On April 10, 2023, Celltrion confirmed the bioequivalence of CT-P39 to treat allergic asthma and chronic urticaria, through its interim results from its global phase 3 clinical trials at 24 weeks. CT-P39 is a biosimilar referencing Xolair (ingredient: omalizumab), which is an antibody biopharmaceutical that treats allergic asthma, chronic urticaria,…
According to news reports, Celltrion recently launched VEGZELMA (bevacizumab) in Japan. In September 2022, the drug received sales approval from the Japanese Ministry of Health, Labor and Welfare for the treatment of metastatic colorectal cancer, non-small cell lung cancer, and more. Japan is home to the world’s second largest bevacizumab…
As we ring in the new year, we look back at the top legal developments of 2022 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at the Federal Circuit, and at the PTAB. Below is our recap of…
On November 22, 2022, Amneal Pharmaceuticals, Inc. (“Amneal”) announced the commercial launch of RELEUKO, a biosimilar referencing Neupogen. RELEUKO is used to treat neutropenia which is commonly experienced by patients undergoing chemotherapy. RELEUKO is Amneal’s second U.S. biosimilar launch. As we previously reported, Amneal announced the launch of its first…
The U.S. Patent and Trademark Office (USPTO) recently published a request for comments addressing a variety of topics related to generic drug and biosimilar competition. In July 2021, President Biden issued an Executive Order on “Promoting Competition in the American Economy,” which directed the Secretary of Health & Human Services…
As we previously reported, on June 28, 2020, Genentech, Inc. (“Genentech”) filed a complaint against Samsung Bioepis Co., Ltd. (“Samsung”) in the District of Delaware, alleging infringement of fourteen patents under the BPCIA based on Samsung’s submission of an aBLA for SB8, a proposed biosimilar of AVASTIN (bevacizumab). On September 7, 2022, Genentech and Samsung filed…
Mylan recently filed two IPR petitions seeking cancellation of various claims of patents assigned to Regeneron relating to dosing regimens for EYLEA® (aflibercept): IPR2022-01225 challenging claims 1, 3-11, 13-14, 16-24, and 26 of U.S. Patent No. 10,130,681, and IPR2022-01226 challenging claims 1-9, 34-39, 41-43, and 45 of U.S. Patent No….
On May 31, 2022, Sandoz announced the launch of a new global initiative called “Act4Biosimilars” to help address health inequity and inequality worldwide. Act4Biosimilars aims to increase patient access to advanced medicines by facilitating greater approvability, accessibility, acceptability and affordability (the 4 A’s) of biosimilars. The initiative is supported by…
Late last week, Regeneron Pharmaceuticals, Inc. filed an antitrust complaint against Amgen Inc. in the U.S. District Court for the District of Delaware. Regeneron alleges that “Amgen is engaged in a persistent exclusionary campaign to deny patients the life-saving benefits of [] Regeneron’s cholesterol-reducing medication, Praluent® (alirocumab).” According to Regeneron,…
In January 2022, Biogen Inc. announced it had reached an agreement to sell its equity stake in the Samsung Bioepis joint venture to partner Samsung Biologics. On April 20, 2022, Samsung Biologics and Biogen announced that Samsung Biologics has now fully acquired Samsung Bioepis for a total consideration of USD…