On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and only interchangeable biosimilar to Novo Nordisk’s NOVOLOG (insulin aspart injection) in the United States. KIRSTY is…
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 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 January 27, 2025, Alvotech and Teva announced FDA acceptance of Biologics License Applications (BLAs) for AVT05, a proposed biosimilar to SIMPONI and SIMPONI ARIA. SIMPONI and SIMPONI ARIA contain golimumab, an anti-TNF therapy for inflammatory conditions including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. This marks the first U.S. BLA acceptance…
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…
On November 25, 2024, Intellia Therapeutics announced that its CRISPR-based therapy, nexiguran ziclumeran (nex-z, NTLA-2001), received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for treatment of hereditary transthyretin (ATTR) amyloidosis with polyneuropathy (ATTRv-PN). Nex-z is an in vivo gene editing therapy designed as a single-dose treatment to inactivate…
On October 30, 2024, Shanghai Henlius Biotech and Organon announced that the FDA has accepted the Biologic License Application (BLA) for HLX14, a proposed biosimilar to PROLIA/XGEVA (denosumab). In 2022, Shanghai Henlius Biotech granted Organon exclusive commercialization rights for HLX14 in the U.S., EU, and Canada. The filing for HLX14…
In the last few weeks, the PTAB has granted institution of eight IPRs filed by Merck on Johns Hopkins patents directed to methods of treatment using pembrolizumab. The eight patents are generally directed to methods for treating cancer in a patient having a tumor that exhibits a high microsatellite instability…
On September 17, Express Scripts, Inc. (“Express Scripts”), one of the largest pharmacy benefit managers (PBMs) in the United States, brought suit against the Federal Trade Commission (“FTC”) over its July 2024 interim report on the PBM industry. Express Scripts claims that the FTC’s report, titled “Pharmacy Benefit Managers: The Powerful…
Approval of Celltrion’s Ustekinumab Biosimilar in the EU: On August 26, 2024, Celltrion announced that the European Commission (EC) granted approval for STEQEYMA, formerly known as CT-P43, a biosimilar of STELARA (ustekinumab), for the treatment of several chronic inflammatory conditions. STEQEYMA is a human IL-12 and IL-23 antagonist indicated for…