By Pooja Babbrah, Senior Consultant
The Food and Drug Administration (FDA) recently issued two new rules that significantly affect biologics and biosimilars.
The first rule spells out the naming conventions for biologics and biosimilars. The new guidance does several things. First, it is part of establishing regulatory and pharmacovigilance frameworks for biologics and biosimilars. This is important because it further paves the way for accelerated introduction of biosimilars in the US market. Second, it creates a unique naming convention for those drugs in the US, which departs from the way things are done in Europe following guidelines established by the World Health Organization (WHO).
Under the new final guidance, the nonproprietary name designated for each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of the core name and a distinguishing suffix that is devoid of meaning and composed of four lowercase letters. What’s more, this applies to originator biological products, related biological products, and biosimilar products that have been previously licensed and newly licensed.
Some stakeholders preferred using a meaningful suffix for the draft rule. Many believed this other approach could help make it easier to identify the manufacturer of the various products. However, the FDA stuck to its guns on the use of random four-letter suffixes. According to the FDA, this should also help to minimize “inadvertent substitution,” particularly for biosimilars that have not been determined to be interchangeable.
Stakeholders aren’t necessarily convinced. Many think this will have a huge financial impact on the industry. The National Council for Prescription Drug Programs (NCPDP) believes the FDA’s new naming conventions arise from an incomplete awareness of the comprehensive electronic programming, which underlies how drugs are prescribed and dispensed. This infrastructure–largely due to federal efforts over nearly a decade to promote health information technology–is now pervasive in the industry. NCPDP plans on making model language to that effect available to members, so they can address such concerns to the Office of Management and Budget.
A second rule focuses on interchangeability. In it, the FDA says that sponsors seeking to get a biosimilar approved as interchangeable with its reference product must conduct one or more switching studies, which would show that patients can substitute the two products safely and without diminished efficacy.
It is important to note that states are introducing legislation related to biosimilar substitution. Point-of-Care Partners is tracking these developments. Check out our regulatory resource center, which makes it easy for you to keep up with state and federal regulatory actions related to biosimilars. For additional information, an overview of biosimilar legislation and an explanation of the value proposition for your situation, contact Connie Sinclair, who heads the Center. She may be reached at 404-915-2881 or at email@example.com.