Sandoz resolves US aflibercept biosimilar patent litigation

Sandoz resolves US aflibercept biosimilar patent litigation

In a significant move that underscores the growing competition in the biosimilar market, Sandoz has successfully resolved its patent litigation with Regeneron and Bayer over the launch of its aflibercept biosimilar, ABP 938. This resolution paves the way for the biosimilar to enter the US market, potentially enhancing access to anti-vascular endothelial growth factor (VEGF) therapy for patients with neovascular age-related macular degeneration (nAMD).

The patent dispute, which involved Regeneron and Bayer, had previously blocked Sandoz from launching its biosimilar. However, Sandoz has now secured regulatory approval for ABP 938, which demonstrated comparable efficacy, safety, and immunogenicity to the reference product aflibercept (Eylea) in a multinational randomized trial [3]. The trial, conducted on patients with nAMD, confirmed that ABP 938 is an effective and safe alternative to Eylea.

The resolution of this litigation is a significant milestone for Sandoz and the biosimilar industry. It follows a trend of increasing regulatory approvals and market launches for biosimilars, driven by the need to reduce healthcare costs and expand treatment options. The success of biosimilars like ABP 938 is expected to have a positive impact on patient access to critical therapies, particularly for conditions where the reference product is expensive and widely used.

Moreover, this resolution aligns with broader trends in the biosimilar market, where companies are increasingly focusing on innovative strategies to enhance access and reduce costs. For instance, MedImpact Holdings has announced plans to provide access to an unbranded ustekinumab biosimilar, aiming to bypass traditional supply chain costs and offer a more affordable treatment option [2].

The market for biosimilars remains dynamic, with ongoing challenges in market entry and access. However, the successful resolution of this patent litigation is a step forward in addressing these challenges and promoting the adoption of biosimilars. As the industry continues to evolve, investors and financial professionals can expect to see more developments in this area, driven by the growing demand for cost-effective healthcare solutions.

References
[1] https://www.centerforbiosimilars.com/view/patients-with-namd-maintain-vision-on-aflibercept-biosimilar-abp-938
[2] https://www.lawyerly.com.au/regeneron-bayer-lose-bid-to-block-sandoz-from-launching-eylea-biosimilar/
[3] https://www.centerforbiosimilars.com/view/patients-with-namd-maintain-vision-on-aflibercept-biosimilar-abp-938