New laws address NCE exclusivity, biosimilar education

Regulatory NewsRegulatory News | 26 April 2021 |  By 

Two bipartisan bills aimed at clarifying what constitutes a new chemical entity (NCE) and providing education on biosimilars to consumers and physicians were signed into law by President Joe Biden on Friday.
The first bill, S. 415, also known as the Ensuring Innovation Act, amends the Federal Food, Drug, Cosmetic Act (FD&C Act) to replace the definition of an active ingredient with the active moiety definition used by FDA for the purposes of determining whether a new drug qualifies for five years of NCE exclusivity.
Specifically, the law strikes the phrase “active ingredient (including any ester or salt of the active ingredient)” from the FD&C Act and replaces it throughout with “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations)).”
Sponsors of the bill Sens. Bill Cassidy (R-LA), Tina Smith (D-MN) and Roger Marshall (R-KS) say the bill will prevent drugmakers from gaining exclusivity for minor modifications to products and help to facilitate generic competition.
Both FDA’s interpretation of the exclusivity provisions of the FD&C Act and its definition of active moiety have been subject to legal challenges. A 2019 report by the Congressional Research Service on similar legislation introduced in the previous legislative session found that these changes “would moot questions about the validity of FDA’s interpretation and clarify when chemical entities are sufficiently similar to be considered identical for the purposes of drug approval and exclusivity.”
The bill also extends the requirement for FDA to publish action packages for newly approved drugs within 30 days to apply to new biological products as well. Similarly, the bill requires that FDA convene an advisory committee either to review novel biologicals or to provide a summary of the reasons why it did not refer a new biological product to an advisory committee in the action letter for that product.
The second bill, S. 164, the Advancing Education on Biosimilars Act of 2021, amends the Public Health Service Act to allow FDA to create a website featuring educational materials on biologics and biosimilars aimed at healthcare providers, patients and caregivers.
The bill, introduced by Sens. Maggie Hassan (D-NH) and Cassidy, is intended to facilitate biosimilar uptake by educating healthcare providers and patients about such products and has received praise from biosimilar industry groups.
“Education is a crucial step toward more widespread adoption of safe, effective and more-affordable biosimilar therapies. There is much work to be done in the United States to increase usage of biosimilars, stimulate competition and reduce prices for patients, and we look forward to working with our counterparts at the Food and Drug Administration to inform providers and patients about the benefits that biosimilars bring to the market,” said Christine Simmon, executive director of the Association for Accessible Medicine’s Biosimilars Council.
While the law enables the use of a wide array of educational materials, including webinars, continuing education modules and infographics, it does not provide any specific funding for the creation of such materials.
White Hous


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