Mylan (MYL) and Fujifilm Kyowa Kirin Biologics announced that the European Commission has granted marketing authorization for Hulio, a biosimilar to AbbVie’s (ABBV) Humira – adalimumab -, for all indications. The authorization follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use, which concluded that the development program including analytical, functional, clinical and immunogenicity data demonstrated biosimilarity with the reference product, Humira. The EC approval of Hulio applies to all 28 European Union member countries and European Economic Area member states of Norway, Iceland and Liechtenstein. Mylan plans to launch Hulio across various markets in Europe on or after Oct. 16. Mylan and Fujifilm Kyowa Kirin Biologics partnered earlier this year. Fujifilm Kyowa Kirin Biologics has a nonexclusive royalty bearing license with AbbVie for the use and sale of Hulio in European countries. Humira had brand sales of approximately $4.4B in Europe for the 12 months ending June 30, 2018.
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