Do Biosimilars Have a Role in US Plan to Allow Imports?

Under the draft guidance for industry, the FDA is proposing how manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the US versions. Under this pathway, drug makers would use a new National Drug Code (NDC) and sell the products in the United States at a cheaper price—but different NDCs will not be available for use by biosimilar manufacturers.

The United States is proceeding with a notice of proposed rulemaking to allow states to submit proposals for importing medicine from Canada, as well as draft guidance for industry that would allow manufacturers to sell versions of drugs that they develop for overseas in the United States as well, but it appears that biosimilars would not have a route through either pathway.

The importation proposal was first raised in July.

Through the first pathway, states would send proposals to the FDA to allow the importation of small-molecule, brand-name medicines sold at retail pharmacies— typically ones that have rebates attached to them, according to HHS Secretary Alex Azar.

Some states—Florida, Vermont, and Colorado—have enacted legislation that allows them to import drugs, but they need HHS’ approval to proceed.

The proposed rulemaking targets Section 804 under the Federal Food, Drug, and Cosmetic Act (FFDCA), which regulates US prescription drugs. Section 804 already gives the HHS secretary the authority to create regulations to allow pharmacists and wholesalers to import unapproved prescription drugs from Canada, as long as the secretary certifies that the program would create no additional risk to health and safety and would lower costs.

“This is a historic first step,” said Azar.

Under the draft guidance for industry, the FDA is proposing how manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same as the US versions. Under this pathway, drug makers would use a new National Drug Code (NDC) and sell the products in the United States at a cheaper price.

However, different NDCs will not be available for use by biosimilar manufacturers, he said.

Taken together, the plans aim to increase access, lower drug costs, and stimulate competition, administration officials said. However, Azar could not quantify how much could be saved, either by states or consumers.

Under the pilot plan for states, intravenous or infused drugs, biologics, or drugs with risk evaluation and mitigation strategies are not eligible for importation.

In order to meet the FDA’s criteria, drugs considered for importation must have been approved by Health Canada and would need to meet requirements for a New Drug Application (NDA) or an abbreviated NDA; the products would be relabeled for US use and sold through approved wholesalers and pharmacies.

“I want to repeat: we will not take steps that would put patients or our drug supply at risk,” said Azar.

Proponents of drug importation have noted that FDA-approved drugs are already made in foreign facilities that the FDA inspects and approves. “Provided the drugs consist of the same [active pharmaceutical ingredient] APIs in the same strengths, and they are administered by the same route…it is irrelevant with respect to health and safety risks whether the drugs were originally intended by the manufactured for sale in Europe or Canada or Asia or USA,” according to a report created for the Vermont state legislature earlier this year.

The continuing furor over drug costs often features widely used therapies, older therapies such as insulin, as well as costly biologics for autoimmune diseases.

Survey after survey has shown that American consumers are skipping doses or not filling prescriptions altogether due to rising drug costs.

The plan is opposed by the pharmaceutical industry lobbies on both sides of the US-Canadian border.