By Todd Ebert
A revolutionary new class of drug has the potential to increase patient access to life-saving treatments and to reduce costs for the entire healthcare system. Earlier this year, the U.S. Food and Drug Administration (FDA) began approving biosimilar drugs, medications that are copies of and have no clinically meaningful differences from reference biologic products. If patients and the healthcare delivery system are to realize the full public health and cost-savings potential of biologics, however, the FDA needs to issue clear and timely guidance to the market and create a pathway to market that prioritizes patient safety and encourages development and uptake of these less-costly therapies.
Biologic drugs have revolutionized treatment for many living with serious chronic or life-threatening conditions. However, because they are made from living matter and are structurally complex, they are more difficult to develop and manufacture and often come with a price tag that puts the medications beyond reach for many patients.
The advent of biosimilars will increase competition in the pharmaceutical marketplace and drive system-wide cost-savings. One recent study from Express Scripts projected savings of $250 billion over 10 years should only the 11 likeliest biosimilars enter the market. In the European Union, where biosimilars have been safely available for years, the drugs cost, on average, 30 percent less than their reference biologics.
The Healthcare Supply Chain Association (HSCA) believes that reference biologics and their biosimilars should share the same International Nonproprietary Name (INN). The FDA has proposed unique suffixes for biosimilars; however, HSCA is concerned that suffixes for biosimilars might lead to clinician confusion and hinder adoption of biosimilars by creating the mistaken impression that a biosimilar product will behave differently than its originator.
In addition to limiting the cost-savings potential of biosimilars, suffixes will also create an additional financial burden to the system, as existing software across the healthcare supply chain will require changes to account for the addition of new suffixes to INNs. In comments filed with the FDA earlier this year, HSCA encouraged FDA to move quickly to finalize its naming guidance so that appropriate education of supply chain stakeholders can take place.
The ability to safely substitute FDA-approved biosimilars for reference biologics will be critical to realizing the full cost-savings and access potential of biosimilars. It is important for the FDA to issue clear and robust guidance on the requirements for a biosimilar product to obtain an “interchangeable” designation. FDA’s guidance on interchangeability will have an impact on state level substitution and, ultimately, provider and patient access to biosimilars.
HSCA and its members are committed to lowering costs and increasing competition and innovation in the healthcare marketplace. We are working with the FDA to help ensure a pathway to market for biosimilars that prioritizes patient safety and encourages development and uptake of these less-costly therapies. We urge the FDA to continue the progress it has already made by issuing the timely guidance necessary to create safe and expedient patient access to biosimilars.
Todd Ebert, R.Ph., is the president and CEO of the Healthcare Supply Chain Association.