EMA draft guideline for biosimilars containing interferon beta

European Medicines Agency (EMA) took another step towards opening the market for biosimilar today by releasing a draft guideline on how companies should test biosimilar medicines containing interferon beta, used to treat multiple sclerosis.

The guideline is open for consultation until the end of May 2012 and is part of a package of new regulations being prepared by the EMA.

Guido Rasi, the organization’s new executive director, told Reuters on January 6 the agency would issue its final guideline on biosimilar monoclonal antibodies — the biggest category of biotech medicines — in March or April.

Leading multiple sclerosis (MS) drugs containing interferon beta include Merck KGaA’s Rebif and Biogen Idec’s Avonex.

Up to now, complex biotechnology medicines, have been largely immune from generic competition, unlike conventional chemical pills and capsules.

But the regulatory landscape is starting to change (Editor’s note: has already started for sure), posing a threat to leading biotech groups like Roche and Amgen, as well as makers of MS drugs and suppliers of insulin, such as Novo Nordisk.

Source: Reuters and EMA, 19 January 2012