On April 7, 2025, Teva Pharmaceuticals and Samsung Bioepis Co., Ltd. announced the U.S. launch of EPYSQLI® (eculizumab-aagh), a biosimilar referencing Alexion Pharmaceuticals’ SOLIRIS®. As we reported in January, Teva and Samsung Bioepis entered into a strategic partnership regarding EPYSQLI®, with Samsung Bioepis handling development, manufacturing, and supply and Teva…
On March 12, 2025, Celltrion announced the commercial launch of STEQEYMA® (ustekinumab-stba), a biosimilar of Janssen’s STELARA® (ustekinumab), in the United States. As we previously reported, the biosimilar was approved by the FDA in December 2024 for subcutaneous injection or intravenous infusion in adult and pediatric patients for treatment of…
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions recommending the grant of marketing authorizations for three biosimilar products—Amgen’s PAVBLU and SKOJOY, and CuraTeQ Biologics’ DYRUPEG. Amgen’s PAVBLU and SKOJOY, both biosimilars referencing EYLEA…
On July 22, 2024, STADA Arzeimittel AG (“STADA”) and Alvotech announced the launch of ustekinumab biosimilar AVT04 under the name UZPROVO® across a majority of European countries. UZPROVO®, the first approved ustekinumab biosimilar to STELARA® in Europe, is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis. As…
On May 20, 2024, Teva Pharmaceuticals (“Teva”) and Alvotech announced the availability of SIMLANDI (adalimumab-ryvk) injection in the United States, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis….
On April 15, 2024, Fresenius Kabi announced the U.S. launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation. As we previously reported, Fresenius Kabi received FDA approval for both intravenous and subcutaneous formulations on March 5, 2024, making TYENNE the first tocilizumab biosimilar approved in both formulations. TYENNE is…
On February 15, Alvotech announced that it reached more settlement agreements with Johnson & Johnson for ATV04, Alvotech’s biosimilar to STELARA (ustekinumab). The settlements cover Canada, the European Economic Area, and Japan, clearing the way for Alvotech to launch AVT04 in those markets, where AVT04 has already received regulatory approval. …
On January 17, 2024, Celltrion announced the U.S. launch of a new, 80 mg/0.8 ml dosage strength of its HUMIRA® biosimilar, YUFLYMA® (adalimumab-aaty). As we previously reported, Celltrion received FDA approval for an 80 mg/0.8 ml dose and a 20 mg/0.2 ml dose on October 4, 2023. Celltrion’s January 2024…
On November 1, 2023, Fresenius Kabi announced the launch of its tocilizumab biosimilar TYENNE referencing ROACTEMRA (tocilizumab) in the European Union. TYENNE is the first tocilizumab biosimilar available in Europe for the treatment of several inflammatory and immune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and…