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…
Alvotech Holdings S.A. (“Alvotech”) announced today that it has resolved all intellectual property disputes with AbbVie in Europe related to Alvotech’s AVT02 (adalimumab) biosimilar candidate. This announcement follows Alvotech’s announcement last month that the company had settled its pending disputes related to AVT02 with AbbVie in the U.S., and states…
Shanghai Junshi Biosciences Co. Ltd. and Mabwell Bioscience Co. Ltd. announced that the jointly developed adalimumab biosimilar injection (Junmaikang ®) was officially approved by the Chinese National Medical Products Administration (NMPA) for marketing authorization (drug approval number: Sinopharm S20220008). Junmaikang® is used for the treatment of rheumatoid arthritis, ankylosing spondylitis,…
Results of the PROPER study, an interim analysis assessing the safety and efficacy of switching from Abbvie’s Humira to Samsung Bioepsis’s biosimilar adalimumab product, SB5, were presented last week at the European Crohn’s and Colitis Organization’s annual meeting. SB5 received EU marketing authorization in August 2017. According to the presentation, the…
As noted in our December 21, 2021 post, Complainants AbbVie Inc., AbbVie Biotechnology Ltd. and AbbVie Operations Singapore Pte. Ltd. filed a complaint at the International Trade Commission against Respondents Alvotech hf., Alvotech Germany GmbH, Alvotech Swiss AG, Alvotech USA Inc., Teva Pharmaceutical Industries Ltd., Teva Pharmaceuticals USA Inc., and…
On January 10, 2022, Alvotech Holdings S.A. (“Alvotech”) and JAMP Pharma Group (“JAMP Pharma”) announced that Health Canada granted marketing authorization to JAMP Pharma for a high-concentration biosimilar to Humira® (adalimumab) developed by Alvotech. The biosimilar, also referred to as AVT02, will be marketed in Canada as SIMLANDI (100 mg/mL…
According to various reports, Celltrion has received approval from Health Canada for YUFLYMA, a biosimilar of AbbVie’s HUMIRA product. YUFLYMA was previously approved in Europe, and is a high-concentration, low-volume, citrate-free formulation of adalimumab.
On November 25, 2021, Japan-based Mochida Pharmaceutical Co. announced that its adalimumab biosimilar, Adalimumab BS MA, had been launched in Japan following the listing of the drug on the National Health Insurance. According to the press release, Adalimumab BS MA is the first adalimumab biosimilar to Humira currently distributed in…
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Alvotech‘s high-concentration AVT02 (100 mg/mL), a proposed biosimilar to Humira® (adalimumab). Humira® is approved to treat certain inflammatory conditions. Róbert Wessman, Founder and Chairman of Alvotech, announced, “We are delighted by the CHMP’s…