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Biotechnology: The Waiting game

11.04.2013 / Pharmaboardroom

As in many emerging countries, it is taking a while for Mexican legislation to catch up with the latest technologies. Alejandra Mendoza, general manager of Genzyme Mexico, says that regulation has been the main challenge her firm has had to face. “We were pioneers in biotech in Mexico, so we had to approach the health authorities with therapeutic solutions that did not fit in Mexico’s regulatory framework! It took us three years, from 2002 to 2005, to be allowed to bring drugs into Mexico under the category of orphan drug, a category which did not previously exist here.”

Since then, Mendoza explains, there has not been one year in which the company has not introduced a new product into the Mexican market. “What really keeps us busy is keeping up with the launching of our new products,” she says proudly. For Mendoza, despite the many challenges, launching operations in Mexico was the right decision. “Genzyme is here to stay, and to continue bringing the best therapies. We have a long term commitment to the country and to our Mexican patients.”

The Mexican government is making efforts to adapt the regulatory framework to biotech products. In this sense, the country’s Congress is currently discussing legislation on biosimilars. This draft legislation can be seen as a step in the right direction, but some are skeptical about how long it will take the authorities to act on it; for the last few months the legislative agenda has been monopolized by a controversial energy reform.

According to Esther Lucero Zarate Villa, regulatory affairs & safety director for Amgen in Latin America, a key challenge biotech firms find in emerging markets such as Mexico is the fact that, unlike developed markets, these countries have no reimbursement schemes. Thus, in Mexico, only a very small part of the population can afford expensive biologics. “We will sell to the private market, but we will not succeed in these markets if we are not able to work closely with the government,” she argues.

Amgen has analyzed the potential of Asia Pacific, the Middle East, and Latin America, evaluating these regions from different points of view such as regulation and pricing, with an eye toward creating a tailor-made business plan for each market. “In Latin America, at present we are focusing in the biggest countries, Brazil and Mexico, because together they make up 80 percent of sales in this region,” says Zarate Villa. “These are countries with good regulatory frameworks, well-defined markets, and governments that aim to promote companies with high levels of research in the country. Amgen conducts R&D activities in those countries. We have around 3,500 patients participating in clinical trials in Latin America.”

Amgen has huge expectations for Latin America. “We have great hopes because Amgen has excellent products, a uniquely robust pipeline and is very well structured and organized. Now the challenge is to extend this corporate structure to these markets,” Zarate Villa explains.

Thanks to their size and fast economic development rates, large, emerging markets are more and more attractive for biotechnology firms. Nevertheless, these companies will have to be highly innovative in their strategies to engage patients, doctors, and governments; as their main strength, their strong pipelines, will not be enough on its own to guarantee them success.

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