On March 31, 2026, the District Court for the District of New Jersey entered a Consent Order and Judgment in the BPCIA litigation Amgen brought against Henlius and Organon concerning their denosumab biosimilars, BILPREVDA® (denosumab‑nxxp) and BILDYOS® (denosumab‑nxxp), following a
On March 19, 2026, Formycon and its license partner Klinge Biopharma announced a settlement and license agreement with Regeneron and Bayer resolving all patent disputes relating to the EU-approved AHZANTIVE and BAIAMA aflibercept biosimilars referencing EYLEA. Nicola Mikulcik, Chief Business
On March 20, 2026, Accord BioPharma, Inc. (“Accord”), Intas Pharmaceuticals Ltd. (“Intas”), and Bio-Thera Solutions, Ltd. (“Bio-Thera,” collectively “Petitioners”) filed four Inter Partes Review petitions (“IPRs”) challenging four patents directed to methods of treatment using golimumab. The four patents are owned
On March 23, 2026, Bio-Thera Solutions announced an expansion of its existing partnership with Intas Pharmaceuticals for BAT2506, its golimumab biosimilar referencing Janssen’s SIMPONI®. The updated agreement grants Intas exclusive commercialization and licensing rights in India and marks Bio-Thera’s first
On March 16, 2026, Celltrion, Inc. announced the U.S. commercial launch of AVTOZMA® (tocilizumab-anoh) SC, a subcutaneous formulation of its tocilizumab biosimilar referencing Roche’s ACTEMRA. Celltrion had previously launched its intravenous AVTOZMA® in October 2025. With this new launch, AVTOZMA®
On March 18, 2026, Sandoz announced a new license, development, and commercialization partnership agreement with Samsung Bioepis Co., Ltd. Under this agreement, the companies will collaborate on the development and commercialization of up to five biosimilar assets, with the potential
As we reported last week, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed under seal a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd. (collectively,
Johnson & Johnson announced on March 5, 2026 that the U.S. Food and Drug Administration (FDA) approved TECVAYLI® (teclistamab-cqyv) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received
On March 9, 2026, the U.S. Food and Drug Administration (FDA) issued new draft guidance aimed at further streamlining the development of biosimilar and interchangeable biosimilar products by reducing certain clinical pharmacokinetic (PK) study requirements when scientifically justified. The announcement
