On October 13, 2026, Formycon and Zydus announced that the FDA accepted for review the Biologics License Application for FYB206, a proposed biosimilar to Merck’s KEYTRUDA® (pembrolizumab). This is the first publicly announced FDA acceptance of an application for a proposed KEYTRUDA® biosimilar. Formycon also submitted the regulatory dossier to…
On October 13, 2026, the FDA announced the availability of a final guidance for industry entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers,” finalizing a previously issued draft guidance of the same title issued on July 23, 2024. The FDA issued the guidance pursuant to…
On August 18, 2026, Biocon Ltd. (“Biocon”) announced that its U.S. subsidiary has received supplemental U.S. FDA approval for YESINTEK® (ustekinumab-kfce) in a single-dose prefilled autoinjector, 45 mg/0.5 mL and 90 mg/mL. YESINTEK® was originally approved by the FDA on November 29, 2024, in 45 mg/0.5 mL or 90 mg/mL…
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 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 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…
On June 30, 2026, the U.S. Department of Health and Human Services (HHS) announced that COVID-19 Emergency Use Authorization (EUA) declarations will terminate on December 26, 2026, for medical devices and on June 29, 2027, for drugs and biological products. The declarations were established to facilitate access to unapproved medical…
On June 30, 2026, Orca Bio announced that the U.S. Food and Drug Administration (“FDA”) approved TREGZI™ for use in matched donor hematopoietic stem cell transplantation with myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host-free survival, in the treatment of adults with hematological malignancies. TREGZI™…
On July 1, 2026, Celltrion announced that the FDA had granted interchangeability designation to TRUXIMA® (rituximab-abbs), Celltrion and Teva’s biosimilar to Genentech’s RITUXAN®. With this designation, TRUXIMA® became the first rituximab biosimilar to receive interchangeable status in the United States. TRUXIMA®, originally approved by FDA in November 2018, is approved…
On June 10, 2026, Organon announced that the U.S. Food and Drug Administration (FDA) approved a supplemental biologics license application (sBLA) for TOFIDENCE ® (tocilizumab-bavi), an intravenous biosimilar to Genentech’s ACTEMRA® (tocilizumab). The approval expands TOFIDENCE’s indications to include: (1) adults and pediatric patients (2 years of age and older)…