Tagged as: Biosimilars News

BREAKING NEWS: Federal Circuit Affirms Amgen’s $70 Million Damages Award Against Pfizer Unit

This morning, a three-judge panel of the U.S. Court of Appeals for the Federal Circuit issued a 24-page opinion affirming the district court’s judgment in favor of Amgen in its four-year long BPCIA patent ligation against Hospira, a subsidiary of Pfizer, regarding a biosimilar of Amgen’s EPOGEN (epoetin alfa). On…

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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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