Friday, July 26, 2013

Apotex get EU CHMP nod for fligrastim biosimilar for the treatment of neutropenia

On 25 July 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Grastofil, 30 MU/0.5 ml and 48 MU/0.5 ml, solution for injection or infusion intended for intended for the treatment of neutropenia. The applicant for this medicinal product is Apotex Europe B.V.
The active substance of Grastofil is filgrastim, an immunostimulating medicinal product (L03AA02) which regulates the production and release of functional neutrophils from the bone marrow.
Grastofil is a biological medicinal product similar to the reference product Neupogen authorised in the EU. Studies have shown Grastofil to have a comparable quality, safety and efficacy profile to Neupogen (filgrastim).

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