Myths vs. Facts of Biologic Market Exclusivity in Mexico — #FixUSMCA

The pharmaceutical provisions included in the negotiated text of the U.S.-Mexico-Canada Agreement will do many things. But creating a market for biologics in Mexico is not one of them. Why? Because pharmaceutical companies have been selling original biologics in Mexico since before 2001.
USMCA Nothing to See Here Infographic

Mexico, based on drug regulator COFEPRIS’s policy, provides five-years of data exclusivity for new chemical entities. While biologics are not explicitly included in the COFEPRIS regulations, they have, for practical purposes, extended that protection to biologics as well:

“(I)n 2012, COFEPRIS issued an official communication dictating the guidelines for Data Exclusivity, which stated that this type of protection would exclusively apply to new chemical entities; biotechnological drugs were not explicitly mentioned, but what happened ever since, is that Data Exclusivity has been provided for both, new chemical entities and biotech drugs all the same. No further distinctions between these two classes of pharmaceuticals have been attempted.”

In fact, of the top 12 selling biologics in the United States, all of them are available in Mexico. For example:

  • The best-selling drug in the world, Humira ($19.9 billion in global sales in 2018), was registered by the Mexican regulatory authority in 2003 and still does not face biosimilar competition in Mexico (but it does in Europe).
  • Avastin ($6.85 billion in global sales in 2018) was registered in 2005 and does not face biosimilar competition in Mexico; a biosimilar was approved in Europe in 2018.
  • Lucentis ($1.67 in global sales in 2018) received approval in Mexico in 2007 and does not face biosimilar competition in the market.

Provisions that extend biologic exclusivity past five years are not needed in the USMCA to establish a robust biologic market. That market already exists.

Download a PDF of more myths vs. facts: Pharmaceutical Provisions in the USMCA Myths vs. Facts 

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Jonathan Kimball

By Jonathan Kimball, AAM Vice President, Trade and International Affairs




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