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.”

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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