The U.S. Food and Drug Administration (“FDA”) recently released its congressional justification for the 2027 Fiscal Year budget. Overall, the FDA proposed a total budget of $7.2 billion, an overall increase of 3.3% above the 2026 Fiscal Year enacted level. As part of the legislative proposals, the FDA included a…
On April 7, 2026, Biocon Limited announced that it had launched BOSAYA™ (denosumab-kyqq) and AUKELSO™ (denosumab-kyqq) in the United States. Both products are RANK ligand inhibitors used to treat conditions such as osteoporosis and cancer-related skeletal complications. BOSAYA™ and AUKELSO™ have been designated as interchangeable with their corresponding reference products,…
On March 26, 2026, the U.S. Food and Drug Administration approved Rocket Pharmaceuticals’ Kresladi (marnetegragene autotemcel), the first gene therapy treatment for pediatric patients with severe Leukocyte Adhesion Deficiency Type I (LAD-I). LAD-I is an inherited immune deficiency cause by mutations in the ITGB2 gene that leaves patients susceptible to…
On April 2, 2026, Regeneron Pharmaceuticals announced that the U.S. Food and Drug Administration has approved an extension to the dosing intervals for EYLEA HD (aflibercept) patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The approval increases the maximum dosing interval from 16 weeks to 20…
On March 30, 2026, Teva Pharmaceutical Industries Ltd. (“Teva”) announced that the U.S. Food and Drug Administration (“FDA”) has approved its denosumab biosimilar, PONLIMSI™ (denosumab-adet). PONLIMSI™ has been approved for all indications of the reference product, Amgen’s PROLIA®, including the treatment of osteoporosis in postmenopausal women at high risk for…
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 settlement between the parties. Under the consent judgment, Henlius and…
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 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 by Janssen Biotech, Inc. (“Janssen”), a subsidiary of Johnson &…
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 biosimilar commercialization partnership focused on India. Golimumab is a human…
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® becomes one of the first tocilizumab biosimilars to have both…