Samsung Bioepis is one of several companies angling to market a follow-on version of the blockbuster immunology drug Humira, and the company recently reported preliminary data from a study showing its product could be substituted for the AbbVie medicine. Proposed federal legislation would eliminate this requirement, which bill sponsors characterize as unnecessary and expensive.
Sen. Mike Lee, a Utah Republican, initially introduced the bill last fall. The bill was recently reintroduced with a Democratic sponsor, Ben Ray Lujan from New Mexico. Two Republicans, Mike Braun from Indiana and J.D. Vance of Ohio, are also sponsors of the bill, which is called the “Biosimilar Red Tape Elimination Act.”
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When a patient goes to the pharmacy to fill a prescription for a small molecule drug, typically a pill, the pharmacist can substitute a lower-cost generic in lieu of the brand name product. That substitution does not require the pharmacist to call the patient’s physician. The follow-on equivalent of a biologic drug is known as a biosimilar. Unlike generic small molecule drugs, most states don’t allow pharmacists to substitute a biosimilar for a biologic unless the FDA has declared it to be “interchangeable.”
Interchangeability status is another step beyond FDA approval. For drugs that obtain this designation, the pharmacist can substitute the biosimilar for the brand name product without consulting with the prescribing physician. But securing interchangeability status requires a biosimilar manufacturer to conduct additional studies showing that switching to the biosimilar does not raise any safety risks or diminish the therapeutic effect compared to the reference product, which is the branded biological drug. These clinical studies take time and cost money. Lee contends they contribute to the cost of these medicines and delay them from reaching the market.
Under Lee’s bill, a biosimilar such as Samsung Bioepis’s Humira follow-on drug, Hadlima, would be considered interchangeable with its branded biological counterpart upon the drug’s approval by the FDA. The bill would amend parts of the Public Health Service Act and the Food, Drug, and Cosmetics Act. In short, the changes would eliminate the requirement that biosimilars undergo switching studies.
“Our current regulatory environment imposes onerous and costly burdens that hinder the entry of biosimilars into the market,” Lee said in a prepared statement. “Ultimately, it’s the patients who bear the brunt of limited competition and exorbitant drug prices. We owe it to them to break down these barriers and ensure they have timely access to these life-changing drugs.”
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The legislation would allow for switching studies in “special circumstances.” But the proposed changes to federal law introduce what some could consider a different layer of red tape. According to the bill, the Secretary of Health and Human Services still retains the ability to require that a drug company conduct a switching study. But first, the secretary must meet privately with the ranking member of the Senate’s Committee on Health, Education, Labor, and Pensions (HELP) as well as the ranking member of the House’s Committee on Energy and Commerce. At this meeting, the regulator would need to “explain why such a study is necessary for the biological product, what information the Secretary expects such a study to reveal, what alternatives to such study have been considered, and why those alternatives are not sufficient.’’ Lee’s staff says the bill would not affect the ability of states to craft their own biosimilar substitution laws.
Eliminating the switching study requirement would make U.S. biosimilar policy more closely resemble Europe’s. In the European Union, interchangeability used to be a hodge podge as some member states permitted interchangeability while others did not. Last year, the European Medicines Agency and the Heads of Medicines Agencies responsible for regulating medicinal products in the European Economic Area, issued a joint statement saying approved biosimilars are interchangeable with their reference product or an equivalent biosimilar. The joint position harmonized the interchangeability position across the European Union.
Anna Nayun Kim, global communications manager at Samsung Bioepis, said in an email that the company supports FDA efforts to educate healthcare professionals on “the relevance of interchangeability and how to apply it.” But the company has no position on Lee’s bill.
“It would not be appropriate for us to make predictions at this point,” Kim said.
Industry groups are publicly staying quiet on the bill. The Biosimilars Council, a division of Association for Accessible Medicines (AAM), did not respond to a message seeking comment. AAM has lobbied for various generic and biosimilar bills in the past. According to OpenSecrets, a nonprofit and nonpartisan research group that tracks money in politics, AAM spent nearly $3.2 million on lobbying last year. The Pharmaceutical Research and Manufacturers of America (PhRMA) acknowledged an inquiry from MedCity News but did not provide a response to questions about the organization’s position on the bill. PhRMA’s members include companies that make reference biological products. According to OpenSecrets, PhRMA spent $29.2 million on lobbying last year.
Lee’s bill, number S. 2305, has been referred to the Senate’s HELP committee.
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