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FDA to Hold Hearing Concerning Insulin Costs

The FDA has announced that it will hold a hearing to discuss affordability of and access to insulin products, including issues concerning the development of biosimilar and interchangeable insulin products.  The hearing will cover scientific standards for evaluating biosimilarity and interchangeability of insulin products; other regulatory considerations, such as whether…

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Phase III study report indicates Celltrion and Pfizer’s infliximab biosimilar is non-inferior to REMICADE in treating Crohn’s disease

According to a recent paper in The Lancet, a new phase 3 study shows that CT-P13, Celltrion and Pfizer’s infliximab biosimilar, is non-inferior to the reference biologic, REMICADE, for the treatment of Crohn’s disease.  CT-P13 was approved by the European Commission under the trade name Remsima® in September 2013, and…

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Kashiv Files IPRs on Amgen Process Patents

On March 7, 2019, Kashiv Biosciences filed two IPR petitions (IPR2019-00791 and IPR2019-00797) against Amgen process patents – U.S. Patent Nos. 8,940,878 and 9,643,997. The ‘878 and ‘997 patents are directed to methods to purify proteins expressed in a non-native soluble form in a non-mammalian expression system.  Kashiv asserts that claims 7-8, 11-12,…

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