US eyes faster launch for biosimilars in North American trade pact; reports

Biosimilars could be brought to market much quicker in North America if a Trump administration proposal makes it into a new US-Canada-Mexico (USMCA) trade pact, according to press reports.

Citing people familiar with the matter, the Wall Street Journal says the US government is considering a reduction in the protections from competition for biologic drugs detailed in the USMCA from 10 years to five, to try to win support for the deal from Democrats in Congress.

Biologics have 12 years’ market exclusivity in the US, but the current wording of the trade agreement would reduce that to 10.

For comparison, Canada currently has eights years’ protection and Mexico five, so under the current wording patients would have to wait longer for biosimilars in the latter two countries.

Democrats and other groups have argued for the duration of the additional protection to be reduced to to allow cheaper copies of reference biologic drugs to get to market more quickly, as that would help cut spending on medicines by healthcare systems in all three countries.

Some have also argued for the provision to be dropped altogether, with the three countries retaining the status quo on biologics protection.

Companies that produce biosimilars in the US are also pushing for the reduction of course. The Association of Accessible Medicines – which represents generic and biosimilar manufacturers – argues that passing the USMCA with a five-year provision would prevent a biopharma monopoly from being expanded beyond the US and lower prescription drug prices for America's patients.

Trump is keen to get the USMCA passed, as he has pledged a series of trade deals to boost the US economy in the build-up to the Presidential election next year. USMCA was agreed in principle by the US, Canada and Mexico a year ago, but still needs to be ratified by Congress.

The governments of Mexico and Canada would clearly need to agree any changes to the biologics’ exclusivity provisions in the trade deal if they do make it into the document.

Trump signed the USMCA in November 2018, shortly before the Democrats took control of the House of Representatives in the midterms. The shift in power has held up the treaty, which is the successor the North American Free Trade Agreement (NAFTA).

Last week, top Democrat Nancy Pelosi said that discussions with US Trade Representative (USTR) Robert Lighthizer were getting closer to an accord that could allow the USMCA to be tabled for a vote, with a few ‘wrinkles’ – such as enforcement of the provisions – still to be worked out.