Seven questions about biosimilars

By Sean McGowan

Introducing specialty physician practices to this innovative safe, effective, and less costly drug class
What is a biosimilar?
A biosimilar is a biologic product that is highly similar—yet not identical—to a reference product. Before a biosimilar goes to market, its manufacturer must conduct studies to show it is highly similar to its reference product.As of September 2021, there have been 20 biosimilars launched in the U.S.2
Are biosimilars safe and effective?
Biosimilar products go through a rigorous FDA approval process to make sure they are safe, pure, and effective. For FDA approval, the manufacturer must demonstrate that the biological product is highly similar and has no clinically meaningful difference between it and the reference product.1

What is the difference between a biosimilar and a generic?
Biosimilars are not generics. Generics are exact copies of synthetic pharmaceuticals, and the active ingredients must be the same as a brand name drug. Biosimilars are copies of biologics, which are medications made with living cells. They can have slight differences in clinically inactive components.3

How do biosimilars support access, choice, and value?
Biosimilars are often cheaper for specialty physician practices than their reference products. Medicare supports the use of biosimilars and reimburses for them at rates competitive to originator products.Biosimilars can also save patients money as they often pay less out-of-pocket.5

What is interchangeability?

Biosimilars that have been approved by the FDA for interchangeability can be substituted for without the intervention of the healthcare professional, in a process known as pharmacy-level substitution. This is subject to state laws.6As of November 2021, two biosimilars—Semgleeand Cyltezo7have the interchangeable designation.

What biosimilars might matter to specialty physicians?
For rheumatology and gastroenterology practices the Infliximab market has three launched biosimilar products: Inflectra, Renflexis, and Avsola. All three reference REMICADE. RITUXAN has three biosimilar products that reference it: Truxima, Ruxience, and Riabni.2 Those products would also be of interest to general infusion centers.

For retina/ophthalmology practices, the first LUCENTIS biosimilar, Byooviz, was approved by FDA on September 17, 2021. Byooviz (ranibizumab-nuna) is expected to launch in June 2022.8 Beyond this, the retina/ophthalmology pipeline is in a promising place. Three other biosimilars that reference LUCENTIS are in the manufacturer development pipeline, as are eight that reference EYLEA.

Also of interest, Outlook Therapeutics is conducting clinical trials on a formulation of BEVACIZUMAB that treats retinal diseases.9 Roche is seeking FDA approval of a port delivery system for RANIBIZUMAB. Its study indicated a refillable implant could be alternative to LUCENTIS by delivering continual doses of anti-VEGF therapy.10

For general medicine practices, one exciting development was the launch of Semglee, the first approved biosimilar in the insulin space. It references LANTUS. Semglee will become the first biosimilar to launch with interchangeability in the United States. It is expected to launch in late 2021.2

Where can physicians who are new to biosimilar therapies learn more?
Read the biosimilars basics whitepaper to increase your understanding of these products.
Download the biosimilar pipeline report to visualize both the current landscape and potential for this marketplace.  

Reach out to your account manager with more questions about adding biosimilars to your specialty physician practice or for access to the materials listed above.

1. US Food and Drug Administration. What is a Biosimilar? Accessed 14 September 2021. Available online at:
2. McGowan, Sean. Biosimilars pipeline report: A guide for understanding the growing market. AmerisourceBergen. 1 August 2021. Accessed 14 September 2021. Available online at:
3. US Food and Drug Administration. Biosimilar and Interchangeable Products. 23 October 2017. Accessed 14 September 2021. Available online at:
4. Hagen, Tony. CMS Payment Policy Plays a Role in Biosimilar Uptake. Center for Biosimilars. 30 January 2020. Accessed 14 September 2021. Available online at
5. Winegarden, Wayne. Promoting Biosimilar Competition to Reduce Patients’ Out-of-Pocket Costs.  Pacific Research Institute. March 2020. Accessed 14 September 2021. Available online at:
6. US Food and Drug Administration. Biosimilar and Interchangeable Biologics: More Treatment Choices. 12 October 2021. Accessed 3 November 2021. Available online at:
7.  US Food and Drug Administration. FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira. 18 October 2021. Accessed 16 November 2021. Available online at:
8. Biogen. FDA Approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11), LUCENTIS® Biosimilar (ranibizumab-nuna). 20 September 2021. Accessed 20 September 2021. Available online at:
9. Davio, Kelly. Outlook Therapeutics Reaches Agreement With FDA on Special Protocol Assessments for ONS-5010. The Center for Biosimilars. 19 December 2019. Accessed 12 November 2021. Available online at
10. Taylor, Nick Paul. FDA accepts Roche’s 6-month Lucentis implant for priority review. Fierce Pharma. 28 June 2021. Accessed 12 November 2021. Available online at:

About the Author

Sean McGowan

Senior Director, Biosimilars
View Bio