Conclusions from The Next Drugs: An Atlantic Policy Briefing on Biosimilars
Contact: Steve Arnoff 202.249.7113
The GPhA Biosimilars Council partnered with Atlantic Media on a breakfast event, The Next Drugs: An Atlantic Policy Briefing on Biosimilars. Speakers included Sen. Bill Cassidy (R-LA), Representative Gene Green (D-TX), experts from Amgen, The American Diabetes Association, Foley and Lardner, LLP, and Biosimilars Council member Hillel Cohen, Executive Director for Scientific Affairs at Sandoz. A robust dialogue on key biosimilars policy issues captivated a standing room only crowd.
Three conclusions were clear:
1. Experts will need more biosimilars education.
As Christine Simmon, Executive Director, Biosimilars Council and GPhA Senior Vice President, Policy and Strategic Alliances mentioned in her opening remarks, “if the real estate mantra is: location, location, location; the Council mantra for biosimilars is education, education, education!” Doctors and pharmacists have to be able to trust the science that enables FDA to approve biosimilars as safe, effective alternatives to costly brand biologic drugs. The Biosimilars Council is the leading industry source for education on these medicines. To that end, the Biosimilars Council authored an easy-to-read primer and the FDA has education modules available online.
2. Manufacturers will benefit from more regulatory clarity.
Pending guidances for key aspects of biosimilar development and approval remain outstanding. Confidence in the scientific principles that inform the safety and efficacy these medicines is crucial and should be reflected in policy development. View more Biosimilar resources
3. Everyone will benefit from biosimilar savings.
Projections for biosimilar savings range from $44 billion to $250 billion over 10 years. The reason for this wide range is simple – the policies that will create the emerging biosimilars market are still being defined. That’s why it is critical to create a framework that encourages competition and helps these medicines realize full potential. A successful environment for biosimilars is one that counters misinformation and recognizes that approved biosimilars are just as safe and effective as their more costly brand biologic counterparts. Policy decisions made today will help realize the promise of biosimilars – expanded access to more affordable medicines and billions of dollars in patient and system savings.
With such high spending on biologic medicines, the potential savings from biosimilars is great. Depending on various factors, including the 10-year period examined, estimates from various economic impact studies pin the projected savings from $44 billion on the low end to as high as $250 billion over the first 10 years that biosimilars are available to patients. (Source: The Next Frontier for Improved Access to Medicines: Biosimilars and Interchangeable Biologic Products)
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GPhA represents the manufacturers and distributors of finished generic pharmaceuticals, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals fill 89 percent of the prescriptions dispensed in the U.S. but consume just 27 percent of the total drug spending.