Sandoz recently announced that the EMA (European Medicines Agency) has accepted its application for a 100 mg/ml citrate-free formulation of its biosimilar HYRIMOZ® (adalimumab). The indications covered in the application include rheumatoid arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and uveitis. According to the press release, Sandoz has conducted a…
Catalent and Abzena both recently announced substantial investments into new biologics facilities. Catalent is spending up to $160 million to build a new manufacturing facility near Oxford, UK. Catalent plans to equip the facility with “state-of-the-art capabilities for the development and manufacture of biologic therapies and vaccines, including mRNA, proteins…
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…
Alteogen recently announced that it has successfully completed a Phase 1 clinical trial for its Eylea® biosimilar, ALT-L9. Alteogen conducted the clinical trials in South Korea, where its headquarters are located. In the clinical trials, ALT-L9 and Eylea® were randomly assigned to 28 patients with neovascular (wet) age-related macular degeneration (wet…