Mexico’s biotechnology industry made an international splash this year when a biopharmaceutical treatment for scorpion stings developed in Mexico was approved for sale in the United States by the U.S. Food and Drug Administration (FDA). The product, called Anascorp, was developed by the Biotechnology Institute of the National Autonomous University of Mexico (UNAM) and is manufactured by Mexico City-based laboratory Instituto Bioclon. It is reportedly the first antidote of its type specifically for potentially lethal scorpion stings to be available on the U.S. market.
While Anascorp captured headlines, Mexico has quietly been building up its biotechnology industry in recent years. Sporadic projects to develop hardier agricultural varieties began in the late 1980s, and since have grown into a concerted effort by government and academia to promote biotechnological research and development in support of industry. Much attention has been given to the field as part of recent administrations’ drive to build Mexico’s international competitiveness in advanced industries such as aerospace, software and pharmaceutical manufacturing. The majority of resources currently dedicated to biotechnological research in Mexico are reported to be concentrated in the development of pharmaceuticals, with agriculture and energy applications also receiving significant attention. The Mexican Economy Ministry estimates the domestic market for products of biotechnological origin to be approximately US$1 billion with strong growth potential.
Federal and state governments are now seeking to replicate the success of the country’s aerospace industry by promoting incentivized biotechnology clusters in certain locations. The government of the central state of Morelos, for example, is investing US$25 million in a new science and technology park in the city of Cuernavaca specifically targeting producers of biopharmaceuticals. The government is offering tax breaks and other incentives plus the existence of other biotech companies in the city to build an industry concentration that will gather momentum to continue expanding on its own.
The western state of Jalisco is taking a slightly different approach with its recently formed Biocluster de Occidente. The initiative, launched through an alliance between a local university, a regional manufacturing chamber and a state research and technology agency, will provide resources and logistical support to organize workshops, conferences and networking events to develop linkages between academia, government and industry. The objective is to generate collaboration across the sectors to support industrial competitiveness and entrepreneurship that will create economic growth. The project will reportedly begin working with 37 area companies in industries such as food science and human and animal health technologies.
The northeastern state of Monterrey, in turn, is pursuing its own biotechnology cluster focused primarily on the agriculture and food processing industries. The state’s Cluster Agroalimentario de Nuevo León launched last year to put government and research organizations’ resources in the service of area agribusiness operations such as those in the citrus industry. The cluster committee is currently conducting a campaign to recruit new companies from around the world to join the existing core group.
Despite an adverse economy, Mexico’s biotechnology community continues to grow. Mexican pharmaceutical manufacturer Landsteiner Scientific recently announced planned investment of US$45 million in research to develop biopharmaceuticals for treatment of cancer and chronic degenerative diseases in conjunction with the Monterrey Technical Institute and the University of Michoacán. Another Mexican firm, Biosustenta, this year inaugurated a plant to produce environmentally friendly biofertilizers. The facility, built with federal and state support, is reportedly the largest of its kind in Latin America. This past October, German pharmaceutical producer Boehringer Ingelheim joined Jalisco’s biotechnology community, inaugurating a plant develop and manufacture vaccines for poultry and other livestock.
The rise in importance of biotechnology has brought with it an effort to update regulatory frameworks to keep pace with an evolving industry. On October 19, 2011, Mexico’s Official Gazette (DOF) published modifications to existing regulations governing health products that specifically addressed biopharmaceuticals. The updated legislation includes key provisions on registration of generic biopharmaceuticals once the original developer’s patent expires. The new regulations establish the process for registration of generics and time frame within which manufacturers may register their products for testing prior to the expiration of an existing drug’s patent.
For the full text of the reforms to the Health Products Law, go here.
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