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Sandoz’s Biosimilar Application Accepted - Big Molecule Watch

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…

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Expanding Operations in Biologics

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…

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International Trade Commission Institutes Investigation of Alvotech’s Adalimumab Biosimilar

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…

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Phase 1 Clinical Trial of Aflibercept (Eylea®) Biosimilar Completed by Alteogen

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…

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