No Longer "If," But "When": The Coming Abbreviated Approval Pathway for Follow-on Biologics

Date: February 20, 2009


Abbreviated approval of follow-on biologics involves answering complex scientific, legal, and policy questions. The Food and Drug Administration (FDA or the Agency) asserts that it lacks the statutory authority to approve follow-on versions of biologics licensed under §351 of the Public Health Service Act (PHSA). Despite persuasive arguments to the contrary, the 110th Congress entertained four legislative proposals to give FDA this authority, each markedly different. It is no longer a question of "if," but rather "when" FDA will receive authority to review and license abbreviated applications for follow-on biologics.

Any legislation in the 111th Congress must determine: (i) if FDA should be granted authority to develop an abbreviated pathway through rulemaking or guidance; (ii) if human clinical trials should be mandatory or discretionary; (iii) the feasibility of interchangeability determinations in light of patient safety concerns; (iv) the duration of marketing exclusivity for associated products; (v) which products are eligible for follow-on approval; and (vi) the degree to which uniformity is achievable between the FD&C Act and the PHSA. This paper recommends the 111th Congress strike a balance between patient safety, incentives for product innovation, price competition, and the need for a flexible, transparent regulatory process that capitalizes on FDA's growing expertise with follow-on biologics approvals under §505(b)(2) of the FD&C Act.

Open the attached PDF to read the full article.

Published in the Food & Drug Law Journal (64 Food & Drug L. J., 115-148 (2009)) and posted with permission of FDLI.