Biopartners withdraws marketing authorisation application for Biferonex

Biopartners has withdrawn its application to the European Medicines Agency for a centralised marketing authorisation for Biferonex (interferon beta 1a) 6MIU solution for injection in prefilled syringes. The drug is developed to treat adults with relapsing-remitting multiple sclerosis.

The Swiss biopharmaceuticals firm submitted its application in July 2007. On 19 February 2009, the EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the non-granting of the marketing authorisation. Following this, the company requested a re-examination of the opinion, which was under review by the CHMP at the time of the withdrawal. This decision was taken because the CHMP considered the benefit not to be sufficiently established by the submitted data.

Biopartners said the body of evidence is strong in support of the product's safety and efficacy and that a positive risk/benefit profile is adequately established. The company says it is comparable with the profile of other interferon beta products approved in the EU for treatment of relapsing-remitting multiple sclerosis.

Biopartners reserves the right to make further submissions at a future date in this or other therapeutic indications.