On April 16, 2026, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in a patent dispute between Teva Pharmaceuticals (“Teva”) and Eli Lilly & Co. (“Lilly”). The case stems from a 2018 lawsuit in which
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.
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
As Goodwin’s PCAP discussed in a recent client alert, the staff (“Staff”) of the U.S. Securities and Exchange Commission (“SEC”) Division of Corporation Finance on March 13, 2026 published a no-action letter confirming that the Staff would not recommend
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
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
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
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
