On January 3, 2023, Samsung Bioepis announced that Health Canada has approved their citrate-free, high concentration (40 mg/0.4 mL) HUMIRA biosimilar, HADLIMA (also known as SB5). HADLIMA is indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis, ankylosing spondylitis (AS), psoriatic arthritis, adult Crohn’s disease, ulcerative colitis,…
Earlier today, Fresenius Kabi announced that the U.S. Food and Drug Administration (FDA) approved IDACIO (adalimumab-aacf), a biosimilar referencing HUMIRA. IDACIO is approved for use in the treatment of chronic autoimmune diseases for all eligible indications of the reference product and, according to Fresenius, is expected to launch in the…
Alvotech announced yesterday the launch of HUKYNDRA, a high-concentration, low-volume, citrate-free biosimilar to HUMIRA (adalimumab), in Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia. Through a strategic partnership with STADA, Alvotech supplies HUKYNDRA (adalimumab) autoinjectors and pre-filled syringes with drug product and drug substance manufactured in its vertically integrated…
As we previously reported, Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) announced its intent to acquire the global biosimilars business of its long-term partner Viatris, Inc. This week, Biocon confirmed completion of its acquisition in a part-cash/part-equity transaction. Under the terms of this USD $3.335 billion deal, Biocon paid…
Last week, AbbVie held its third quarter 2022 earnings conference call, which included considerable discussion of forthcoming competition with biosimilars to HUMIRA (adalimumab) in 2023. Some highlights below: According to Rick Gonzalez, AbbVie Chairman and CEO, “[t]he current market dynamics do not change our long-term guidance for aesthetics and we…
Last week Samsung Bioepis and Organon announced FDA approval of their citrate-free, high-concentration (100 mg/ml) HUMIRA biosimilar, HADLIMA (adalimumab-bwwd). HADLIMA was previously approved by FDA as a low concentration (50 mg/ml) formulation in July 2019. The low-concentration product has been available in various markets outside the United States, with over…
The Big Molecule Watch is monitoring clinical trial activities involving adalimumab. Here we report on three recent studies with adalimumab biosimilars for treating psoriasis, inflammatory bowel disease, Crohn’s disease and ulcerative colitis. In July 2022, clinical trial data was published from a real-life retrospective observational study of pediatric (<18 years)…
As reported by Pulse and DailyPharm Korea, Celltrion recently filed an Investigational New Drug (IND) application with the FDA for a global Phase 3 clinical trial aimed at demonstrating its biosimilar’s (YUFLYMA) interchangeability with HUMIRA (adalimumab). The trial will evaluate the pharmacokinetics, efficacy, and safety of YUFLYMA in 366 patients with plaque psoriasis….
Alvotech, a global biotech company focused solely on the development and manufacture of biosimilar medicines announced yesterday that its ordinary shares and warrants will begin trading on Nasdaq today, June 16, under the new ticker symbols “ALVO” and “ALVOW”, respectively. The debut on Nasdaq follows completion of the company’s business…
Celltrion recently announced that it will start selling Yuflyma, an adalimumab biosimilar, in the U.S. in July 2023. The announcement stems from Celltrion’s recently inked patent agreement with AbbVie which allows Celltrion to market a high-concentration formulation of the drug. As a company official stated, “By entering the U.S. market…