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 July 30, 2025, Moderna announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted that the benefits of Moderna’s investigational mRNA influenza vaccine, mRNA-1010 (proposed brand name mFlusiva), outweigh its risks for adults ages 50 to 64 and adults ages 65 and older. mRNA-1010 is…
On June 5, Lupin announced that the U.S. Food and Drug Administration (“FDA”) approved RANLUSPEC, a ranibizumab biosimilar to Genentech’s LUCENTIS®. RANLUSPEC, which received European Marketing Authorization earlier this year, is indicated for the treatment of neovascular (wet) age-related macular degeneration and other retinal vascular disorders. It is the only…
On June 8, Alvotech announced that the U.S. Food and Drug Administration (“FDA”) has accepted Alvotech’s Biologics License Application (“BLA”) for AVT16, a proposed interchangeable biosimilar to Takeda’s ENTYVIO (vedolizumab), for review. ENTYVIO is a humanized monoclonal antibody approved for the treatment of adults with moderately to several active ulcerative…
On May 29, 2026, Boan Biotech announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for BA6101 (denosumab; injection 60 mg) and BA1102 (denosumab; injection 120 mg), referencing Amgen’s PROLIA® (denosumab) and XGEVA® (denosumab), respectively. According to Boan Biotech, the submission is…
On April 21, 2026, Biocon announced that Health Canada granted a Notice of Compliance (NOC) for BOSAYATM (denosumab) and VEVZUOTM (denosumab), biosimilars of Amgen’s Prolia® (denosumab) and Xgeva® (denosumab). Denosumab is a human monoclonal antibody that targets and binds to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). In Canada,…
On May 4, 2026, the FDA approved Lannett Company, Inc. (“Lannett”), Lanexa Biologics LLC (“Lanexa”), and Sunshine Lake Pharma’s LANGLARA (insulin glargine-aldy) as an interchangeable biosimilar to Sanofi’s LANTUS (insulin glargine). LANGLARA is approved for the treatment of adults and pediatric patients with type 1 diabetes mellitus and adults with…
On April 14, 2026, the United States Food and Drug Administration (“FDA”) issued a draft guidance for sponsors seeking approval of human gene-editing therapy products involving gene-editing technologies. The guidance provides recommendations for assessing the safety of genome-editing therapies to bring effective treatments to patients. The guidance includes considerations for…
The U.S. Food and Drug Administration (“FDA”) recently released its congressional justification for the 2027 Fiscal Year budget. Overall, the FDA proposed a total budget of $7.2 billion, an overall increase of 3.3% above the 2026 Fiscal Year enacted level. As part of the legislative proposals, the FDA included a…