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Assessing new-to-market biologics and biosimilars

Strategies for ensuring access to clinically appropriate insulin or other medications


Joshua Fredell, PharmD, Vice President and Head of PBM & Specialty Product Innovation


Expenses for those with diabetes add up. A patient with diabetes may have up to twice the health care costs as someone without diabetes1, and the cost of insulin has skyrocketed over the past several years without material changes to the product.2

Whether a plan member with diabetes needs insulin or a different medication, our formularies focus on providing a low net cost strategy while ensuring clinical appropriateness. To complement our formulary strategies, we use weekly new-to-market (NTM) reviews to assess new drugs, whether they are biologic, biosimilar, traditional brand or generic drugs.

When evaluating NTM biosimilar products for inclusion on our formulary, we review clinically appropriate alternatives in their therapeutic class. Sometimes the lowest net cost product is the reference brand and sometimes it is the biosimilar. Of biosimilars that have launched, we have several preferred biosimilars on our commercial template formularies.

A generic drug uses the same active ingredients as the branded drug and is considered the reference product’s bioequivalent3 and is interchangeable. A biosimilar, which is highly analogous to a reference product, may or may not be interchangeable with its biologic reference product. To be considered interchangeable, the biosimilar must meet additional conditions during the U.S. Food and Drug Administration (FDA) approval process.4


Depending on each state’s laws, a pharmacist may be able to substitute an interchangeable biosimilar for the reference product at the pharmacy without a prescriber or member request.5 If a biosimilar is not interchangeable, physician and member must agree to a change in the prescription from the reference product. 

The FDA has approved 30 biosimilars6 but, until this summer, none were approved as interchangeable. An exciting milestone in biosimilar development was reached in July when the FDA granted interchangeable status to insulin glargine-yfgn, currently marketed as Semglee. Semglee is a biosimilar insulin product initially approved in 2020 that is used to treat adults and pediatric patients with Type 1 diabetes mellitus and adults with Type 2 diabetes mellitus.7


  • The FDA has approved 30 Biosimilars
  • 1 is approved as interchangeable


Insulin glargine-yfgn is both a biosimilar to and interchangeable with its reference product Lantus (insulin glargine). While insulin glargine-yfgn is the first interchangeable biosimilar product approved in the United States for the treatment of diabetes, it is also the first interchangeable biosimilar product approved by the FDA.8

The manufacturer expects to launch the product before the end of 2021.9 We will continue to monitor as more information becomes available.10

Approval of interchangeable biosimilars, such as insulin, can provide effective additional products for consideration by providers, creating opportunities for us to drive lowest net cost for our clients and make drugs more affordable for members.

Our template formularies include new-to-market product reviews and regular evaluations to address changes in the rapidly evolving marketplace.


The source for data in this document is CVS Health Enterprise Analytics, unless otherwise noted.

This document contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with CVS Health.

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