On November 7, Vera Therapeutics announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) through the Accelerated Approval Program for atacicept for the treatment of adults with immunoglobulin A nephropathy (IgAN), a
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New FDA Guidance Aims to Simplify the Biosimilar Approval Process
In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein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:
FDA Approves Shanghai Henlius’s Interchangeable Pertuzumab Biosimilar
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
Register Today: Webinar Series: How the BPCIA Is Reshaping Biologics and Biosimilar Patenting Strategies
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.
Amgen Files BPCIA Complaints Against Dr. Reddy’s/Alvotech and Amneal Regarding Denosumab Biosimilars
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,
Samsung Biologics Completes Spin-Off and Launches Samsung Epis Holdings
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
Hikma Launches Ustekinumab Biosimilar STARJEMZA
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.
Prefilled Syringe Presentation of GSK’s SHINGRIX Receives Positive CHMP Opinion
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
Takeda and Innovent Biologics Enter Collaboration Agreement on IBI343 and IBI363 Cancer Drugs
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,
Recent Biologics Decisions at Health Canada
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).
