On July 16, 2025, the District Court for the District of New Jersey entered a Consent Judgment and Injunction in view of a settlement agreement between Amgen, Inc. (“Amgen”) and Accord BioPharma, Inc. (“Accord”) resolving the BPCIA litigation regarding Accord’s denosumab biosimilar, INTP23. Pursuant to the agreement, Accord will be…
On July 9, 2025, Lupin Limited and Zentiva Group announced a license and supply agreement to commercialize Lupin’s biosimilar of Certolizumab Pegol across multiple global markets. Under the agreement, Lupin will lead development, manufacturing, and supply of the biosimilar. Zentiva will handle commercialization in the Europe and CIS markets, leveraging…
On June 2, 2025, Sandoz announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are now available to patients in the United States. WYOST® and Jubbonti® are the first and only interchangeable FDA-approved denosumab biosimilars and are approved to treat all indications of the reference medicines, XGEVA® and Prolia®. The FDA approved WYOST®…
In its June 2025 meeting, the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted positive opinions for six biosimilar medicines. The medicines include four aflibercept products (Mynzepli, Afiveg, Vgenfli and Eiyzey), one ustekinumab product (Usymro), and one pegfilgrastim product (Vivlipeg). Additionally, on June 23, 2025, Alvotech announced that…
In the last week, Amgen, Inc and Amgen Manufacturing Ltd, LLC (“Amgen”) filed three more BPCIA complaints against companies seeking approval for a denosumab biosimilar. On June 25, 2025, Amgen filed a complaint in the U.S. District Court for the District of New Jersey against Hikma Pharmaceuticals USA Inc. (“Hikma”),…
On June 25, 2025, Kashiv BioSciences announced positive topline results from its confirmatory Phase 3 trial of ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), in patients with chronic spontaneous urticaria. The study met both primary and secondary endpoints, demonstrating therapeutic equivalence and comparable safety to the reference product. ADL-018, developed…
On June 12, 2025, BioNTech SE (“BioNTech”) announced its entry into a definitive purchase agreement to acquire all shares of CureVac N.V. (“CureVac”), with an implied aggregate equity value for CureVac of approximately $1.25 billion. The acquisition “aims to strengthen the research, development, manufacturing, and commercialization of [BioNTech’s] investigational mRNA-based…
Teva Pharmaceutical Industries Ltd. (“Teva”) and Shanghai Fosun Pharmaceutical (Group) Co. (“Fosun Pharma”) recently announced a partnership to accelerate the development of Teva’s TEV-56278, a novel fusion protein that uses Teva’s ATTENUKINE™ technology to target cytokine activity to tumor cells while reducing toxic side effects. The new drug is intended…
On June 15, 2025, Celltrion announced that the FDA has approved a new 45mg/0.5mL single-dose vial presentation of STEQEYMA (ustekinumab-stba) for subcutaneous injection. The formulation is intended for pediatric patients (ages 6–17) under 60kg with plaque psoriasis (PsO) or psoriatic arthritis (PsA). With this approval, STEQEYMA now matches all dosage…
On June 17, 2025, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed another complaint against Amgen Inc. (“Amgen”) under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU®, infringes U.S. Patent No. 12,331,099 (“the ’099 patent”). The ’099 patent issued on the same day, with claims generally directed to a stable liquid ophthalmic formulation…