Two bipartisan bills, the Advancing Education on Biosimilars Act and the Ensuring Innovation Act, were signed into law by President Biden on April 23, 2021.  According to U.S. Senator Bill Cassidy, MD (R-LA) who introduced the bills, they “both work to lower the price patients pay for their prescriptions” by increasing competition.

The Advancing Education on Biosimilars Act will create educational materials for health care providers, patients, and caregivers relating to biological products, including biosimilars and interchangeables.  The materials will explain key regulatory terms to help people better understand how biosimilars and interchangeables are developed and regulated.  They will also include relevant clinical considerations for prescribers, explain the adverse event reporting process, and clarify the relationship between a reference product, a biosimilar, and an interchangeable.  The Act will advance continuing education programs for healthcare providers relating to the prescribing of biological products, including biosimilars and interchangeables, and the relevant clinical considerations.

The Ensuring Innovation Act changes the way the FDA determines whether a new drug qualifies for the five year new chemical entity (NTE) exclusivity.  It amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by replacing the definition of “active ingredient (including any ester or salt of the active ingredient)” with “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations).”  According to the bill’s sponsors, this change closes loopholes that allowed drugmakers to gain market exclusivity on minor modifications that did not represent true innovations, which delayed cheaper generics from entering the market.  In addition, the Act requires FDA advisory committee review of biological products prior to approval, or an explanation as to why an advisory committee meeting was not needed.


    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website ( Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.


    The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

    Subscribe for Future Updates