The EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for two ranibizumab biosimilars, VISLYFA and REXATILUX, recommending granting of a marketing authorization. Ranibizumab is a VEGF-A inhibitor, and can be used to treat macular degeneration via an intravitreal injection; the reference product, LUCENTIS, was…
As previously reported, litigation between Johnson & Johnson and Janssen (“J&J”) and Samsung Bioepis (“Samsung”) involving Samsung’s Stelara biosimilar, PYZCHIVA (ustekinumab-ttwe) (previously known as SB17), was resolved via a settlement agreement in 2023. Under the terms of the agreement, Samsung received a limited patent license, prohibiting Samsung from sublicensing with…
The U.S. Court of Appeals for the Third Circuit recently issued an opinion holding that when a district court has ordered discovery under 28 U.S.C. § 1782, but has not yet conclusively defined the scope of that discovery, the decision is not “final” and thus may not be appealed under…
Last week, Biocon Biologics Ltd (“BBL”) announced that the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) had issued positive opinions for Biocon’s two denosumab biosimilar candidates. The two candidates, VEVZUO and Denosumab BBL (the brand name is currently under approval), are each intended for distinct therapeutic indications. According…
This Monday, Bio-Thera Solutions and Dr. Reddy’s Laboratories SA announced that they had entered into commercialization and licensing agreements for proposed ustekinumab and golimumab biosimilars in Southeast Asia. Bio-Thera will develop, manufacture, and supply BAT2206 (the proposed ustekinumab biosimilar referencing Janssen’s STELARA) and BAT2506 (the proposed golimumab biosimilar referencing Janssen’s…
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…
As we previously reported, this August the European Commission granted approval for Celltrion’s STELARA biosimilar, STEQEYMA. Earlier this month, Celltrion launched STEQEYMA in both Germany and the Netherlands. Celltrion also plans to launch STEQEYMA in Finland in mid-November, and in Ireland later in the month. STEQEYMA is the third ustekinumab…
As we previously reported, REGENXBIO’s litigation against Sarepta, alleging infringement of U.S. Patent No. 11,680,274 (the “’274 patent”) by Sarepta’s gene therapy product, was stayed pending resolution of Sarepta’s IPR against the ’274 patent. The PTAB now has granted institution of Sarepta’s IPR, which challenges claims 1, 3-6, and 8…
This week, Biogen announced that the European Commission has approved TOFIDENCE, a tocilizumab biosimilar referencing Roche’s ROACTEMRA. TOFIDENCE was approved by the FDA in September 2023. TOFIDENCE is an intravenous formulation of an interleukin-6 receptor antagonist, and is approved for the treatment of moderate to severe active rheumatoid arthritis, polyarticular…
The USPTO recently issued a notice of proposed rulemaking regarding terminal disclaimers. The proposed rule would require that, for patents where a terminal disclaimer was filed to overcome obviousness-type double patenting, the patentee must agree that the patent on which the terminal disclaimer was filed will be enforceable only if…