20/01/2012
EU agency issues guideline on biosimilar MS drugs
European regulators took another step towards opening the market for copies of biotech drugs 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 London-based agency.
Guido Rasi, the organization's new executive director, told Reuters on January 6 the watchdog 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, which are given by injection, have been largely immune from generic competition, unlike conventional chemical pills and capsules.
But the regulatory landscape is starting to change, 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.
By Ben Hirschler
REUTERS
http://www.reuters.com/
http://www.reuters.com/article/2012/01/20/us-biosimilars-interferon-idUSTRE80J0O020120120?feedType=RSS&feedName=healthNews&utm_source=dlvr.it&utm_medium=twitter&dlvrit=309303
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