Under the draft guidance for industry, the FDA is proposing how manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same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with a notice of proposed rulemaking to allow states to submit proposals for importing medicine from Canada, as well as draft guidance for industry that would allow manufacturers to sell versions of drugs that they develop for overseas in the United States as well, but it appears that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Under the draft guidance for industry, the FDA is proposing how manufacturers could import versions of FDA-approved drug products that they sell in foreign countries that are the same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.
Budget Impact Analysis of Biosimilar Natalizumab in the US
Projected savings from biosimilar natalizumab were $452,611 over 3 years, driven by decreased drug acquisition costs and a utilization shift from reference to biosimilar natalizumab.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Hesitancy in MENA Nations to Adopt WHO Biosimilar Guidelines Hinders Market Development
July 17th 2024The World Health Organization’s (WHO) new guidelines for biosimilar approvals aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.
BioRationality: Time to Get Rid of PBMs if Biosimilars Are to Succeed
July 15th 2024Sarfaraz K. Niazi, PhD, discusses the challenges with pharmacy benefit managers (PBMs) that plague the biosimilar industry and new legislation that attempts to reform their practices and encourage biosimilar adoption.