JAMA : the journal of the American Medical Association
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Biologics approved by the US Food and Drug Administration (FDA) receive 12 years of guaranteed protection from biosimilar competition compared with 5 years of protection from generic competition for new small-molecule drugs. Under the 2022 Inflation Reduction Act, biologics are exempt from selection for Medicare price negotiation for 11 years compared with 7 years for small-molecule drugs. Congress codified these differing legal protections on the premise that biologics require more time and resources to develop and have weaker patent protection, necessitating additional protections for manufacturers to recoup their development costs and generate adequate returns on investment. ⋯ There is little evidence to support biologics having longer periods of market exclusivity or protection from negotiation. As a result of differential treatment, US law appears to overly reward the development of biologics relative to small-molecule drugs.