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
On May 22, 2026, Polpharma Biologics announced that it had entered into an exclusive licensing agreement with Tuteur to commercialize a biosimilar targeting autoimmune diseases across Latin America, excluding Brazil. The parties did not disclose which specific biosimilar is covered
On May 29, 2026, Samsung Bioepis Co., Ltd. announced the European launch of OPUVIZ, a biosimilar referencing EYLEA (aflibercept). OPUVIZ will be available as a 40 mg/mL solution for injection.
Commenting on the launch, Antonio Rito, Vice President and Head
On May 26, 2026, Amneal Pharmaceuticals, Inc. and Kashiv Biosciences petitioned for inter partes review (IPR2026-00260) of all claims of U.S. Patent No. 12,030,959 (“the ’959 patent”), assigned to Novartis AG and Genentech, Inc. The ’959 patent is generally directed
On May 10, 2026, Shanghai Henlius Biotech announced that the FDA has approved its IND for a proposed biosimilar, HLX05-N, to Eli Lilly’s ERBITUX (cetuximab) product for the treatment of metastatic colorectal cancer (mCRC). ERBITUX is approved in the United
On May 15, 2026, the U.S. Food and Drug Administration (“FDA”) approved Accord BioPharma’s IMMGOLIS (golimumab-sldi) as an interchangeable biosimilar to Janssen’s SIMPONI® (golimumab), and IMMGOLIS INTRI (golimumab-sldi) as an interchangeable biosimilar to SIMPONI ARIA® (golimumab). IMMGOLIS and IMMGOLIS INTRI
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
As previously reported, litigation between Johnson & Johnson and Janssen (“J&J”) and Samsung Bioepis (“Samsung”) involving Samsung’s Stelara biosimilar, PYZCHIVA (ustekinumab-ttwe) (previously known as SB17), was resolved via a settlement agreement in 2023. Under the terms of the agreement,
