On March 18, 2024, Fresenius Kabi (“Fresenius”) and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada. The terms of the settlement are confidential. According to the press release, the settlement agreement aligns with Fresenius’s recent achievements in…
Genentech announced on February 16, 2024, that the U.S. Food and Drug Administration (FDA) approved XOLAIR (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with Immunoglobulin E (IgE)-mediated…
Regeneron Filed Complaint Against Amgen in C.D. Cal. Over ABP 938 Biosimilar to EYLEA On January 10, 2024, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Complaint in the U.S. District Court for the Central District of California against Amgen Inc. (“Amgen”) alleging infringement of 32 patents under the BPCIA based on Amgen’s…
On November 1, 2023, Fresenius Kabi announced the launch of its tocilizumab biosimilar TYENNE referencing ROACTEMRA (tocilizumab) in the European Union. TYENNE is the first tocilizumab biosimilar available in Europe for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and…
On June 16, 2023, Coherus BioSciences, Inc. and Surface Oncology, Inc. announced that they have entered into a definitive merger agreement, where, at the closing, Coherus will acquire Surface Oncology, a clinical-stage immuno-oncology (I-O) company developing next-generation immunotherapies that target the tumor microenvironment. Coherus’ Chairman and Chief Executive Officer said…
On May 4, 2023, Alvotech announced the initiation of a confirmatory patient study for AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab). The clinical study will compare the efficacy, safety, and immunogenicity of AVT05 and Simponi in adult patients with moderate to severe rheumatoid arthritis. Per the announcement,…
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…