On October 21, 2025, GSK announced that the European Medicine Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted a positive opinion for the shingle vaccine SHINGRIX (recombinant zoster vaccine) in a prefilled syringe. SHINGRIX combines an antigen (glycoprotein E) with an adjuvant system (AS01B) to protect against…
In the last few weeks, Health Canada issued several decisions concerning biologics. On October 17, Health Canada approved, via a Notice of Compliance, Biocon Biologics Ltd.’s YESINTEK (ustekinumab injection) and YESINTEK I.V. (ustekinumab for injection, solution for intravenous infusion). YESINTEK and YESINTEK I.V. are biosimilars to Janssen Biotech, Inc.’s STELARA…
Last week, Takeda announced that it has entered into a worldwide license and collaboration agreement (outside of Greater China) with Innovent Biologics for the development, manufacture, and commercialization of two late-stage oncology medicines, IBI363 and IBI343. According to Takeda, IBI363, a PD-1/IL-2α-bias bispecific antibody fusion protein, is being evaluated in…
This week the FDA granted interchangeability status to Fresenius Kabi’s and Celltrion’s respective denosumab biosimilars. Interchangeable biosimilars can be substituted for the reference product at the pharmacy without intervention of the prescribing healthcare provider. On October 29, Fresenius Kabi announced that the FDA granted an interchangeability designation for CONEXXENCE® and BOMYNTRA®…
On October 20, 2025, the FDA approved Genentech’s GAZYVA® (obinutuzumab) as a treatment for adults with lupus nephritis (LN). Gazyva is a type II humanized anti-CD20 monoclonal antibody that works by targeting and eliminating certain B cells, which are believed to promote inflammation which causes kidney damage in LN. According…
On October 20, 2025, Teva Pharmaceuticals International GmbH (“Teva”) announced a licensing agreement with Prestige BioPharma Ltd. (“Prestige BioPharma”) to commercialize TUZNUE® (trastuzumab), a biosimilar to Genentech’s HERCEPTIN (trastuzumab), in a majority of European countries. Under the license and supply agreement, Teva obtained the rights to market and distribute TUZNUE®…
On October 17, Governor Newsom announced that California will be launching the “first and only” state contracted affordable insulin. Through an agreement with nonprofit generic drug manufacturer Civica Rx and Biocon Biologics, the interchangeable biosimilar insulin glargine pen CALRX will be available for purchase from January 1, 2026. The announcement…
As we have previously reported, on June 21, 2023, the FDA accepted Xbrane’s sBLA for LUCAMZI, a proposed ranibizumab biosimilar to Genentech’s LUCENTIS (ranibizumab). On October 16, 2025, Xbrane Biopharma AB announced that it has entered into a financing solution with Fenja Capital II A/S (Fenja) to proactively secure the…
On October 17, 2025, Amgen and AstraZeneca announced that the FDA has approved an additional indication for TEZSPIRE (tezepelumab-ekko) for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) in adult and pediatric patients aged 12 years and older. TEZSPIRE is the first biologic the FDA…
On October 9, 2025, the FDA approved Celltrion’s aflibercept biosimilar, EYDENZELT® (aflibercept-boav) referencing Regeneron’s EYLEA® (aflibercept). This approval makes Celltrion the sixth company to receive FDA approval for an aflibercept biosimilar, joining Biocon, Samsung Bioepis, Formycon, Sandoz, and Amgen. Aflibercept is a recombinant fusion protein that binds to vascular endothelial…