BI’s adalimumab biosimilar CYLTEZO (adalimumab-adbm) has recently been granted interchangeable status by the FDA. Although approved in August 2017, CYLTEZO is not scheduled to launch until July 1, 2023, pursuant to a settlement agreement with AbbVie arising from the Humira litigation. CYLTEZO is now the second interchangeable biosimilar approval granted…
Bio-Thera Solutions and Intract Pharma announced at the end of last month that they had entered into a global collaboration and licensing agreement that gives Bio-Thera access to two oral delivery technologies for monoclonal antibodies to develop treatments for chronic gastrointestinal inflammatory diseases. According to Intract’s press release, “Intract has…
On October 1, 2021, Coherus BioSciences announced that FDA has accepted for review Coherus’ BLA for CHS-201, a candidate biosimilar to Lucentis® (ranibizumab), which is indicated for neovascular age-related macular degeneration (nAMD) and several other ophthalmic conditions. The BLA was originally submitted by Coherus’ partner, BioeqAG. On October 4, 2021,…
A study recently published in Cancer Communications reported that LY01008 or BOYOUNUO, a bevacizumab biosimilar developed by Shandong Boan Biotechnology Co., Ltd. (“Shandong Boan”), a subsidiary of Luye Pharma Group Ltd. (“Luye Pharma”), demonstrated comparable safety, efficacy, immunogenicity, and pharmacokinetic profiles to the reference product AVASTIN in patients with advanced…
On September 20, 2021, the FDA issued a revised final guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” and a third revision to its draft guidance entitled “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act.” According to FDA, the guidance…
Last week, FDA issued a notice of public meeting and request for comment relating to proposed recommendations for the reauthorization of the Biosimilar User Fee Act (“BsUFA”) for fiscal years 2023 to 2027. We have previously reported on BsUFA rates for the 2022 fiscal year. The BsUFA authorizes FDA to…
On September 20, 2021, the District Court for the Northern District of Illinois entered a scheduling order in AbbVie v. Alvotech, No. 21-2258, 21-2899 (N.D. Ill.). As we previously reported, AbbVie Inc. (“AbbVie”) brought an action on April 27, 2021, in the Northern District of Illinois for patent infringement against…
On September 13, 2021 BeiGene announced the FDA’s acceptance of its BLA for tislelizumab in esophageal squamous cell carcinoma (ESCC). While tislelizumab is already approved for five indications in China, this marks the first ex-China regulatory filing for the biologic. The BLA was filed in collaboration with Novartis and is…
Samsung Bioepis, Co. Ltd. and Biogen Inc. announced yesterday that their biosimilar product BYOOVIZ™ (ranibizumab-nuna) was approved by FDA. BYOOVIZ™ is a biosimilar to LUCENTIS®, which is indicated for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. As Biogen noted, BYOOVIZ™…
Last week, results of Tanvex’s phase III study on its trastuzumab biosimilar candidate (TX05) were published in connection with the European Society for Medical Oncology’s (ESMO’s) Congress 2021. The study compared the efficacy and safety of TX05 to Herceptin in patients with HER2+ early breast cancer. The poster provides the…