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Drug pricing and innovation are hot topics in Washington right now with several bills making their way through the legislative process, many in a bipartisan fashion. On April 23, 2021, two of these bills were signed into law by President Biden. The first bill, the Ensuring Innovation Act, limits new drug exclusivity, thereby making it easier for generics to enter the market and spur competition. The second bill, the Advancing Education on Biosimilars Act of 2021, is designed to increase the availability of information about biologics and biosimilars in an effort to educate healthcare providers and patients and indirectly increase competition.
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On April 23, 2021, President Biden signed into law The Ensuring Innovation Act (S. 415), which amends the requirements for New Chemical Entity (NCE) and Orphan Drug (ODE) exclusivities under the Federal Food, Drug, and Cosmetics Act (FDCA). The Ensuring Innovation Act exchanges the term “active ingredient” with the term “active moiety” in sections of the FDCA governing NCE and ODE.
The five-year NCE exclusivity provision contained in the FDCA states in part:
If an application submitted under subsection (b) for a drug, no
active ingredient (
including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b), is approved after September 24, 1984, no application may be submitted under this subsection . . . before the expiration of five years from the date of the approval of the application under subsection (b) . . . .
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On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and promoting biosimilars. The Ensuring Innovation Act replaces the term “active ingredient” with “active moiety” in parts of the Federal Food, Drug, and Cosmetic Act (FDCA), effectively endorsing the U.S. Food and Drug Administration’s (FDA) ability to refine the meaning of the term in cases where a new drug’s exclusivity is in question. The Advancing Education on Biosimilars Act, also signed into law Friday, will have the government provide educational materials to medical providers and the general public, aiming to increase confidence in the safety and efficacy of FDA-approved biosimilars. We explain these two bills and their implications below.