Tagged as: Biosimilars News

China NMPA Approves Adalimumab Biosimilar

On November 7, Bio-Thera Solutions, Ltd. announced that the China National Medical Products Administration (NMPA) approved QLETLI®, a biosimilar to AbbVie’s HUMIRA® (adalimumab). QLETLI® is the first adalimumab biosimilar approved by the NMPA and has been approved for the treatment of three autoimmune diseases, including rheumatoid arthritis, ankylosing spondylitis, and plaque…

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Big Conversations: In-House Counsel Discuss the Past, Present, and Future of Biosimilars Market Entry In the EU and U.S. (Part 4)

In a continuation from Part 3 of this panel discussion, Goodwin and Bristows continue their discussion with senior in-house counsel at the forefront of the biosimilars industry to discuss the pace of biosimilars market entry in the EU and U.S., why the pace of biosimilars market entry has been different…

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Researchers Publish Results Of Biosimilar-Switching Studies

In 2017, the Health Department of Brazil’s Federal District ordered that patients currently prescribed Remicade (infliximab) be switched over to the biosimilar, Remsima.  Earlier this month, researchers in Brazil published a one-year follow-up study of patients who underwent the switch.  They reported that, “[l]ike previous European studies, [their] results suggest…

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Tanvex receives Complete Response Letter from FDA for its Proposed Filgrastim Biosimilar Product

On September 25, 2019, Tanvex BioPharma announced that it received a complete response letter from the U.S. FDA indicating that Tanvex’s abbreviated Biologics License Application (aBLA) for its proposed filgrastim biosimilar, TX01, was not in condition for approval. Tanvex reported that FDA “did not request additional clinical data or express…

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Biocad and Shanghai Pharma Holding Announce Joint Venture in China

Last month, Biocad and Shanghai Pharma Holding (SPH) announced that they have established a joint venture, SPH-Biocad, to commercialize Biocad’s biopharmaceutical portfolio in China. According to the companies’ press releases, SPH-Biocad will begin by commercializing six of Biocad’s biopharmaceutical products, including three biosimilars and three innovative biologics. According to SPH,…

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