Biosimilars

Return to Policy & Issues

With numerous specialty drug patents expiring in the next five years, manufacturers are readying new biosimilars for introduction into the market. By 2020, 12 biologic products with global sales of more than $67 billion could face biosimilar competition. A biosimilar is a biologic product that is approved and judged by the FDA to be highly similar to another FDA-approved biologic product (known as a reference product) and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilars.

Patient advocates and payers anticipate biosimilars will foster competition and deliver increased savings from negotiated discounts. Biosimilars are generally priced about 20 percent below their brand-name counterparts and after several years of competition would be priced as much as 40 percent below the reference product.

Research

Press Releases

Additional Resources

Related Card Stacks

What is a specialty drug?

Specialty drugs are best defined by the full range of each product’s attributes, rather than solely by cost and route of administration.

Learn More

What services do specialty pharmacies provide?

Specialty pharmacy services are designed for a small, but growing population of patients with relatively complex and chronic diseases that require expensive and challenging drug regimens.

Learn More

Specialty Drug Trends

Complex, innovative, and high-priced specialty drugs are entering the United States health care market at a rapid rate.

Learn More

What is a biosimilar?

With numerous specialty drug patents expiring in the next five years, manufacturers are readying new biosimilars for introduction into the market.

Learn More