The World Health Organization (WHO) announced today plans to launch a pilot project for prequalifying biosimilar medicines later this year. The project will initially focus on biosimilar versions of two cancer treatments, rituximab and trastuzumab, with possible expansion into prequalifying insulin. WHO will begin accepting applications this September and will…
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…
With the Supreme Court’s pending decision in Sandoz v. Amgen, the interpretation of the patent dance provisions of the BPCIA has been a hot topic here on the blog. For an in-depth analysis of patent dance strategies employed by biosimilar applicants to date, check out this article in Bloomberg’s Life Sciences…
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…
Stay tuned for an in depth analysis of the arguments.
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…