Biosimilars and Cancer

Biosimilars represent the potential for significant savings, while also offering increased access to cost-sensitive patients.


Cancer medications can cost more than $10,000/month8


6 of the top 10 drugs by spend in Medicare Part B are originator cancer biologics9

$10 BN

Originator cancer biologics cost patients and payers more than $10 billion/year10

Biosimilars represent an opportunity for significant savings for cancer care

Streamlining Regulation

Biosimilar development and approval can be a lengthy and costly process, sometimes taking up to ten years and $200 million for a single biosimilar to reach approval11. A large part of this resource burden is driven by regulatory requirements, particularly those that require differentiated approaches in various countries. Streamlining regulatory requirements for biosimilar development, approval, and post-approval maintenance has the potential to speed access to biosimilars and improve future biosimilar competition.

The U.S. FDA has made great progress in reviewing and approving biosimilar medicines since the Biologics Price Competition and Innovation Act (BPCIA) was passed. As of March 2021, there have been 29 biosimilars approved by the FDA for 9 molecules. The FDA has also provided substantial guidance to industry on many aspects of biosimilar development and approval.

Additionally, the FDA has been a vocal champion for public trust in biosimilar medicines, through the Biosimilars Action Plan and education initiatives targeting healthcare providers and patients to ensure the trusted voice of the FDA reaches those who stand to gain the most from acceptance of biosimilar medicines.

FDA Guidance on Biosimilars

FDA Biosimilars Action Plan

FDA Biosimilar Education Initiatives

Biosimilars and interchangeable products meet the FDA’s high standard for approval. These standards should assure health care providers that they can be confident in the safety and effectiveness of biosimilars and interchangeable product, just as they would be for an FDA-approved reference product.

Food and Drug Administration