Two Bills Aiming to Lower Prescription Drug Costs Await Signatures from Biden

Date: April 19, 2021 | Country: UNITED STATES | Region: NORTH AMERICA | Type: Editors ChoiceBiosimilarPolicy | Keywords: #advancingeducationonbiosimilarsact #biosimilaractionplan 
#biosimilarsforum #education #ensuringinnovationact #fda #generic #innovation #marketexclusivity 
#prescriptiondrug #regulation

PRICENTRIC BRIEF:

  • Two bipartisan pieces of legislation, the Advancing Education on Biosimilars Act and the Ensuring Innovation Act, aimed at lowering prescription drug costs are now awaiting signatures from United States President Joe Biden after clearing Congress, announced Senator Bill Cassidy (R-LA)
  • The Advancing Education on Biosimilars Act requires that educational materials aimed at improving confidence in the safety and efficacy of Food and Drug Administration (FDA)-approved biosimilars be provided to patients and care providers
  • On the other hand, the Ensuring Innovation Act provides clarity for drug exclusivity to prevent awarding market exclusivity to products that do not represent true innovation and delay cheaper generics from entering the market—essentially, it closes loopholes to prevent market exclusivity being awarded for a product that is not truly innovative 

 

THE DETAILS

WASHINGTON, D.C., United States – Two bipartisan pieces of legislation, the Advancing Education on Biosimilars Act and the Ensuring Innovation Act, aimed at lowering prescription drug costs are now awaiting signatures from United States President Joe Biden after clearing Congress, announced Senator Bill Cassidy (R-LA).

The Advancing Education on Biosimilars Act requires that educational materials aimed at improving confidence in the safety and efficacy of Food and Drug Administration (FDA)-approved biosimilars be provided to patients and care providers.

Information to be shared on a biosimilar-specific website would include regulatory details on the approval and classification of biosimilars, as well as their interchangeability with their branded biologic counterparts. Additionally, comparative data for biologics and their biosimilars would be made available, with continuing educational programs established for health care providers.

It is hoped that improved confidence in biosimilars will encourage increased use, thus generating savings in the health care field.

Regarding this Act, Meaghan Rose Smith, Executive Director of the Biosimilars Forum, commented, “Biosimilars are the next generation of generics and how we can tackle the single biggest driver of prescription drug spending. With increased use of biosimilars and better patient access to these life-changing therapies, the U.S. could save $100 billion in the next five years.

Smith added, “The FDA has identified education as an important factor for the successful adoption of biosimilars, recognizing the need to increase public awareness in the Biosimilars Action Plan, and increased education can empower physicians and patients.”

On the other hand, the Ensuring Innovation Act provides clarity for drug exclusivity to prevent awarding market exclusivity to products that do not represent true innovation and delay cheaper generics from entering the market—essentially, it closes loopholes to prevent market exclusivity being awarded for a product that is not truly innovative.

One of the senators who introduced the bill, Senator Roger Marshal (R-KS) said, “As a physician, and now a U.S. Senator, I believe innovation and competition can have a profound impact on driving down the cost of health care,” said Senator Marshall. “The current regulatory landscape unnecessarily delays patient access to FDA-approved generics. Our bipartisan legislation ensures affordable life-saving medicine while preserving innovation for cutting-edge medicine, and I’m pleased we are one step closer to this becoming law.”

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