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,…
Samsung Bioepis Co., Ltd announced today that the FDA has accepted for review an aBLA for SB8, a bevacizumab biosimilar to Roche’s Avastin® product. If approved, SB8 will be commercialized in the US by Merck & Co.
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…
On November 7, Teva Pharmaceuticals USA, Inc., and Celltrion, Inc., announced that TRUXIMA® (rituximab-abbs) will be available in the United States beginning November 11. As we previously reported, TRUXIMA® is the first biosimilar to Genentech’s RITUXAN® (rituximab) to gain FDA approval and is currently approved for the treatment of adult…
It has been a busy week so far for biosimilar developers, with multiple collaboration and commercialization deals announced. First, on November 4, Henlius and Ascentage Pharma announced that they entered into a collaboration to conduct clinical trials of the combination therapy for oncology using Henlius’s rituximab biosimilar, HLX01, which was…
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…
As we have previously reported on Sandoz’s Biologics License Application (“BLA”) for its proposed biosimilar to Neulasta® (pegfilgrastim), Sandoz received a complete response letter from FDA, and had resubmitted its application after reportedly addressing the issues identified by FDA. Yesterday, the FDA approved Sandoz’s application. The biosimilar, named ZIEXTENZO, is an injectable formulation of pegfilgrastim-bmez, with…
Earlier this week, during its 3Q 2019 earnings call, Pfizer announced the U.S. launch dates for three of its biosimilar products: ZIRABEV (bevacizumab-bvzr), a biosimilar of Genentech’s AVASTIN, which received approval in June, will launch December 31, 2019. We previously posted that on September 20, 2019, Genentech and Pfizer settled…
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…