As we previously reported, portions of CareFirst’s antitrust claims concerning STELARA® (ustekinumab) survived summary judgment in December 2025. On January 14, 2026, the U.S. District Court for the Eastern District of Virginia reconsidered that decision and granted summary judgment to Johnson & Johnson and Janssen Biotech, Inc. (collectively, “J&J”) on…
On June 25, 2026, the U.S. Food and Drug Administration (FDA) announced the availability of revised draft guidance titled “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products.” The original draft guidance was issued in December 2019. When finalized, the revised draft guidance will replace the FDA’s 1998…
On July 1, 2026, Vertex Pharmaceuticals announced that the FDA approved an expanded indication for CASGEVY (exagamglogene autotemcel) to treat children aged two years and older with sickle cell disease (SCD) experiencing recurrent vaso-occlusive crises or who have transfusion-dependent beta thalassemia (TDT). The approval makes CASGEVY the first CRISPR-based gene-editing…
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 of Europe at Samsung Bioepis, stated: “We are pleased to…
On April 22, 2026 Amneal Pharmaceuticals, Inc. announced that it entered into an agreement to acquire Kashiv BioSciences, LLC. Under the terms of the agreement, Amneal will pay $375 million in cash and $375 million in equity at closing, along with up to $350 million in additional milestone and other…
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 Officer of Formycon AG stated of the announcement, “The agreement…
On February 11, 2026, Formycon AG and Lotus Pharmaceutical announced the execution of an exclusive license agreement directed to Formycon’s pembrolizumab biosimilar candidate, FYB206. Pembrolizumab is currently approved as KEYTRUDA (Merck Sharp & Dohme LLC) and is indicated to treat a variety of tumors. FYB206 is near the end of…
On December 4, 2025, the FDA approved a new indication for Bristol Myer Squibb’s BREYANZI (lisocabtagene maraleucel) for the treatment of adults with marginal zone lymphoma (MZL) who have failed treatment with or relapsed after two or more prior lines of therapy. BREYANZI is a chimeric antigen receptor T-cell (CAR…
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 September 29, 2025, Gedeon Richter Plc. (“Richter”) and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. (“Hikma”) announced that the FDA approved their biosimilar denosumab products Enoby and Xtrenbo (denosumab-qbde), referencing Prolia and Xgeva respectively. This marks the seventh biosimilar denosumab approval. Hikma and…