Biosimilars Handbook

Medical Professional Learning Track

It is an exciting time in the advancement of biosimilar technology and treatments.

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.

The role of biologic drugs in the health care system is expanding—while only two percent of America’s patients use biologics, they account for about 40 percent of prescription drug spending in the U.S. Biosimilars offer the potential for tens of billions of dollars in savings for the American health care system, and improve access for patients. Biosimilar 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.

This learning track is designed for medical professionals. 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

Medical professionals have a role to play in advancing the biosimilar 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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