On November 13, 2025, the FDA approved Shanghai Henlius Biologics Co. Ltd.’s POHERDY (pertuzumab-dpzb) as an interchangeable biosimilar to Genentech’s PERJETA (pertuzumab). This is the first pertuzumab biosimilar to receive FDA approval. Pertuzumab is a HER2 inhibitor that is administered via an intravenous infusion with other agents and chemotherapies. POHERDY…
In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. The guidance, “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies Guidance…
Join Michael Siekman, Allegra Padula, and Riley Wyberg as they open our webinar series with “The BPCIA Has Changed How Companies Should Be Protecting Innovative Biologics and Biosimilars—Has Your Company Changed Its Strategy?” on November 18th at 2:00 PM EST. The data regarding which patents are being asserted over 10…
On November 6, 2025, Amgen, Inc. (“Amgen”) launched a new round of BPCIA denosumab litigations when it filed two cases in the U.S. District Court for the District of New Jersey, one against Dr. Reddy’s Laboratories (“Dr. Reddy’s”) and Alvotech, and the second against Amneal Pharmaceuticals (“Amneal”). As we previously…
On November 6, 2025, Hikma Pharmaceuticals PLC, and its subsidiary Hikma Pharmaceuticals USA Inc., announced the launch of STARJEMZA (ustekinumab-hmny). STARJEMZA references Janssen’s STELARA, and is indicated for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Craig Boyd, commercial lead for the biosimilar, commented that “We…
On November 3, 2025, Samsung Biologics announced the completion of the spin-off of its investment and subsidiary management business unit, and the establishment of Samsung Epis Holdings, an investment holding company that will oversee Samsung Bioepis and other future biotechnology subsidiaries. Samsung Biologics will continue to operate as a pure-play…
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®…