On July 23, 2026, Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., announced the commercial launch of OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), FDA-approved interchangeable biosimilars to Amgen’s PROLIA® and XGEVA®, respectively. OSVYRTI® is indicated for the treatment of osteoporosis and bone loss related to hormone ablation therapy, while…
On July 9, 2026, Accord BioPharma announced that the FDA approved ENNUMO (pegfilgrastim-pccg). ENNUMO references Amgen’s NEULASTA (pegfilgrastim). The FDA approved ENNUMO on May 7, 2026, for the same indications as NEULASTA: for adult and pediatric patients, to decrease the incidence of infections, as manifested by febrile neutropenia, in patients…
On May 15, 2026, the U.S. Food and Drug Administration (“FDA”) approved Accord BioPharma’s IMMGOLIS™ (golimumab-sldi) as an interchangeable biosimilar to Janssen’s SIMPONI® (golimumab), and IMMGOLIS INTRI™ (golimumab-sldi) as an interchangeable biosimilar to SIMPONI ARIA® (golimumab). IMMGOLIS and IMMGOLIS INTRI are the first biosimilars approved for SIMPONI and SIMPONI ARIA….
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 &…
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, “Defendants”), alleging that Accord and Bio-Thera infringe 17 patents in…
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. …
This past year contained a number of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top three legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Start to Resolve As in 2023 and 2024, Regeneron’s multi-district…
On November 20, 2025, the FDA approved Accord BioPharma’s denosumab biosimilars OSVYRTI® (denosumab-desu) and JUBEREQ® (denosumab-desu), which reference Amgen’s PROLIA® and XGEVA®, respectively. This marks the eighth set of denosumab biosimilars approved by the FDA. Both OSVYRTI® and JUBEREQ® are approved for all indications of their respective reference products. Denosumab is a…
On August 18, 2025, Accord BioPharma, Inc. (“Accord BioPharma”) announced the commercial launch of IMULDOSA® (ustekinumab-srlf), a biosimilar to STELARA® (ustekinumab) in the United States. IMULDOSA® is supplied as single-dose prefilled syringes for subcutaneous use in 45 mg/0.5 mL and 90 mg/mL strengths or as a single-dose vial for intravenous…
On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing Johnson & Johnson’s (“J&J”) SIMPONI®. Golimumab is a human IgG1 monoclonal antibody that blocks the inflammatory effects of tumor necrosis…