On September 17, 2025, Alvotech USA Inc. and Alvotech hf. (“Alvotech”) filed a Petition for Post Grant Review of U.S. Patent No. 12,168,036 (“the ‘036 patent”), assigned to Regeneron Pharmaceuticals, Inc. (“Regeneron”). The ‘036 patent, entitled “Methods for treating angiogenic eye disorders with high doses of VEGF receptor fusion proteins,”…
On August 21, 2025, Alvotech and Advanz Pharma Holdco Limited (“Advanz”) announced that MYNZEPLI®, a biosimilar of Regeneron’s EYLEA® (aflibercept), was approved by the European Commission. MYNZEPLI® will be available as a 40 mg/mL solution in a pre-filled syringe and vial and is approved for the same adult indications as…
On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing Johnson & Johnson’s (“J&J”) SIMPONI®. Golimumab is a human IgG1 monoclonal antibody that blocks the inflammatory effects of tumor necrosis…
On June 25, 2025, Kashiv BioSciences announced positive topline results from its confirmatory Phase 3 trial of ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), in patients with chronic spontaneous urticaria. The study met both primary and secondary endpoints, demonstrating therapeutic equivalence and comparable safety to the reference product. ADL-018, developed…
On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe. Samsung Bioepis announced a licensing, development, and commercialization agreement with NIPRO Corporation for multiple biosimilar candidates in Japan. One of these candidates is SB17, a biosimilar of Janssen’s…
GLOBAL BIOSIMILAR UPDATES Celltrion Bolsters Biosimilars Market Position in Italy Celltrion’s ustekinumab biosimilar, STEQEYMA®, has won its first bid within 2 months of its launch in January of 2025. Since launch, STEQEYMA® has secured contracts in four regions of Italy, including, Piemonte, Valle d’Aosta, Liguria, and Sardegna. Combined, these contracts…
On March 18, 2025, Alvotech and Dr. Reddy’s announced that the FDA accepted their Biologics Licensing Application (BLA) for AVT03 (denosumab), referencing Amgen’s PROLIA® and XGEVA®. After FDA approval, Alvotech and Dr. Reddy’s expect AVT03 to be supplied in a single-dose prefilled syringe containing 60 mg in a 1 mL…
On February 18, 2025, Alvotech and Teva Pharmaceuticals (“Teva”) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT06, a proposed biosimilar to EYLEA® 2 milligram (mg). AVT06 is an aflibercept biosimilar candidate for the treatment of eye disorders such…
On January 27, 2025, Alvotech and Teva announced FDA acceptance of Biologics License Applications (BLAs) for AVT05, a proposed biosimilar to SIMPONI and SIMPONI ARIA. SIMPONI and SIMPONI ARIA contain golimumab, an anti-TNF therapy for inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. This marks the first U.S. BLA acceptance…
As 2025 begins, we would like to reflect on last year’s regulatory developments in the biologics and biosimilars space. Here are some of the top regulatory developments from 2024. 1. FDA Approvals in 2024 There were 17 FDA approvals of Biologic License Applications (“BLAs”), including for Autolus Inc.’s AUCATZYL…