Mexico - How are biologics & biosimilars regulated in Mexico?

In September 2009, the regulatory reform for the sale and production of biologic and biosimilar medicines was enforced.

The new regulation establishes the requirements to launch ‘biocomparables’, which is the term chosen in Mexico to define off-patent biologics ‘comparable’ with innovative biologics; other terms such as ‘biosimilars’, ‘biogenerics’ or ‘non original biologics’ are rejected. The new regulation also sets out the creation of a Committee of New Molecules and a Subcommittee of Biologic Medicines to determine, on a case-by-case basis, the clinical or in vitro studies necessary for market registration, depending on the medical use of the product. Once marketed, a pharmacovigilance system will assess these products.

The new regulation represents sizeable opportunities for both local and foreign producers. Local producers such as Probiomed, Silanes and Landsteiner Scientific already produce biologic medicines in Mexico. Competition, however, is expected to arise from foreign producers such as Roche, Amgen, GlaxoSmithKline, Sandoz, Teva and Ranbaxy. On a patient level, the new regulation provides more safety and availability, as the sector had grown in the country without any legal framework.

Further reading - A detailed analysis of the Mexican pharmaceutical market is available from Espicom: The Pharmaceutical Market: Mexico (published January 2010)