The Wait Is Over: 8 Adalimumab Biosimilars Launching in the US in July

The wait for adalimumab biosimilars has been long due to successful patent litigation, but 7 years after the first was approved, the wave of competitors for the reference product Humira, is finally here. Given that Humira has raked in $200 billion over 20 years¹ and was the top-selling drug in the world until Pfizer and BioNTech’s COVID-19 vaccine dethroned Humira in 2021,² competition has been eagerly awaited by the United States.

For nearly 6 months there has only been 1 adalimumab biosimilar available on the US market, but in July the competition is going to ramp up with 8 additional biosimilars poised to launch (Table).

Interchangeable Biosimilars

However, 1 of the 8 set to hit the US market in July will have an advantage: Cyltezo (adalimumab-adbm) from Boehringer Ingelheim is currently the only adalimumab biosimilar with interchangeability.

The product was first approved in October 2021 as the second interchangeable biosimilar approved in the United States³; the first interchangeable biosimilar was Semglee (insulin glargine-yfgn), which the FDA approved in July 2021.⁴

While Cyltezo is currently the only interchangeable adalimumab biosimilar, there may be more to come as Hadlima and Abrilada will likely be submitted to the FDA to receive the designation. In addition, AVT02, from Alvotech, is under review with the FDA for both approval and interchangeability. However, AVT02’s approval has been delayed with 2 complete response letters⁵ related to deficiencies at the manufacturing facility during the FDA’s inspection.

Interchangeability has been a source of controversy in the United States. It is a regulatory designation given by the FDA to biosimilars that have gone through switching trials, which cost the manufacturers additional time and money. However, there is concern that the designation may lead some to believe interchangeable biosimilars are superior to those without the designation, which is not accurate.⁶

The interchangeability designation is unique to the United States; in comparison, European countries consider any biosimilar automatically interchangeable.

When a biosimilar has the interchangeability designation in the United States, pharmacists can switch out the prescribed reference product for the biosimilar without needing the physicians’ permission, depending on state laws. While every state has passed a law on interchangeability, these laws vary.⁷ A total of 36 states require pharmacists notify patients and providers first before switching to a biosimilar, while 4 states (Alabama, Indiana, South Carolina, and Washington) have restricted interchangeability.⁷

Formulary Decisions

Optum Rx, the pharmacy benefit manager (PBM) of UnitedHealth Group, just recently announced that it was adding Cyltezo and Hyrimoz to its formulary.⁸ In November 2022, the PBM had announced it would include Amjevita and 2 other, yet to be named, biosimilars.⁹ All 3 biosimilars are included at parity with Humira.

“As an industry leader driving competition and biosimilar access, we are bringing unprecedented choice and value in this highly utilized but historically very expensive drug class,” Heather Cianfrocco, CEO, Optum Rx, said in a statement.⁸ “PBMs have a responsibility to leverage competition to lower cost and create choice. Access to new biosimilars and their available list price options provides physicians, clients, and patients with affordable treatment options.”

Earlier in June, SmithRx announced it was making Yusimry available for less than 90% of Humira’s list price through a partnership with the Mark Cuban Cost Plus Drug Company.¹⁰ Both Prime Therapeutics and Cigna Pharmacy both said they would include adalimumab biosimilars as preferred products at the same position as Humira.¹¹

References

1. Walker J, Gorenstein D. AbbVie’s blockbuster drug Humira finally loses its 20-year, $200 billion monopoly. NPR. January 31, 2023. Accessed June 28, 2023. https://www.npr.org/sections/health-shots/2023/01/31/1152513058/abbvies-blockbuster-drug-humira-finally-loses-its-20-year-200-billion-monopoly

2. Dunleavy K. The top 20 drugs by worldwide sales in 2021. FiercePharma. May 31, 2022. Accessed June 28, 2023. https://www.fiercepharma.com/special-reports/top-20-drugs-worldwide-sales-2021

3. FDA approves Cyltezo, the first interchangeable biosimilar to Humira. News release. October 18, 2021. Accessed June 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-cyltezo-first-interchangeable-biosimilar-humira

4. FDA approves first interchangeable biosimilar insulin product for treatment of diabetes. News release. July 28, 2021. Accessed June 28, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-insulin-product-treatment-diabetes

5. Jeremias S. FDA issues another CRL for Alvotech’s adalimumab biosimilar. The Center for Biosimilars®. April 14, 2023. Accessed June 29, 2023. https://www.centerforbiosimilars.com/view/fda-issues-another-crl-for-alvotech-s-adalimumab-biosimilar

6. Jeremias S. What's holding up biosimilar uptake? Misconceptions, misaligned incentives, panelists say. The Center for Biosimilars. January 26, 2022. Accessed June 29, 2023. https://www.centerforbiosimilars.com/view/what-s-holding-up-biosimilar-uptake-misconceptions-misaligned-incentives-panelists-say

7. Jeremias S. The age of adalimumab is upon us: How stakeholders can prepare. The Center for Biosimilars. June 28, 2023. Accessed June 29, 2023. https://www.centerforbiosimilars.com/view/the-age-of-adalimumab-is-upon-us-how-stakeholders-can-prepare

8. Optum Rx expands choice, improves affordability for patients with two additional Humira biosimilars. News release. June 23, 2023. Accessed June 29, 2023. https://www.unitedhealthgroup.com/newsroom/2023/2023-06-23-optum-rx-expands-choice-humira-biosimilars.html

9. Myshko D. OptumRx to cover Amgen’s biosimilar of Humira. Formulary Watch®. November 17, 2022. Accessed June 29, 2023. https://www.formularywatch.com/view/optumrx-to-cover-amgen-s-biosimilar-of-humira

10. Joszt L. SmithRx to offer adalimumab biosimilar Yusimry at 90% discount to Humira. The American Journal of Managed Care. June 14, 2023. Accessed June 29, 2023. https://www.ajmc.com/view/smithrx-to-offer-adalimumab-biosimilar-yusimry-at-90-discount-to-humira

11. Joszt L. PBMs announce 2023 coverage plans for adalimumab biosimilars. AJMC.com. January 1, 2023. Accessed June 13, 2023. https://www.ajmc.com/view/pbms-announce-2023-coverage-plans-for-adalimumab-biosimilars