As we previously reported, in July 2019 the U.S. Department of Health and Human Services (HHS) announced a Safe Importation Action Plan (Action Plan) created with the FDA to allow the importation of certain prescription drugs originally intended for foreign markets, and particularly Canada. In the fall, the Trump administration…
Investigators presented two studies on Monday at the American Society of Hematology Annual Meeting and Exposition (ASH) showing the potential for significant cost-savings by switching to biosimilar pegfilgrastim from the pegfilgrastim on-body injector (PEG-OBI). In one study, investigators demonstrated a potential for savings from a conversion to several biosimilar filgrastim…
Samsung Biologics’ third quarter report disclosed that it had suspended its research and development of its SAIT101, a biosimilar of Rituxan. As we previously reported, the rituximab product was being developed through Archigen Biotech, a joint venture with AstraZeneca. According to a report in Korea Biomedical Review, a Samsung Biologics…
Revance Therapeutics, Inc. recently announced that, because of COVID-19 travel restrictions, the FDA has been unable to complete its inspection of the manufacturing facility for Revance’s DaxibotulinumtoxinA for Injection biologic. A letter from the FDA indicated that there were no other issues with the DaxibotulinumtoxinA BLA, but that the BLA…
We are pleased to present the next webinar relating to Goodwin’s Guide to Biosimilars Litigation and Regulation in the U.S. which provides expert guidance and practical know-how for lawyers working in this growing area of the law. Our next webinar, Patent Dance Disclosures: Discovery During the Patent Dance and Beyond,…
Over the past two weeks, there have been a number of announced clinical studies and updates from biosimilar developers around the world. On November 9, Shanghai based Henlius Biotech, Inc. announced the start of its Phase I clinical trial of HLX14, the company’s biosimilar to Prolia® (denosumab). According to the…
Samsung Bioepis and Biogen issued a press release on November 18 announcing that the U.S. Food and Drug Administration has accepted for review their Biologics License Application for SB11, a proposed biosimilar of Lucentis® (ranibizumab). Ranibizumab is an anti-VEGF (vascular endothelial growth factor) therapy used to treat retinal vascular disorders,…
The results of a survey of board-certified rheumatologists in the United States about their beliefs and knowledge regarding biosimilar products were recently published in the journal Rheumatology. The online survey was conducted in May 2019 and included 19 multiple-choice questions assessing respondents’ knowledge of concepts and terminology concerning biosimilars, availability…
Emer Cooke, with 30 years’ experience in international regulatory affairs, took up her position this morning as Executive Director of EMA with a renewable five-year mandate. Previously, Ms. Cooke worked for the pharmaceutical unit of the European Commission and EMA and was the Director responsible for all medical product-related regulatory…
Yesterday, Genentech, Inc. filed a complaint in the Eastern District of Texas alleging that Centus Biotherapeutics, Ltd., Fujifilm Kyowa Kirin Biologics Co., Ltd., Fujifilm Corp., and Kyowa Kirin Co, Ltd. (collectively, Centus) proposed biosimilar to Genentech’s AVASTIN (bevacizumab) product infringes 10 U.S. patents. Genentech’s complaint, styled as a Complaint for…