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Mexico Aims to Become a Global Leader in the Regulation of Biologic and Biosimilar Medicines, According to New Market Research

(June 13, 2012)

ROCKVILLE, MD -- (Marketwire) -- 06/13/12 -- has announced the addition of the new report "The Pharmaceutical Market: Mexico," to their collection of Pharmaceuticals market reports. For more information, visit

The pharmaceutical market in Mexico remains the second most attractive in Latin America. The Economist Intelligence Unit (EIU) projects a weak exchange rate for the Mexican peso in the forecast period, which will affect the value of the Mexican pharmaceutical market in US dollar terms. The CAGR will be moderate between 2011 and 2016. Some factors that will contain the market include: tighter out-of-pocket pharmaceutical expenditure due to tough economic conditions; a number of key pharmaceutical and biologic drugs losing their patents in the next few years; intensifying competition from foreign (generic) producers, which no longer need to manufacture locally; an infant bioequivalent generic sector that is expected to shoot up in the forecast period; and price negotiations in the increasingly large public sector.

Generic sales in Mexico are still negligible in the private pharmacy sector. However, the National Association of Interchangeable Generic Medicines (AMEGI) believes that consumption of generic medicines in the private pharmacy sector will increase considerably in the forecast period. A number of patents for bestselling drugs will expire in the coming years, and this will accelerate generic market growth. Generic sales are high, when considering sales in the public sector. The public sector is accountable for about 80.0% of generic sales by value, whilst the private pharmacy sector represents the remaining 20.0%; generic sales represent 3.5% of pharmacy sales. In terms of competition, a number of foreign producers, i.e. Sanofi and Valeant, have acquired a couple of local producers, whilst others have formed partnerships with local producers.

Mexico aims to become a global leader in the regulation of biologic and biosimilar medicines. A decree that reformed and updated the Regulation of Health Supplies (RIS) in terms of biologic medicines was signed and published in the official bulletin (DOF) in October 2011. The new decree provides the legal requirements for any company interested in registering a biologic or "biocomparable" drug in Mexico; Mexico has opted for using the "biocomparable" term rather than the most commonly used "biosimilar" term to define off-patent biologics "comparable" with innovative biologics. The new decree will be enforced 180 days after its publication in the DOF; any registration requests for biologic medicines remaining on the enforcement date will be resolved considering the requirements valid when the original submission took place.

For more information, visit

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