Phase 3 study meets primary efficacy endpoint for aflibercept biosimilar in wet AMD
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Key takeaways:
- A phase 3 study of an aflibercept biosimilar met its primary efficacy endpoint.
- Sandoz expects to file for regulatory approval for the biosimilar in the U.S. and EU in the coming months.
An aflibercept biosimilar demonstrated positive results in the treatment of wet age-related macular degeneration in a phase 3 study, according to a press release from Sandoz.
The Mylight phase 3 confirmatory efficacy and safety study investigated the biosimilar in comparison to the reference biologic Eylea (aflibercept, Regeneron), which is indicated for neovascular AMD, diabetic macular edema, macular edema secondary to retinal vein occlusion and other neovascular retinal diseases.
The study met its primary efficacy endpoint of therapeutic equivalence in mean change of best corrected visual acuity from baseline to week 8 between the biosimilar and Eylea.
“Safety, immunogenicity and pharmacokinetics results further confirm that there is no clinically meaningful difference between the products,” Sandoz said in the release.
The company expects to file for regulatory approval for the biosimilar in the U.S. and EU in the coming months.
“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 at Sandoz, said in the release. “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.”
Perspective
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These results are not surprising because there is an extensive preclinical development program in biosimilar studies, and the biologic being tested should have the same therapeutic properties, especially in short-duration studies, as the reference product. Like other biosimilar studies, the primary endpoint for Mylight is at a very short 8-week time point and the enrollment is small, at 460 planned subjects, compared with the 52-week endpoint and 2,419 subjects published in the VIEW studies registering reference aflibercept in neovascular age-related macular degeneration.
Mylight is planned to continue through 48 weeks, and the results of the trial then as well as closely examining real-world use if Sandoz’s biosimilar aflibercept is approved are important to understand before this biosimilar aflibercept is determined clinically exchangeable with reference aflibercept.
There are multiple aflibercept biosimilars under development for possible approval in the U.S., including products from Mylan (MYL-1701P), Amgen (ABP 938), Formycon AG/Bioeq (FYB203) and Samsung (SB15), and ultimately, adoption of these products may reduce the cost of aflibercept. However, we must carefully assess the entirety of data for these products and consider their adoption carefully because our goal as clinicians is to preserve the excellent safety of reference aflibercept treatment and efficiently deliver care to our patients.
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