Byooviz Gains Interchangeability Status

Two years after first being approved in the United States, the ranibizumab biosimilar Byooviz from Samsung Bioepis has now gained interchangeability status, putting it on par with Cimerli, which was first approved as an interchangeable biosimilar in August 2022.

There are 2 ophthalmology biosimilars approved in the United States. Both now have interchangeability status.

Image credit: Syda Productions - stock.adobe.com

Byooviz is a biosimilar product of Lucentis, which is marketed by Novartis and Roche, and it was approved as the first ophthalmology biosimilar in the United States in September 2021. The biosimilar is now interchangeable with Lucentis for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Cimerli from Coherus Biosciences is the only other ophthalmology biosimilar in the United States. Cimerli had 12 months’ exclusivity on interchangeability.¹ This month, Formycon, Coherus’ commercialization partner, announced that since launch, Cimerli sales have exceeded 100,000 doses and achieved 25% market share as of August 2023.²

“This is a great achievement and underlines again that biosimilars are an important treatment option for severe retinal diseases,” Stefan Glombitza, PharmD, CEO of Formycon, said in a statement.

A recent study in JAMA Health Forum found biosimilars could act as a possible cost-saving solution in the future for the ophthalmology space.³ Reference aflibercept and ranibizumab are among the costliest Medicare Part D drugs. In the space, bevacizumab is less expensive and used off-label, but while there are bevacizumab biosimilars approved, they are not used off-label in the eye space.⁴

Reference bevacizumab treats neovascular age-related macular degeneration through an injection to the eye; however, the biosimilar has never been tested in the eye and the manufacturers of bevacizumab biosimilars do not advise injecting into the eye because of the lack of scientific proof to support it.

So far, ophthalmologists have generally been slow to switch to biosimilars. A report⁵ published in January 2023 found that ophthalmologists’ comfort and familiarity with biosimilars in 2022 was down compared with 2021. Barriers to biosimilars remain with concerns around comparable safety and efficacy of biosimilars compared with the reference product.

More ophthalmology biosimilars could be coming soon. Regeneron’s Eylea will lose patent protection on May 17, 2024.⁶ In September, the European Commission approved the first aflibercept biosimilar, Yesafili from Biocon Biologics.⁷ Formycon, Celltrion, and Samsung Bioepis are all working on their own aflibercept biosimilars.

Sandoz recently released positive results from the Mylight phase 3 efficacy and safety trial for its aflibercept biosimilar.⁸ The trial successfully showed therapeutic equivalence in mean change of best corrected visual acuity over 8 weeks compared with the reference product.

“This important milestone, confirming therapeutic equivalence of the biosimilar aflibercept with the reference biologic, takes us one step closer to providing patients with a key treatment in an area of high unmet need within ophthalmology,” Claire D’Abreu-Hayling, chief scientific officer, Sandoz, said in a statement. “It also underscores our ability to provide high-quality, affordable biologics to individuals to help the treatment of their disease, and highlights the rich Sandoz pipeline of biologics.”

The company expects to file for regulatory approval for the product in both the United States and the European Union in the coming months.

References

1. FDA approves Coherus’ Cimerli as interchangeable biosimilar to ranibizumab. The Center for Biosimilars^® website. August 3, 2022. Accessed October 24, 2023. https://www.centerforbiosimilars.com/view/fda-approves-coherus-cimerli-as-interchangeable-biosimilar-to-ranibizumab

2. Formycon ranibizumab biosimilar FYB201/Cimerli achieved 25% market share in the United States. News release. Formycon. October 10, 2023. Accessed October 24, 2203. https://www.formycon.com/en/blog/press-release/25-percent-market-share-for-fyb201-in-the-us/

3. Dickson SR, James KE. Medicare part B spending on macular degeneration treatments associated with manufacturer payments to ophthalmologists. JAMA Health Forum. Published online September 8, 2023. doi:10.1001/jamahealthforum.2023.2951

4. Joszt L. Ophthalmologists see promise and peril, but lack familiarity, with biosimilars. The American Journal of Managed Care^® website. July 19, 2022. Accessed October 24, 2023. https://www.ajmc.com/view/ophthalmologists-see-promise-and-peril-but-lack-familiarity-with-biosimilars

5. Joszt L. With 2 biosimilars available, use remains low among ophthalmologists. The American Journal of Managed Care website. January 14, 2023. Accessed October 24, 2023. https://www.ajmc.com/view/with-2-biosimilars-available-use-remains-low-among-ophthalmologists

6. Becker Z. Regeneron’s Eylea scores coveted pediatric exclusivity, extending its market hold by 6 months. FiercePharma website. October 21, 2022. Accessed October 24, 2023. https://www.fiercepharma.com/pharma/regenerons-eylea-scores-coveted-pediatric-exclusivity-giving-top-seller-six-more-months

7. Jeremias S. European Commission approves first aflibercept biosimilar. The Center for Biosimilars® website. September 21, 2023. Accessed October 24, 2023. https://www.centerforbiosimilars.com/view/european-commission-approves-first-aflibercept-biosimilar

8. Sandoz announces positive results from Mylight phase III study for biosimilar aflibercept. News release. Novartis. August 15, 2023. Accessed October 2023. https://www.novartis.com/news/media-releases/sandoz-announces-positive-results-from-mylight-phase-lll-study-biosimilar-aflibercept