On March 7,2022, Teva Pharmaceuticals announced the launch of the first generic version of REVLIMID® (lenalidomide) in the US (https://www.tevapharm.com/news-and-media/latest-news/teva-announces-launch-of-a-first-generic-version-of-revlimid-lenalidomide-capsules-in-the-u.s/), with dosages available at 5mg, 10mg, 15mg, and 25mg capsules. 

This announcement has led to considerable interest and many questions from the myeloma community. The main questions revolve around the costs of the generic lenalidomide, but there were also questions about the generic version's efficacy and potential side effects compared to the brand product, Revlimid.

What we know right now

• The amount of generic lenalidomide currently available is expected to be volume-restricted and to increase slowly over time, until the volume restrictions are removed on January 31, 2026 (https://ir.celgene.com/press-releases-archive/press-release-details/2019/Celgene-Settles-US-REVLIMID-Patent-Litigation-with-Alvogen/default.aspx). 

Understanding Generic Drugs: Safety and Efficacy

• The volume-limited selling of generic lenalidomide is now allowed to occur (after March 2022) contingent upon approval of an abbreviated New Drug Application. Reports indicate that FDA approval was obtained in 2021 (https://www.fda.gov/drugs/drug-and-biologic-approval-and-ind-activity-reports/2021-first-generic-drug-approvals) by two pharmaceutical companies: Natco Pharma Ltd. (working with Teva) on May 21, 2021; and Dr. Reddy’s Laboratories Ltd. on October 14, 2021. This FDA approval is important for patients because generics go through a rigorous review process. The FDA requires that a generic product must provide the same clinical benefit and safety as the brand product (https://www.fda.gov/drugs/generic-drugs/generic-drug-facts) (Revlimid, in this case). 
• Teva is primarily a drug supplier selling lenalidomide to wholesalers, who then sell to specialty and retail pharmacies
• This means that the pharmacies are the main source of pricing information for patients.

• Availability of generic lenalidomide varies from state to state. The way the prescription is written will allow substitution of generic lenalidomide for the brand Revlimid, or specification of one over the other. In some states, if no selection is made, the patient can choose.
• For patients with commercial insurance, they can go to the TEVA GENERICS site (https://www.tevagenerics.com/product/lenalidomide-capsules)) and access a co-pay card. However, it is important to note that generic lenalidomide is not yet on insurance company formulary lists.

• The standard Risk Evaluation and Mitigation Strategy (REMS) (https://www.lenalidomiderems.com/) questionnaire program will continue to be managed by BMS and will be required for prescriptions to be filled in the usual fashion.

What we do not know: The Impact on Cost and Patient Access

• As of now, we DO NOT know yet what the cost of generic lenalidomide for patients will be, versus the brand product, Revlimid.

• Right now, patients with commercial insurance can apply for a co-pay card, with an annual benefit of $15,000 and a $10 co-pay cost per prescription for brand Revlimid. Thus, it seems unlikely that the cost of generic lenalidomide will be significantly less.
• For Medicare patients, the co-pay costs for Revlimid could end up being in the $11,000 or higher range/year, depending upon an individual’s Part D plan and whether they are eligible for grants from co-pay assistance foundations. It’s not clear yet if or how this changes with generic lenalidomide. 

Navigating the Transition: What Patients Should Do

Our IMF InfoLine Coordinator, Judy Webb has been diligently researching for more definitive information about the pricing of generic lenalidomide. It seems that we will only be able to find out the cost when patients start picking up and paying for generic lenalidomide prescriptions. 

It is also still unknown if there are cost savings for wholesalers and/or pharmacies but if so, then, insurance formularies could make the switch over time. 

This summary will be updated as more information becomes available. Meanwhile, any feedback from patients who have been prescribed generic lenalidomide will be greatly appreciated. If you have been prescribed generic lenalidomide and want to share your experience with the IMF, please email [email protected]. (mailto:[email protected])

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