The New Frontier for Improved Access to Medicines

Policy Maker Learning Track

Biologic medicines are some of the most costly prescriptions administered in the US.

While only two percent of America’s patients use biologics, they account for about 40 percent of prescription drug spending in the U.S. New therapies known as biosimilars offer the potential for tens of billions of dollars in savings for the American health care system, and improve access for patients. Biosimilar, or safe, equally as effective, versions of costly brand biologics are now available in the United States for millions of people suffering from cancer, arthritis, Crohn’s disease, psoriasis and other diseases. Similar to the advent of generic medications more than 35 years ago, biosimilars have the potential to ensure all patients can benefit from advances in biopharmaceutical research.

Over the past few years, great progress has been made in the development and approval of biosimilar products in the United States, the European Union (E.U.) and across the globe. Research advances have yielded safe and effective biosimilars that increase the quality and length of patients’ lives. Today, there are more than 60 biosimilar products approved worldwide and biosimilar medicines have launched in about 80 countries.

This learning track is designed for policymakers. It will discuss:

  • The basics of biosimilar development, including the concepts of safety & sameness and efficacy
  • How biosimilars are developed and made
  • The role of the FDA in biosimilar development
  • The importance of developing a robust biosimilars market in the US

Policymakers are an important stakeholder in creating a robust, competitive biosimilars market in the United States. Through greater understanding and education, we can ensure all patients have access to life-changing biologic medicines.

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