: Whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide the reference product sponsor with a copy of its aBLA and/or related manufacturing information, which…
In a press release, Glenmark Pharmaceuticals announced today that the U.S. FDA has cleared Glenmark’s Investigational New Drug (IND) application of GBR 310, a proposed biosimilar of XOLAIR® (omalizumab), to initiate a first-in-human pharmacokinetics comparison study. GBR 310 is a recombinant DNA-derived humanized immunoglobulin G1 kappa monoclonal antibody. It is…
On Friday, April 21, 2017, Sandoz announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Sandoz’s biosimilars rituximab and etanercept in Europe. If approved, rituximab may be used in all indications of MabThera® and etanercept may be used in all indications of Enbrel®. According…
The FDA recently announced that the Oncologic Drugs Advisory Committee will hold a public meeting on May 25, 2017 to discuss Hospira’s application for a proposed biosimilar of Amgen’s Epogen®/Procrit® (epoetin alfa). Pfizer (Hospira’s parent) announced earlier this year that it resubmitted the application in December 2016, following FDA’s rejection…
Today, FDA approved Samsung Bioepis’s aBLA for RENFLEXIS® (infliximab-abda), a biosimilar of Janssen’s REMICADE®. According to the approved prescribing information, RENFLEXIS® is indicated for the treatment of Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis (in adult patients), rheumatoid arthritis (in combination with methotrexate), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. …