On March 9, 2026, the U.S. Food and Drug Administration (FDA) issued new draft guidance aimed at further streamlining the development of biosimilar and interchangeable biosimilar products by reducing certain clinical pharmacokinetic (PK) study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 builds on an earlier FDA initiative announced in October that…
On February 20, 2026, the Federal Circuit held that patent claims directed to a cultured host cell are patent-eligible under 35 U.S.C. § 101—reversing a district court’s January 2024 decision granting summary judgment of patent ineligibility. The Federal Circuit decision makes clear that recombinant, human‑engineered host cells are patent‑eligible, even…
Dr. Reddy’s Laboratories (“Dr. Reddy’s”) announced on February 22 that the FDA accepted its BLA for DRL_AB, a proposed interchangeable biosimilar to Bristol-Myers Squibb’s ORENCIA® (abatacept) IV for infusion. According to the press release, abatacept works as a selective co-stimulation modulator and functions by binding to specific proteins on immune…
On March 3, Janssen Biotech, Inc. and Janssen Sciences Ireland UC (collectively, “Janssen”) filed a BPCIA complaint in the U.S. District Court for the District of Delaware against Accord BioPharma, Inc. and Bio-Thera Solutions, Ltd., alleging that Accord and Bio-Thera infringe 17 patents in relation to their proposed golimumab biosimilar. …
On February 27, 2026, Genentech filed a Section 337 complaint at the U.S. International Trade Commission (ITC) targeting Biocon’s proposed pertuzumab biosimilar, BMAB 1500/PERT-IJS, which references Genentech’s PERJETA®. The complaint, captioned Certain Pertuzumab Biosimilars, Including Those Made by Certain Methods of Manufacturing, the Active Ingredient Thereof, and Products Containing the…
On February 13, 2026, STADA and Bio-Thera announced that they have received European Marketing Authorization for GOTENFIA®, a golimumab biosimilar to Johnson & Johnson’s SIMPONI®. GOTENFIA® is a human monoclonal antibody that targets tumor necrosis factor-alpha (TNF-α), a key driver of inflammation in multiple autoimmune conditions. GOTENFIA® has been approved in…
On February 17, 2026, the U.S. Food and Drug Administration (FDA) approved FILKRI (filgrastim-laha), a biosimilar to Amgen’s NEUPOGEN (filgrastim). FILKRI was developed by Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals Ltd. FILKRI is indicated for patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia (AML)…
On February 10, 2026, the World Health Organization (“WHO”) prequalified a new novel oral polio vaccine type 2 (“nOPV2”) product. The newly prequalified product will be manufactured by Biological E. Limited, India using in-house bulk vaccine technology transferred from PT Bio Farma (Persero), Indonesia. WHO has previously prequalified nOPV2 products…
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 February 11, 2026, Samsung Bioepis, Co., Ltd (“Samsung”) and Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed a Joint Stipulation and Proposed Order seeking to dismiss all claims and counterclaims without prejudice and to vacate the preliminary injunction previously entered against Samsung. According to Regeneron, the parties entered into a settlement agreement…