Approval of follow-on biologics in Mexico

por Armando Arenas y Juan Luis Serrano The Mexican General Health Law was reformed on 11th June 2009 to include Article 222bis, which defined biotechnological drugs and allowed for the approval of so-called “biocomparables”. The decree came into force on 8th September 2009 and the Ministry of Health had a 180-day period to issue all the specific regulations pertaining[...]
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