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 &…
On August 21, 2025, Alvotech and Advanz Pharma Holdco Limited (“Advanz”) announced that MYNZEPLI®, a biosimilar of Regeneron’s EYLEA® (aflibercept), was approved by the European Commission. MYNZEPLI® will be available as a 40 mg/mL solution in a pre-filled syringe and vial and is approved for the same adult indications as…
On February 10, 2025, Bio-Thera Solutions, Ltd. announced that they entered into an exclusive licensing agreement with Intas Pharmaceuticals Ltd. to commercialize BAT2506 (golimumab), Bio-Thera’s proposed biosimilar of SIMPONI®, in the United States. According to the agreement, Bio-Thera will maintain responsibility for the development, manufacturing, and supply of BAT2506, while…
On Dec 24, 2024, Bio-Thera Solutions Inc. announced that it has partnered with Tabuk Pharmaceutical Manufacturing Company to commercialize BAT2206, a proposed ustekinumab biosimilar to Jansen’s STELARA, in Saudi Arabia. According to the partnership agreement, Tabuk will hold the marketing authorization and be responsible to manufacture, register, import, and market…
This Monday, Bio-Thera Solutions announced that it would be expanding its Latin American biosimilar marketing partnership with SteinCares. Previously, Bio-Thera and SteinCares had agreed to a partnership whereby Bio-Thera, a commercial-stage biopharmaceutical company, granted SteinCares, a Latin American specialty healthcare company, exclusive rights to market two of Bio-Thera’s biosimilars in…
On October 9, 2024, Bio-Thera Solutions and Gedeon Richter announced they have reached an exclusive commercialization and license agreement for BAT2206, a biosimilar candidate to STELARA (ustekinumab). Under the agreement, Bio-Thera will be responsible for development, manufacturing, and supply of BAT2206, and Richter will have exclusive rights to commercialize the…
In the past few weeks, the European Commission provided marketing authorization for biosimilars of denosumab and omalizumab, as well as an ophthalmic formulation of bevacizumab. On May 22, Sandoz announced that it received marketing authorization from the European Commission for its WYOST® and JUBBONTI® denosumab biosimilars. According to Sandoz, these…
On December 7, 2023, Bio-Thera Solutions, Ltd. announced that the FDA has approved AVZIVI (bevacizumab-tnjn), a biosimilar referencing Genentech’s AVASTIN. AVZIZI is the fifth bevacizumab biosimilar approved by the FDA, behind Amgen’s MVASI (bevacizumab-awwb), approved in September 2017; Pfizer’s ZIRABEV (bevacizumab-bvzr), approved in June 2019; Amneal’s ALYMSYS (bevacizumab-maly), approved in…
As we previously reported, in July 2023 Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (collectively, “Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts, asserting that Biogen sought FDA approval “to commercialize ‘BIIB800,’ a proposed biosimilar to Genentech’s drug Actemra®…