“States may be more restrictive regarding automatic substitution of biologic drugs owing to their greater structural complexity than small-molecule drugs, and thus to concerns over the ‘sameness’ of biosimilars to biologics,” Dr. Sarpatwari says.
If the biosimilar can be shown to be completely clinically identical to the original biologic drug, the U.S. Food and Drug Administration (FDA) can classify it as “interchangeable,” as opposed to similar to the brand-name product, notes Francis Crosson, MD, a senior instructor at the Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., who wrote a commentary accompanying the study.2
However, the FDA has not yet classified any generic biologics as interchangeable, Dr. Crosson says by email.
“So, in many states, regulators can’t really maintain that biosimilars are exactly the same as the original biologic, like they can with generics,” Dr. Crosson says. “So, they have been more conservative in their approach. If and when interchangeable biosimilars are classified as such by the FDA, some states may see the situation differently.”
References
- Sacks CA, Van de Wiele VL, Fulchino LA, et al. Assessment of variation in state regulation of generic drug and interchangeable biologic substitutions. JAMA Intern Med. 2020 Aug 31. Online ahead of print.
- Crosson FJ. Addressing the cost of biologic and specialty drugs. JAMA Intern Med. 2020 Aug 31. Online ahead of print.
