CHMP recommends Accofil for treatment of Neutropenia- a biosimilar version of Neupogen-Accord HealthCare
On 24 July 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Accofil, 30and 48 MU, solution for injection/infusion in pre-filled syringe intended for the treatment of Neutropenia. The applicant for this medicinal product is Accord Healthcare Ltd.
Accofil is a biological medicinal product similar to the reference product Neupogen authorised in the EU ( ie biosimilar). Studies have shown Accofil to have a comparable quality, safety and efficacy profile to Neupogen (filgrastim).
Learning Zones
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