The Korea Herald reports that Celltrion is on track to file applications for U.S. FDA approval for its rituximab and trastuzumab biosimilars by June. According to the article (and as previously reported), once approved, the drugs will be sold through Celltrion’s U.S. commercial partner, Teva Pharmaceutical Industries Ltd.
Generic drugs currently account for 88% of all U.S. prescriptions, yielding 10-year cost savings in excess of $1.5 trillion. There is some optimism that biosimilars will offer a similar low-cost therapeutic alternative to branded biologics. However, the Journal of the American Medical Association (JAMA) has recently published an article discussing…
On April 27, 2017, The Korea Herald and The Investor reported that Celltrion and Nippon Kayaku entered into an agreement under which Nippon Kayaku will sell Truxima, Celltrion’s biosimilar of Rituxan, in Japan. According to the articles, Nippon Kayaku has exclusive rights to sell Celltrion’s Truxima, Remsima and Herzuma, and the…
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…