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EMA launches consultation on biosimilar tests of interferon beta

Covers non-clinical and clinical requirements for versions of the multiple sclerosis drugs

The European Medicines Agency (EMA) has proposed new rules for pharmaceutical companies working on biosimilar versions of interferon beta.

The new guideline outlines the non-clinical and clinical test requirements for medicines that contain interferon beta, currently approved in several branded versions as a treatment for multiple sclerosis.

These include performing non-clinical in vitro studies before initiating clinical development and following a stepwise approach once candidates move into the clinic.

The EMA's scientific advisors suggest clinical development should begin with pharmacokinetic and pharmacodynamic studies and continue with efficacy and safety studies.

Unlike traditional generic versions of small molecule drugs, biosimilar forms of biologics are similar but not identical to the originator products they are based on.

Three different first-line multiple sclerosis treatments containing recombinant interferon beta are approved in Europe: Avonex from Biogen Idec, Rebif from Biogen Idec and Betaferon from Bayer.

They have so far been immune to generic competition due to the difficulty and expense of replicating their manufacturing and development processes.

The consultation on the EMA's new product-specific biosimilar interferon beta guideline will run until the end of May.

Meanwhile the regulator is also working on revisions to general European biosimilar guidelines that will cover a range of issues including whether it is feasible to follow the legal basis for generics for some biological products.

23rd January 2012

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