Thursday, January 19, 2012

European Medicine Agency Issues draft guidelines for approval of biosimilar versions of Interferon beta

Medicinal products containing recombinant IFN-β 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 IFN-β are currently approved in the EU for  the first-line treatment of multiple sclerosis (MS); they differ with respect to their molecular structure, injection route, recommended posology, and MS indications.

A quick Summary of the Guidelines
As per the guidelines non-clinical studies should precede clinical studies.  The clinical studies should follow a stepwise approach starting with pharmacokinetic and pharmacodynamic studies (PK & PD) and continuing with efficacy and safety studies.Unlike trials for  innovator products in Multiple sclerosis, which have relapse rate as the primary endpoint the biosimilar trials could have MRI or disease lesions as primary endpoint, which can be supported by relapse rate as the secondary endpoint.   The clinical studies should be adequately powered and should prolong upto atleast 12 months.  The non clinical studies  should be comparative in nature and should be designed to detect differences in the pharmacotoxicological response between the similar biological medicinal product and the reference medicinal product and should not just assess the response per se.  Generally, in vivo studies in animals are not required, but If the outcome of the quality evaluation and/or the in vitro bioassays/pharmacological studies raises concerns, the need for additional studies should be considered

Approved Interforon-Beta Products in the Market include -
  1. Betaseron
  2. Avonex
  3. Rebif
The cumulative sales of Interferon beta's in the MS market is approximately $2.5b

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/01/WC500120652.pdf