In 1984, Congress passed the Hatch-Waxman Act, setting in motion more than 25 years of patent litigation between branded pharmaceutical companies and generic manufacturers and resulting in a significant expansion of generic drugs. Hatch-Waxman, however, only applied to small molecules prepared by chemical synthesis, not larger, more complex, biologic molecules isolated from natural sources. The absence of an abbreviated U.S. Food and Drug Administration (FDA) approval pathway for biologics was addressed in March 2010 when Congress passed the Biologics Price Competition and Innovation Act. Although both acts seek to simplify and expedite approval of generic drugs and follow-on biologics while simultaneously respecting patent protection for the innovator's branded products, the two acts contain very significant differences requiring careful strategic planning.
Follow-on biologics can be either biosimilar to the reference product or interchangeable with the reference product. Unlike an AB rated generic, a biosimilar follow-on biologic cannot be substituted by the pharmacist for prescriptions written for the reference product. Only an interchangeable follow-on biologic can be substituted when a prescription is written for a reference product.
Biosimilarity requires that the follow-on biologic be "highly similar" to the reference product and have no clinically meaningful differences in safety, purity, and potency from the RP. This undefined standard leaves a host of unanswered questions. What range of structural differences between the follow-on biologic and the reference product will be permitted by the FDA under the highly similar standard? What analytical testing will be required to meet that standard? What types of animal and clinical studies will be required to establish that there are no such clinically meaningful differences?
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