On August 5, 2026, Moderna announced that the FDA approved mFLUSIVA (mRNA-1010), a new seasonal influenza vaccine, for use in all adults 50 years of age and older. As we previously reported, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted that the benefits of Moderna’s mRNA-1010 outweigh its…
On August 10, 2026, Amneal Pharmaceuticals, Inc. completed its acquisition of Kashiv BioSciences, LLC. According to Amneal, the acquisition results in “a fully integrated global biosimilars leader with end-to-end capabilities across research, development, manufacturing and commercialization,” and “establishes one of the industry’s few fully integrated biosimilars platforms.” Amneal’s Co-Founder and…
On June 25, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of revised draft guidance titled “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products.” The original draft guidance was issued in December 2019. When finalized, the revised draft guidance will replace the FDA’s 1998…
On August 1, 2026, Fresenius Kabi and Dr. Reddy’s Laboratories announced that the FDA had approved Dr. Reddy’s rituximab biosimilar, a biosimilar to Genentech’s RITUXAN® (rituximab). Rituximab is a monoclonal antibody that targets the CD20 antigen expressed on B lymphocytes and is used in the treatment of several B-cell malignancies,…
On July 29, 2026, the FDA announced that it had licensed EZPLAZ™ FDP, the first freeze-dried (lyophilized) plasma product to be licensed in the United States. The license was issued to Vascular Solutions LLC, a subsidiary of Teleflex Incorporated. EZPLAZ™ FDP is considered a biologic and is derived from…
On July 29, 2026, Genentech, Inc. (“Genentech”) and Hoffmann-La Roche Inc. filed a complaint in the U.S. District Court for the District of New Jersey against Biocon Biologics Inc. (“Biocon”) and related entities, alleging infringement of 28 patents relating to Genentech’s PERJETA and Biocon’s proposed biosimilar, Bmab1500. As we previously…
On July 30, 2026, Meitheal Pharmaceuticals, Inc. (“Meitheal”) announced that the U.S. Food and Drug Administration (“FDA”) has approved GARZULYS™ (insulin apsart-fsan) injection. GARZULYS™, a biosimilar to Novo Nordisk’s NOVOLOG® (insulin aspart), is a rapid-acting insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus and…
Celltrion has submitted a Marketing Authorization Application to the European Medicines Agency (“EMA”) for CT-P55, its biosimilar to Novartis’ COSENTYX® (secukinumab). The application covers all indications held by COSENTYX® in Europe, including plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, juvenile idiopathic arthritis, and hidradenitis suppurativa. According to Celltrion, CT-P55 has demonstrated…
On July 23, 2026, Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., announced the commercial launch of OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), FDA-approved interchangeable biosimilars to Amgen’s PROLIA® and XGEVA®, respectively. OSVYRTI® is indicated for the treatment of osteoporosis and bone loss related to hormone ablation therapy, while…
On July 24, 2026, Outlook Therapeutics, Inc. announced that the FDA approved LYTENAVA™ (bevacizumab-vikg) for the treatment of neovascular age-related macular degeneration (known as “nAMD” or “wet AMD”), marking the first FDA-approved ophthalmic formulation of bevacizumab in the United States. According to Outlook, bevacizumab has long been used off label…