Sandoz's Strategic Patent Settlement and Its Impact on Biosimilar Market Access and Profitability

The recent resolution of patent litigation between Sandoz and Regeneron marks a pivotal moment for the biosimilar landscape in the U.S. aflibercept market. By securing a settlement in September 2025, Sandoz has cleared a critical legal hurdle for its FDA-approved biosimilar, Enzeevu™, which is now poised for a market launch by the end of 2026 or earlier under specific conditions [1]. This development not only accelerates Sandoz’s entry into a rapidly expanding therapeutic category but also underscores the strategic importance of navigating patent disputes to unlock long-term profitability in a highly contested market.

Market Access: A Competitive Landscape Unfolds

The U.S. aflibercept biosimilar market is becoming increasingly crowded, with multiple players vying for market share. As of 2024, five biosimilars—Enzeevu (Sandoz), Opuviz (Samsung Bioepis), Ahzantive (Formycon), Yesafili (Biocon), and Pavblu (Amgen)—have received FDA approval or are in advanced stages of development [3]. However, patent litigation has delayed the commercialization of several products. For instance, Amgen’s Pavblu launched in 2024 with a 10% price discount relative to Regeneron’s Eylea, setting a benchmark for pricing competition [3]. Sandoz’s Enzeevu, approved in August 2024 and designated as interchangeable with Eylea, now faces a more favorable path to market access following the settlement, potentially allowing it to capture a significant share of the $4.767 billion U.S. aflibercept market [1].

The settlement with Regeneron also differentiates Sandoz from competitors like Biocon, which resolved its litigation in early 2025 but faces a delayed launch until late 2026 [3]. By resolving disputes earlier, Sandoz gains a temporal advantage, enabling it to establish market presence before the full influx of biosimilars. This timing is critical, as the U.S. biosimilar market is projected to grow at a compound annual growth rate (CAGR) of 9.1% from 2026 to 2033, reaching $3.2 billion by 2033 [3].

Profitability: Balancing Pricing Pressure and Market Share

While biosimilars traditionally offer cost savings, pricing strategies vary widely. Amgen’s Pavblu, for example, entered the market with a 10% discount, illustrating the aggressive pricing dynamics in this segment [3]. Sandoz’s profitability will depend on its ability to position Enzeevu competitively. The interchangeability designation—a regulatory distinction allowing automatic substitution by pharmacists—could enhance Enzeevu’s adoption, potentially enabling Sandoz to command a price closer to Eylea than the steeper discounts seen with Pavblu.

However, challenges remain. Regeneron’s litigation strategy, particularly its focus on the ’865 patent covering aflibercept formulation specifications, has historically delayed biosimilar launches [1]. Sandoz’s settlement avoids prolonged legal battles, but ongoing litigation in Australia—where Sandoz plans to launch a different aflibercept biosimilar, Afqlir®—highlights the global complexity of patent disputes [2]. Investors must weigh these regional risks against the U.S. market’s growth potential.

Long-Term Value Creation: Strategic Positioning in a Fragmented Market

Sandoz’s resolution of the Regeneron litigation aligns with its broader strategy to expand its biosimilar portfolio and improve patient access to affordable therapies. The settlement reduces legal uncertainty, allowing the company to focus on commercialization and partnerships with payers and providers. Given the projected $3.2 billion market size for aflibercept biosimilars by 2033 [3], early market entrants like Sandoz are well-positioned to capture a disproportionate share of growth.

Moreover, the global biosimilar market is expected to expand from $34.8 billion in 2024 to $93.1 billion by 2030, driven by cost-conscious healthcare systems and regulatory support [4]. Sandoz’s experience in navigating U.S. patent litigation could serve as a blueprint for future biosimilar launches, reinforcing its reputation as a leader in complex biologics.

Conclusion

Sandoz’s patent settlement with Regeneron represents a strategic win that accelerates Enzeevu’s market entry and strengthens its competitive positioning in the aflibercept biosimilar segment. While pricing pressures and regulatory hurdles persist, the resolution of litigation mitigates a key risk and positions Sandoz to capitalize on the U.S. market’s growth trajectory. For investors, the settlement underscores the importance of legal agility in biosimilar development and highlights Sandoz’s potential to drive long-term value through innovative market access strategies.

Source:
[1] Sandoz reaches agreement with Regeneron, resolving all patent litigation related to its US aflibercept biosimilar [https://www.webdisclosure.com/press-release/sandoz-reaches-agreement-with-regeneron-resolving-all-patent-litigation-related-to-its-us-aflibercept-biosimilar-ioZCGbZ25OH]
[2] Regeneron & Bayer Seek Interlocutory Injunction to prevent AU launch of Sandozs aflibercept biosimilar [https://www.pearceip.law/2025/06/23/regeneron-bayer-seek-interlocutory-injunction-to-prevent-au-launch-of-sandozs-aflibercept-biosimilar/]
[3] Even at 10% Discount, Eylea Biosimilar Pavblu Offers Lower Cost Option [https://aishealth.mmitnetwork.com/blogs/spotlight-on-market-access/even-at-10-discount-eylea-biosimilar-pavblu-offers-lower-cost-option]
[4] Predicting Patent Litigation Outcomes for Biosimilars [https://www.drugpatentwatch.com/blog/predicting-patent-litigation-outcomes-for-biosimilars/?srsltid=AfmBOoqqZZ9im2-YavAVKvcM-3Ia57tb23woG1zVt6w331THrMjMvRMm]