Updates on Rituximab Proposed Biosimilars

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The past few days have seen a lot of activity on the rituximab biosimilar front.

  • According to a joint press release, Sanofi and JHL Biotech, a biopharmaceutical company based in China, formed an alliance to collaborate on the development and commercialization of a rituximab biosimilar and various pharmaceutical products in China.  The agreement includes a large investment by Sanofi in JHL stock, and an upfront payment by Sanofi of $21 million for the exclusive rights to JHL’s biosimilar of rituximab.
  • Sandoz announced that its rituximab biosimilar met its primary endpoint in a study designed to demonstrate equivalence to Mabthera®, the brand name under which Roche sells rituximab outside of the United States.   According to the press release, the study confirmed that Sandoz’s rituximab biosimilar and Mabthera® “were equivalent.”  The results were presented at the Annual Meeting of the American Society of Hematology, which is taking place now, from December 3-6, 2016.
  • Celltrion presented an abstract at the Annual Meeting of the American Society of Hematology this week which, according to a press release posted on Business Wire, “demonstrated similarity of PK” between its proposed biosimlar, CT-P10, and rituximab in patients with advanced follicular lymphoma.  The press release further stated that “this evidence of similarity builds on clinical experience of CT-P10 along with the data in patients with rheumatoid arthritis (RA) which shows compelling similarity in PK, PD, efficacy, safety and immunogenicity.”
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