The Regulation of Follow-on Biologics

John Manthei is a partner at Latham & Watkins and serves as global Co-chair and Washington, D.C. Chair of the firm's Health Care and Life Sciences Practice. His practice focuses on regulatory matters involving the US Food and Drug Administration (FDA) for the medical device, pharmaceutical, biotechnology, food and dietary supplement industries.

What is new in the world of follow-on biologics?

Manthei: Congress enacted the Biologics Price Competition and Innovation Act of 2009 to provide an alternative to the submission of a Biologics License Application for certain biologic drugs that are interchangeable with or similar to previously licensed biologic products. The Act expanded the FDA's authority to regulate follow-on biological products pursuant to this new regulatory scheme. 

What changes have there been in the regulation of these products?

Manthei: FDA’s implementation of the regulatory scheme for follow-on biologics continues to take shape. In the past year, FDA has taken steps to interpret and implement these new provision. The past year has also seen developments in the responses of state governments and other stakeholders. The implementation of this new legislation is important for both innovators of licensed biologics drugs and sponsors of follow-on biologics. Biologics companies should understand and consider the impact of the evolving follow-on biologics program on their respective businesses.

What does the Biologics Price Competition and Innovation Act entail?

Manthei: The Biologics Price Competition and Innovation Act establishes two product categories for follow-on biologics – biosimilars and interchangeable biologics.  It includes provisions regarding data requirements, the product development and licensure process, patents and exclusivity, among other things. In addition, the Biosimilars User Fee Act of 2012 establishes user fees associated with the development and approval of follow-on biologics, including various development fees that apply early in the regulatory process. At the same time, the legislation leaves open a number of major issues that FDA must address. These include issues relating to product nomenclature, standards for interchangeability, and the burdens of the data requirements under the new regulatory scheme. 

As a result, these and other important issues must be resolved by FDA’s implementation of the Act.  In addition to the federal legislation, there have also been recent state legislative efforts dealing with the substitution of follow-on biologics for brand-name products by pharmacies, as well as developments in the European Union which may ultimately impact US regulation.   

What are the three main takeaways that I should know about this new regulatory scheme?

1. Although the provisions of the Act may provide new incentives for the development of follow-on biologics, FDA’s implementation of the follow-on biologic program remains ongoing and full implementation is likely to take several years. As of June 2013, it does not appear that FDA has received a single application for a follow-on biologic product although it has held preliminary meetings with several companies.

2. FDA has issued numerous draft guidances and provided various opportunities for public and industry input as it implements the new regulatory scheme. Interested parties should be sure to stay abreast of FDA’s activities and take advantage of opportunities to provide input on issues important to their business. 

3. The licensure pathway created by the Biologics Price Competition and Innovation Act differs from the follow-on biologic legislation in place in the EU, which approved its first follow-on biologic in 2006.  In particular, the Act allows FDA to license follow-on biologics as either biosimilar or interchangeable, and offers the benefits of exclusivity to certain interchangeable biologics.