BPCIA: Beyond the Hatch-Waxman Act

Small Molecules versus Large Molecules

Historically, small molecules and large molecules have been governed by substantially different laws and regulations. The differences in treatment arose primarily from the difference in the complexity of the products. The manufacturing process for these products also reflects the differences in complexity. Small molecules can be made through laboratory synthesis, whereas large molecules are manufactured in living systems.


The Hatch-Waxman Act established an abbreviated pathway for the approval of generic drugs in 1984; however, a pathway to facilitate the approval of biosimilars was not enacted until 2010.

Congress created the Biologics Price Competition and Innovation Act (BPCIA) to abbreviate the approval pathway for biosimilars, similar to abbreviated approvals for small molecules established in the Hatch-Waxman Act (HWA). Although the provisions of BPCIA incorporate some of the Hatch-Waxman concepts, the provisions are not the same.

The differences in legal and regulatory structure arise because biosimilar manufacturers cannot make an identical copy of the innovator biologics. These differences have a substantial impact on biosimilar approval requirements, patent and regulatory exclusivity provisions, and market dynamics.

Although the FDA has provided guidance to address some aspects of biosimilar approvals, it has adopted a “totality of evidence” approach to provide flexibility in the requirements for specific biosimilar applications. Accordingly, the clinical testing needed to demonstrate that a biosimilar is “highly similar” to the innovator will be determined case-by-case.

The differences in biosimilar approval requirements, patent and regulatory exclusivity issues, and market dynamics require innovator companies to adopt different strategies to manage the lifecycles of innovator biologics. Despite the uncertainties that remain, the biologics market for innovators and biosimilars will remain a significant source of growth for the pharmaceutical industry for the foreseeable future.

The continued pursuit of innovative biologics and the development of the biosimilar market will produce a robust competitive market for large molecule drugs that is similar, but not the same as, the robust market between brand-name and generic small molecule medicines.

Leading Authority

Gregory Glover is one of the nation’s leading experts on the complex interaction between FDA regulations and intellectual property. He works with pharmaceutical and biotechnology companies and investors on strategic issues related to product life cycles.

Greg has testified on behalf of the research-based pharmaceutical industry before both houses of Congress, the FDA, the Federal Trade Commission, and the Department of Justice. Greg’s expertise includes the patent and non-patent market exclusivity provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), and analogous provisions of the Biologics Price Competition and Innovation Act (BPCIA).

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