Mylan NV (NASDAQ: MYL), a global pharmaceutical company, announced on Friday that it has started the commercial launch of Hulio, a biosimilar to AbbVie's Humira (adalimumab), across major markets in Europe.
The product is approved for all adalimumab indications and will be available to patients as soon as possible.
The European Commission approved the product in September 2018, following 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 Humira, an injectable, biologic medication that inhibits Tumour Necrosis Factor (TNF). The European Commission approval of the product is implemented to all 28 European Union member countries and European Economic Area member states of Norway, Iceland and Liechtenstein.
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