EMA publishes draft biosimilar guideline for interferon beta

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EMA publishes draft biosimilar guideline for interferon beta

INICIO/Directrices | Posted 27/01/2012 0 Post your comment

EMA announced on 20 January 2012 that it has published a draft guideline on how pharmaceutical companies should test biosimilar medicines containing interferon beta. The draft guideline is released for a four-month public consultation period. Feedback on the draft guideline can be submitted to EMA until the end of May 2012.

Interferon beta-containing medicines are used to treat patients with multiple sclerosis (MS) and are currently indicated for patients with relapsing MS or at high risk of developing MS after a single demyelinating event.

Three different medicinal products containing recombinant interferon beta are currently approved in the EU for first-line treatment of MS, they differ with respect to their molecular structure, injection route, recommended posology and MS indications.

The clinical effects of recombinant interferon beta in relapsing MS are modest with decreases in the frequency of exacerbations by approximately 30% compared with placebo and inconsistent results on the progression of disability.

The proposed guideline lays down the non-clinical and clinical requirements for biosimilars containing interferon beta and claiming to be similar to an interferon beta which is already marketed. The non-clinical section addresses the pharmaco-toxicological requirements and the clinical section the requirements for pharmacokinetic, pharmacodynamic, efficacy and safety studies as well as pharmacovigilance aspects.

Guideline on similar biological medicinal products containing interferon beta
EMA/CHMP/BMWP/652000/2010
Draft agreed by BMWP: October 2011
Adoption by CHMP for release for consultation: 15 December 2011
End of consultation (deadline for comments): 31 May 2012
www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/01/WC500120652.pdf

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Source: EMA