This week, in the Immunex v. Samsung Bioepis BPCIA litigation regarding ETICOVO (etanercept-ykro), Samsung Bioepis’s biosimilar of ENBREL, the New Jersey district court entered a Consent Injunction Order that prohibits Samsung Bioepis from using, importing, offering to sell, or selling any etanercept product in the United States, except as allowed…
Here are our picks of some legal developments to keep an eye out for in the new year: Federal Circuit Decisions on Bevacizumab and Trastuzumab Preliminary Injunctions: Appeals are pending on the District of Delaware’s denial of preliminary injunctions in cases brought by Genentech against Amgen regarding Amgen’s bevacizumab and…
As we close out another calendar year, we look back at the top legal developments of 2019 that could influence the market for biologics and biosimilars. These five major court decisions will likely impact the legal strategy in the biosimilars space in 2020 and moving forward. 1. On December 16,…
Today, the World Health Organization (“WHO”) prequalified Samsung Bioepis’s breast cancer biosimilar trastuzumab – WHO’s first biosimilar prequalification. Prequalification is “a service provided by WHO to assess the quality, safety and efficacy of those products that address global public health priorities.” The WHO noted that the global average price of…
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…
On December 10, 2019, the House Democrats and Trump administration reached an agreement on the United States-Mexico-Canada Agreement (USMCA), which would replace the North American Free Trade Agreement (NAFTA) of 1994. According to CNBC, the final version does not include a 10-year data exclusivity period for biologic drugs that was part…
On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen. The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review (IPR) initiated by Pfizer. In October 2018, Pfizer succeeded in persuading the…
On November 14, 2019, the parties in the Amgen v. Accord (previously Apotex) follow-on BPCIA litigation filed a Stipulation of Dismissal, agreeing “to the dismissal, without prejudice, of all remaining claims and counterclaims in this action with the parties to bear their own costs and attorney’s fees.” The next day,…
On November 15, the FDA approved Pfizer’s Humira® biosimilar, ABRILADA (adalimumab-afzb). The acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, Sarah Yim, M.D., announced the approval as one of nine new biosimilar products the FDA “has taken action on…
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…