Biosimilar Stakeholders Praise Removal of Biologic Exclusivity Provisions From USMCA

An agreement on the United States—Mexico–Canada Agreement (USMCA), a trade deal that updates the North American Free Trade Agreement, has been reached, and proponents of biosimilars and generics have cause to celebrate after the removal of provisions that some said would hinder competition.

The full text of the newly agreed version of the deal is yet to be publicly released. However, the chairman of the House Committee on Ways and Means, Richard Neal, D-Massachusetts, said in a statement outlining features of the final agreement that House Democrats were successful in their attempts to remove provisions of the deal that would have required all parties to provide at least 10 years of exclusivity for biologic drugs, to remove provisions that would have allowed patent evergreening on drugs, and to cut provisions that would allow 3 extra years of exclusivity for clinical information submitted in connection with new uses of existing products.

The revised agreement also includes clarification on circumstances in which generic and biosimilar developers can use patented inventions in order to gain marketing approval on the first day after patent expiry.

Biosimilars and generics trade group the Association for Accessible Medicines called the revised deal a victory for patients, saying that the new agreement creates greater opportunities for patients in all 3 nations to access less expensive prescription drugs.

The Canadian Generic Pharmaceutical Association also praised the deal; president Jim Keon said that the removal of the 10-year exclusivity provision is particularly important for Canadian patients, noting that the provision could have delayed the availability of biosimilar medicines in Canada, where biosimilars are increasingly seen as a crucial part of national attempts to reduce prescription drug costs.

In the United States, AARP’s executive vice president and chief advocacy and engagement officer, Nancy LeaMond, said in a statement that “there is no reason why the [United States] should continue to pay the highest drug prices in the world. Americans, along with our Canadian and Mexican neighbors, scored a noteworthy victory today against ‘big pharma’ that pushed hard to keep these provisions in the USMCA.”

Perhaps unsurprisingly, the Pharmaceutical Research and Manufacturers of America, or PhRMA, which represents innovator drug makers, took a dim view of the revisions; president and chief executive officer Stephen J. Ubl said that removal of biologics exclusivity provisions would do “nothing” to help patients, and that the revised deal will help foreign governments “who want to steal American intellectual property and free ride on America’s global leadership."

Similarly, the Biotechnology Innovation Organization, which represents biotech companies, said that the United States had given up an important tool to “end foreign free-riding on American medical innovation.”