A new challenger enters the field: FDA approves the first interchangeable biosimilars

A new challenger enters the field: FDA approves the first interchangeable biosimilars
Madeleine Davies, PharmD, M Health Fairview Smiley’s Family Medicine Clinic

Within 2021, the US Food and Drug Administration (FDA) has given the green light for two biosimilars to obtain interchangeable status. The FDA granted the first of these on 28 July 2021 to Semglee® (insulin glargine-yfgn) and the second on 18 October 2021 to Cyltezo® (adalimumab-adbm). With this interchangeable designation, pharmacists will be able to substitute each of these products for their reference biologics - Lantus® (insulin glargine) and Humira® (adalimumab), respectively.

Insulin glargine is a long-acting insulin that is crucial to the regimen of many insulin-dependent patients with diabetes. However, a study published by Herkert et al showed that high costs and copays for this medication resulted in an estimated 25 percent of patients underusing their insulin and obtaining poor glycemic control. It is hoped that the approval of an interchangeable for Lantus® will result in more affordable insulin, but complicated drug prices make it difficult to determine the extent to which patients can benefit. To add to the complication, Biocon, maker of Semglee®, announced the release of both a branded and an unbranded version of insulin glargine-yfgn on 16 November 2021. As of November 2021, RED BOOK Online reports the average wholesale price (AWP) of a 5-pack of the new Semglee® (insulin glargine-yfgn) pens to be $484.85, 95 percent of the AWP of a 5-pack of Lantus® pens at $510.37. In comparison, a 5-pack of insulin glargine (insulin glargine-yfgn) pens has an AWP of $177.58, 35 percent of Lantus® pens, per RED BOOK Online. These two insulin glargine-yfgn will both be interchangeable by pharmacies, though coverage by insurance will be determined on a plan-by-plan basis.

Less is known about the expected price and financial impact of Cyltezo®, the interchangeable for Humira®. Humira® is the number one drug in terms of revenue generation in the US, topping the market at $19.8 million in total sales in 2020, according to an article by Buntz. The AWP of a 2-pack (approximately one month supply) of Humira® 40 mg/0.8 mL is $7,161.82, according to RED BOOK Online. While the expected financial impact of an interchangeable for Humira® is exciting, there are a couple limitations. First, the FDA only approved Cyltezo® in the 40 mg/0.8 mL and 20 mg/0.4 mL formulations. Humira® is available in a higher concentrated 80 mg/0.8 mL pen, which could leave Humira® as the preferred product when higher doses of adalimumab are indicated. Secondly, Boehringer Ingelheim announced in 2019 that Cyltezo® will not be introduced to the US market until 1 July 2023 due to litigation agreements with AbbVie, the maker of Humira®. The FDA’s second interchangeable approval has many implications for patients, pharmacists, and the US market, but it will be another year until these implications are realized.

References:

  1. Active Ingredient: Adalimumab. RED BOOK Online. IBM Micromedex [database online]. Truven Health Analytics/IBM Watson Health; 2021. Accessed November 7.2021. https://www.micromedexsolutions.com
  2. Active Ingredient: Insulin glargine. RED BOOK Online. IBM Micromedex [database online]. Truven Health Analytics/IBM Watson Health; 2021. Accessed November 26, 2021. https://www.micromedexsolutions.com.
  3. Active Ingredient: Insulin glargine-yfgn, recombinant. RED BOOK Online. IBM Micromedex [database online]. Truven Health Analytics/IBM Watson Health; 2021. Accessed November 26, 2021. https://www.micromedexsolutions.com.
  4. Biocon. Biocon Biologics and Viatris Announce Launch of Interchangeable SEMGLEE® (insulin glargine-yfgn) Injection and Insulin Glargine (insulin glargine-yfgn) Injection. https://www.biocon.com/biocon-biologics-and-viatris-announce-launch-of-i.... Published November 16, 2021. Accessed November 26, 2021.
  5. ​​Boehringer Ingelheim. Boehringer Ingelheim announces resolution of Cyltezo patent litigation | boehringer-ingelheim.us. https://www.boehringer-ingelheim.us/press-release/boehringer-ingelheim-a.... Published May 14, 2019. Accessed November 7, 2021.
  6. Buntz B. 50 of 2020’s best-selling pharmaceuticals. Drug Discovery and Development. https://www.drugdiscoverytrends.com/50-of-2020s-best-selling-pharmaceuti.... Published May 14, 2021. Accessed November 7, 2021.
  7. Herkert D, Vijayakumar P, Luo J, et al. Cost-Related Insulin Underuse Among Patients With Diabetes. JAMA Intern Med. 2019;179(1):112-114. doi:10.1001/JAMAINTERNMED.2018.5008
  8. U.S. Food and Drug Administration. FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira. https://www.fda.gov/news-events/press-announcements/fda-approves-cyltezo.... Published October 18, 2021. Accessed November 7, 2021.
  9. U.S. Food and Drug Administration. FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes. https://www.fda.gov/news-events/press-announcements/fda-approves-first-i.... Published July 28, 2021. Accessed November 7, 2021.