The 19 FDA Approvals in 2024 (Chronologically)
- Simlandi (adalimumab-ryvk)
- Jubbonti (denosumab-bddz)
- Wyost (denosumab-bddz)
- Tyenne (tocilizumab-aazg)
- Selarsdi (ustekinumab-aekn)
- Hercessi (trastuzumab-strf)
- Opuviz (aflibercept-yszy)
- Yesafili (aflibercept-jbvf)
- Bkemv (eculizumab-aeeb)
- Pyzchiva (ustekinumab-ttwe)
- Nypozi (filgrastim-txid)
- Ahzantive (aflibercept-mrbb)
- Epysqli (eculizumab-aagh)
- Enzeevu (aflibercept-abzv)
- Pavblu (aflibercept-ayyh)
- Otulfi (ustekinumab-aauz)
- Imuldosa (ustekinumab-srlf)
- Yesintek (ustekinumab-kfce)
- Stequeyma (ustekinumab-stba)
The biosimilar landscape continues to expand, with 2024 delivering a wave of exciting approvals across multiple therapeutic areas. Last year alone saw the FDA green light some firsts for biosimilars in ophthalmology, oncology, rheumatology, and supportive care, underscoring the growing diversity of options for patients.
While patent litigation clouds the market entry for some products, these 19 FDA approvals may signal a promising future for accessibility and affordability.
The Ophthalmology Space Continues to Grow
One of the biggest space gaining players—that unfortunately will be waiting awhile to play the game—is ophthalmology, with 5 biosimilars referencing Eylea (aflibercept) gaining FDA approval this year. May brought the first approvals, with the FDA issuing 2 approvals on the same day.1 All 5 are approved for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
The 5 products are1-5:
- Yesafili (aflibercept-jbvf) in May 2024
- Opuviz (aflibercept-yszy) in May 2024
- Ahzantive (aflibercept-mrbb) in July 2024
- Enzeevu (aflibercept-abzv) in August 2024
- Pavblu (aflibercept-ayyh) in September 2024
Alas, ongoing patent litigation is leaving these products in limbo for when they will be able to enter the US market.6 Although most are still in progress, biosimilars did receive a win the Amgen case, a federal judge in West Virginia ruled that Eylea maker Regeneron cannot immediately block Amgen's US sales of biosimilar Pabvlu.
Previously, Regeneron accused Amgen of infringing on multiple patents related to Eylea while developing its biosimilar, and Regeneron sought a preliminary injunction to halt Pavblu’s launch. However, US District Judge Thomas Kleeh rejected Regeneron’s request, allowing Amgen to proceed with its plans to bring the biosimilar to market. This particular legal battle is part of Regeneron’s broader efforts to defend Eylea from biosimilar competition, which could significantly impact its market share. Will these biosimilars launch in 2025 like they were anticipated, or will lawsuits push them back to 2032? Only time will tell.
Other Notable Approvals
The year brought more firsts for the US biosimilar market, including approvals for the first denosumab biosimilars and the first eculizumab biosimilars.
In March, the FDA gave the stamp of approval to Wyost/Jubbonti (denosumab-bddz), the first biosimilars to reference Xgeva/Prolia.6 The drugs will be used to treat osteoporosis (Jubbonti) and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors (Wyost). Additionally, they were approved with interchangeability designations, meaning that Jubbonti and Wyost and can be dispensed at the pharmacy in place of Xgeva/Prolia—or each other—without the patient having to wait for a physician to approve the change.
Additionally, the FDA approved the first 2 eculizumab biosimilars: Bkemv (eculizumab-aeeb) and Epysqli (eculizumab-aagh).7,8 Eculizumab biosimilars reference Soliris and, upon launch, will be used to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. These biosimilars will greatly expand access, particularly for patients with paroxysmal nocturnal hemoglobinuria, with about 70% of those treated with reference eculizumab eventually reducing their dose or discontinuing treatment due to high costs.9
Although 2023, may have been the year of adalimumab, 2024 was the year that just kept giving, with an approval for a high-concentration version of Cyltezo (adalimumab-adbm) and another for the long-awaited tenth adalimumab biosimilar, Simlandi (adalimumab-ryvk).10,11
The jury’s still out on whether adalimumab biosimilars are making a major impact on savings or patient access but the growth in pharmacy benefit managers (PBMs) embracing these products and adding them to formulary lists over the past couple years shows promise, with the most recent Samsung Bioepis Biosimilar Market Report showing a 23% uptake across the adalimumab biosimilar space at the end of 2024.12
In the rheumatology space, the FDA granted approval for Tyenne (tocilizumab-aazg), the second biosimilar to reference Actemra (tocilizumab).13 The biosimilar was approved with both intravenous and subcutaneous administration options and will be used to treat rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idopathic arthritis.
Ustekinumab Bonanza Ahead of 2025 Launches
Although 2023 was the year of the first ustekinumab biosimilar approval, 6 biosimilars followed in 202414-20:
- Selarsdi (ustekinumab-aekn) in April
- Pyzchiva (ustekinumab-ttwe) in July
- Otulfi (ustekinumab-aauz) in September
- Imuldosa (ustekinumab-srlf) in October
- Yesintek (ustekinumab-kfce) in November
- Steqeyma (ustekinumab-stba) in December
Noteably, Pyzchiva joins Wezlana (ustekinumab-auub) in the interchangeability club, making them the only 2 ustekinumab biosimilars able to be switched in for the reference product at the pharmacy level.17
These products will be used to treat a range of rheumatic and autoimmune conditions, including plaque psoriasis, psoriatic arthritis, and inflammatory bowel disease, which is an umbrella term for Crohn disease and ulcerative colitis.19
The launches for these products are slated to start at the end of January 2025, after being pushed back from late 2023 due to patent litigation settlements, resulting in every biosimilar manufacturing a Stelara biosimilar competitor postponing their launch.21 Wezlana will launch first, followed by 4 more throughout February, with the rest launching in March.
Oncology and Supportive Care Approvals
Moving on to supportive care, 2024 welcomed the first on-body injector utilizing a pegfilgrastim biosimilar, Udenyca Onbody (pegfilgrastim-cbqv).22 The reference product Neulasta Onpro dominates the pegfilgrastim market, limiting the adoption and cost-saving potential of pegfilgrastim biosimilars. With Udenyca Onbody, patients can receive their pegfilgrastim dose the day after chemotherapy, helping reduce the risk of infection associated with febrile neutropenia. Additionally, a filgrastim biosimilar (Nypozi; filgrastim-txid) was quietly approved in June 2024.23
Lastly, Hercessi (trastuzumab-strf) also joined the ranks, becoming the sixth biosimilar referencing Herceptin (trastuzumab) to be approved in the US.24 The product will be used to treat HER2-positive breast and gastric cancers.
References
1. Jeremias S. FDA approves first Eylea biosimilars. The Center for Biosimilars®. May 20, 2024. Accessed January 21, 2025. https://www.centerforbiosimilars.com/view/fda-approves-first-eylea-biosimilars
2. Jeremias S. Ahzantive receives FDA approval as new Eylea biosimilar. The Center for Biosimilars. July 1, 2024. Accessed January 21, 2025. https://www.centerforbiosimilars.com/view/ahzantive-receives-fda-approval-as-new-eylea-biosimilar
3. Jeremias S. FDA approves biosimilar Enzeevu for eye conditions. The Center for Biosimilars. August 12, 2024. Accessed January 21, 2025. https://www.centerforbiosimilars.com/view/fda-approves-biosimilar-enzeevu-for-eye-conditions
4. Jeremias S. FDA approves Pavblu for retinal conditions. The Center for Biosimilars. September 17, 2024. Accessed January 21, 2025. https://www.centerforbiosimilars.com/view/fda-approves-pavblu-for-retinal-conditions
5. Jeremias S. Eye on Pharma: aflibercept legal drama; PBM, Humira biosimilars; denosumab regulatory review. The Center for Biosimilars. October 15, 2024. Accessed January 21, 2025. https://www.centerforbiosimilars.com/view/eye-on-pharma-aflibercept-legal-drama-pbm-humira-biosimilars-denosumab-regulatory-review
6. Jeremias S. FDA approves first denosumab biosimilars. The Center for Biosimilars. March 5, 2024. Accessed January 21, 2024. https://www.centerforbiosimilars.com/view/fda-approves-first-denosumab-biosimilar
7. Jeremias S. FDA approves first eculizumab biosimilar. The Center for Biosimilars. May 29, 2024. Accessed January 21, 2024. https://www.centerforbiosimilars.com/view/fda-approves-first-eculizumab-biosimilar
8. Jeremias S. FDA approves Epysqli as second Soliris biosimilar. The Center for Biosimilars. July 22, 2024. Accessed January 21, 2025. https://www.centerforbiosimilars.com/view/fda-approves-epysqli-as-second-soliris-biosimilar
9. National Center for Advancing Translational Sciences. Paroxysmal nocturnal hemoglobinuria. Accessed January 21, 2025. https://rarediseases.info.nih.gov/diseases/7337/index
10. Jeremias S. FDA approves high-concentration Cyltezo. The Center for Biosimilars. May 1, 2024. Accessed January 21, 2025. https://www.centerforbiosimilars.com/view/fda-approves-high-concentration-cyltezo
11. Jeremias S. FDA approves 10th adalimumab diosimilar, Simlandi. The Center for Biosimilars. February 24, 2024. Accessed January 21, 2025. https://www.centerforbiosimilars.com/view/fda-approves-tenth-adalimumab-biosimilar-simlandi
12. Jeremias S. Biosimilars drive cost savings and achieve 53% market share across treatment areas. The Center for Biosimilars. January 16, 2025. January 21, 2024. https://www.centerforbiosimilars.com/view/biosimilars-drive-cost-savings-and-achieve-53-market-share-across-treatment-areas
13. Jeremias S. FDA green lights second tocilizumab biosimilar. The Center for Biosimilars. March 7, 2024. Accessed January 21, 2025. https://www.centerforbiosimilars.com/view/fda-green-lights-second-tocilizumab-biosimilar
14. Jeremias S. FDA approves first Stelara biosimilar, Wezlana. The Center for Biosimilars. November 1, 2023. Accessed January 20, 2025. https://www.centerforbiosimilars.com/view/fda-approves-first-stelara-biosimilar-wezlana
15. Jeremias S. Alvotech’s Stelara biosimilar, Selarsdi, receives FDA approval. The Center for Biosimilars. April 16, 2024. Accessed January 21, 2025. https://www.centerforbiosimilars.com/view/alvotech-s-stelara-biosimilar-selarsdi-receives-fda-approval
16. Jeremias S. FDA approves Samsung Bioepis’ Pyzchiva, a biosimilar to Stelara. The Center for Biosimilars. July 1, 2024. Accessed January 21, 2025. https://www.centerforbiosimilars.com/view/fda-approves-samsung-bioepis-pyzchiva-a-biosimilar-to-stelara
17. Jeremias S. Fourth ustekinumab biosimilar, Otulfi, approved in US. The Center for Biosimilars. September 30, 2024. Accessed January 21, 2024. https://www.centerforbiosimilars.com/view/fourth-ustekinumab-biosimilar-approved-in-us
18. Jeremias S. FDA approves Imuldosa, a biosimilar to Stelara. The Center for Biosimilars. October 11, 2024. Accessed January 21, 2025. https://www.centerforbiosimilars.com/view/fda-approves-imuldosa-a-biosimilar-to-stelara
19. Jeremias S. FDA approves Biocon Biologics ustekinumab biosimilar, Yesintek. The Center for Biosimilars. December 2, 2024. Accessed January 21, 2025. https://www.centerforbiosimilars.com/view/fda-approves-biocon-biologics-ustekinumab-biosimilar-yesintek
20. Jeremias S. FDA approves Steqeyma: The seventh Stelara biosimilar. The Center for Biosimilars. December 18, 2024. Accessed January 21, 2025. https://www.centerforbiosimilars.com/view/fda-approves-steqeyma-the-seventh-stelara-biosimilar
21. Jeremias S. Amgen’s Stelara biosimilar delayed until 2025 after settling with J&J. May 29, 2023. Accessed January 21, 2024. https://www.centerforbiosimilars.com/view/amgen-s-stelara-biosimilar-delayed-until-2025-after-settling-with-j-j
22. Jeremias S. FDA approves first biosimilar for Neulasta Onpro. The Center for Biosimilars. January 15, 2024. Accessed January 21, 2024. https://www.centerforbiosimilars.com/view/fda-approved-first-biosimilar-for-neulasta-onpro
23. Biosimilars approvals. The Center for Biosimilars. Updated January 7, 2025. Accessed January 21, 2024. https://www.centerforbiosimilars.com/biosimilar-approvals
24. Jeremias S. FDA approves Henlius’ trastuzumab biosimilar, Hercessi. April 29, 2024. Accessed January 21, 2021. https://www.centerforbiosimilars.com/view/fda-approves-henlius-trastuzumab-biosimilar-hercessi
