Follow-on biologics: data exclusivity and the balance between innovation and competition

Abstract

| Legislation to create a regulatory pathway for follow-on biologics is currently being considered by the United States Congress. A critical issue in this respect is the period of data exclusivity for innovator companies before a follow-on competitor can rely in part on data obtained for an original biologic for an abbreviated approval. Given the nature of patents on biologics, the period of data exclusivity is anticipated to have a key role in determining how quickly follow-on competitors emerge, and consequently also on the time available for originator companies to recoup their investment. With this issue in mind, this article discusses factors influencing return on investment on biologic research and development. A break-even analysis for a representative portfolio of biologics provides support for a substantial data exclusivity period. NATURE REvIEWS | drug discoveryADvANCE ONlINE PUBlICATION |

Intellectual Property, Information Technology, Biomedical Research, and Marketing of Patented Products

“…The European Union provides 10 years of data exclusivity for new molecular entities. It also adds an extra year for drugs that get a "significant new indication" approved within their first eight years on the market (Grabowski, 2008).…”

“…While this serves to strengthen market exclusivity, it is distinct from a patent, which grants IP over the chemical structure of a drug, rather than data about the drug. Since data exclusivity is immune to legal challenges, it establishes a "floor" on patent length (Grabowski, 2008).…”

Recent Advances in Biotherapeutics Drug Discovery and Development

“…Clinical testing in human for new biotherapeutics drugs entails a large sum of financial investment. Though biotherapeutics have higher probabilities of clinical success, they have a higher attrition rate in phase III trials than small-molecule drugs (Grabowski 2008), indicating that the failure results are known only after high development cost have been incurred. Improving trial designs with biomarker identification and proper patient selection is the key to decreasing trial attrition rate.…”

Biotechnology: Delivering on the Promise

“…Th e language under consideration by Congress would follow this model and maintain parity with small-molecule makers by allowing the original developer of a biologic to protect the proprietary data used to develop the medicine for at least 12 years. A shorter exclusivity period would prematurely deprive biotech innovators of their intellectual property and biotech investors of adequate time to gain a return on their investments (12). Establishing an effective and fair regulatory pathway for biosimilars that will lower costs and increase the number of patients who have access to pharmaceuticals will give investors confi dence in backing biomedical innovation.…”