Biosimilar Drug Makers Push Back on Proposed Exclusivity Revision

Samantha DiGrande

The Trump administration this week announced a preliminary trade deal between the United States and Mexico. Under the agreement, which looks to update the North American Free Trade Agreement, brand name drug makers will receive 10 years of exclusivity for biologics in addition to more products qualifying for this protection.

The Trump administration this week announced a preliminary trade deal between the United States and Mexico. Under the agreement, which looks to update the North American Free Trade Agreement, brand name drug makers will receive 10 years of exclusivity for biologics in addition to more products qualifying for this protection.

Conversely, generic drug makers strongly oppose the deal as it lengthens the current period of exclusivity in Mexico—at the moment, Mexico’s period of exclusivity for biologics is just 5 years.

“This provision would harm the growing biosimilar industry, which aims to provide price competition to some of the most expensive prescription drugs and allow patients to benefit from affordable medicines,” according to a statement from the Association for Accessible Medicines. “The [United States], Mexico, and Canada should reject these provisions, which would benefit brand-name drug companies to the detriment of public health and the affordability of medical care.”

However, brand-name drug manufacturers actually pushed for the policy to include 12 years of protection, as it currently stands in the United States.

“We encourage the administration to continue pushing for strong trade deals that protect and value the life-saving medicines our companies develop and deliver to patients,” said trade industry group PhRMA in a statement. “We look forward to finalizing the text of the agreement once completed to ensure it includes policies that protect against global free-riding, promote research and development, and reward the innovation being pioneered by America’s biopharmaceutical companies for patients across the globe.”

Though the new agreement is not final, the president of Mexico, Enrique Peña-Nieto has emphasized the importance of Canada joining the deal as well. Canadian Foreign Minister Chrystia Freeland arrived in Washington, DC late this past Tuesday, and it thus far remains unclear whether a trilateral agreement will be reached.

The White House will have to send a formal trade agreement to Congress within 30 days, at which point Congress would have an additional 60 days to review the completed deal before the Mexican government potentially approves it in late November, before its new president takes office on December 1.