EU to set new biosimilar drug rules by mid-year
LONDON (Reuters) - European regulators will detail the requirements for copies of multiple types of biotech drugs by mid-2012, setting the stage for increased generic competition in a multibillion-dollar market that includes products for cancer and modern insulins. Guido Rasi, the new executive director of the European Medicines Agency (EMA), told Reuters on Friday the London-based watchdog would issue its final guideline on biosimilar monoclonal antibodies in March or April. Draft guidelines on the approval process for copies of other drugs will follow in May or June. ...
Source: news.yahoo.com
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