Biocon Biologics to shake up U.S. eye drug market with Yesafili biosimilar after Regeneron settlement

How is Biocon Biologics planning to enter the U.S. ophthalmology market with Yesafili?

Biocon Biologics Limited, the biosimilars arm of Biocon Limited, has secured a significant breakthrough in the U.S. ophthalmology space with a confirmed market entry date for Yesafili™, an interchangeable biosimilar to Eylea® (aflibercept). This development follows a settlement and license agreement with Regeneron Pharmaceuticals, the reference product’s marketer, which clears the path for commercializing Yesafili in the United States from the second half of 2026—or earlier under specified conditions.

The U.S. launch approval marks a strategic advancement for Biocon Biologics, which has steadily positioned itself as a key global player in biosimilars. The agreement with Regeneron also led to the dismissal of litigation pending before the United States Court of Appeals for the Federal Circuit and the U.S. District Court in West Virginia. While the financial terms of the settlement remain confidential, the implications for the competitive dynamics in the anti-VEGF biologics market are significant.

Yesafili is a biosimilar version of aflibercept, a VEGF inhibitor used to treat various vision-impairing conditions, including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). Eylea, marketed by Regeneron and Bayer, has been one of the most dominant therapies in this segment globally, generating billions in revenue annually since its launch in 2011.

Why is the U.S. FDA’s designation of Yesafili as interchangeable so significant?

Yesafili was approved by the U.S. Food and Drug Administration in May 2024 as an interchangeable biosimilar, a classification that enables pharmacists to substitute it for the originator product—Eylea—without consulting the prescribing physician. This is a crucial competitive advantage in the biosimilars space, where market share often depends on prescriber trust and payer access.

The interchangeable designation followed evidence from the Phase 3 INSIGHT clinical trial, which showed no clinically meaningful differences between Yesafili and Eylea in pharmacokinetics, efficacy, safety, and immunogenicity among patients with diabetic macular edema. The FDA’s decision indicates that patients switching between Eylea and Yesafili are unlikely to experience diminished treatment outcomes, a barrier that typically delays biosimilar uptake in specialty therapies.

For Biocon Biologics, this milestone positions Yesafili as the first interchangeable biosimilar aflibercept filed in the U.S., reinforcing its technical and regulatory leadership. It also underscores the company’s capability to advance complex biologics through rigorous development and regulatory processes.

How does the settlement with Regeneron impact Biocon Biologics’ expansion strategy?

The timing of this settlement aligns with Biocon Biologics’ broader strategy to expand its biosimilar footprint in regulated markets, especially the United States, where the cost of biologic therapies remains a major concern for patients and payers. This settlement not only allows Biocon Biologics early entry into a high-value market but also pre-empts lengthy litigation that could have delayed product launch.

This move is consistent with Biocon Biologics’ prior efforts to resolve patent disputes constructively. In Canada, the company had already reached a separate agreement with Bayer and Regeneron to enter the market with Yesafili no later than July 2025. That launch will precede the U.S. entry and serve as an operational and commercial testbed for the North American market.

Company leadership, including CEO Shreehas Tambe, emphasized that the agreement reinforces Biocon Biologics’ mission of improving access to affordable, high-quality treatments. The settlement enhances the company’s ability to challenge incumbent players in therapeutic areas where cost remains a limiting factor for patients.

What clinical indications will Yesafili target, and what are the safety considerations?

Yesafili has been approved for a wide range of retinal and macular conditions, all of which are currently treated with aflibercept injections. These include neovascular or “wet” age-related macular degeneration, macular edema following retinal vein occlusion (both branch and central RVO), diabetic macular edema, and diabetic retinopathy. These diseases can cause progressive vision loss, particularly in elderly or diabetic patients, and Eylea has been a primary treatment for years.

Like its reference product, Yesafili is administered via intravitreal injection. The prescribing information highlights known risks associated with anti-VEGF therapies, such as endophthalmitis, increases in intraocular pressure, and arterial thromboembolic events. Biocon Biologics has included these warnings consistent with regulatory guidance, maintaining the same safety profile as the original product.

The ability of Yesafili to match Eylea’s clinical results with no meaningful differences across all pharmacological parameters played a pivotal role in the FDA’s interchangeability decision. This ensures that healthcare providers can confidently use Yesafili as a substitute, particularly in health systems focused on reducing biologics expenditure.

What does this mean for Biocon Biologics’ global biosimilar pipeline?

Yesafili is the tenth biosimilar to be commercialized by Biocon Biologics and expands its portfolio into the ophthalmology space, complementing its presence in diabetology, oncology, and immunology. The company’s pipeline currently includes 20 biosimilars in various stages of development and commercialization. Biocon Biologics’ vertically integrated structure, covering R&D, manufacturing, and commercialization, provides it with control over quality, cost, and speed to market—factors essential to competing in the biosimilar landscape.

Beyond the U.S. and Canada, Biocon Biologics aims to roll out Yesafili in other developed and emerging markets where aflibercept remains a costly therapy. The company’s focus on affordability is backed by scalable global manufacturing facilities and strong quality systems, enabling it to meet regulatory requirements across geographies.

Its broader ESG-driven mission to improve access to critical therapies is reflected in the company’s commercial strategy. By addressing key non-communicable diseases with affordable biosimilars, Biocon Biologics is actively supporting global healthcare equity.

How is Biocon’s stock performing and what is the market sentiment?

Biocon Limited, listed on the Bombay Stock Exchange (BSE: 532523) and the National Stock Exchange (NSE: BIOCON), has seen its stock react positively to recent regulatory wins. On April 11, 2025, shares closed at ₹316.55, reflecting a 3.35% gain driven by the U.S. FDA’s approval of another biosimilar product, Jobevne. This boost came despite the broader market’s mixed sentiment and suggests renewed investor interest in the company’s expanding biologics portfolio.

While the stock is still trading around 21% below its 52-week high of ₹404.60 (January 2025), analysts remain cautiously optimistic. The 12-month median target price stands at ₹386.47, with ratings clustered around ‘Buy’ and ‘Strong Buy.’ The forward Price-to-Earnings ratio of 45.72 suggests the market is pricing in future growth, particularly from high-margin U.S. biosimilar launches like Yesafili.

The sentiment around Biocon Limited appears to be improving in tandem with its regulatory progress and strategic product pipeline. The first-mover advantage with Yesafili in the U.S. ophthalmology market offers a long-term value proposition, provided the company executes effectively on manufacturing, market access, and pricing strategies.

For investors with moderate risk appetite, Biocon presents a viable opportunity to gain exposure to the biosimilar space, especially with increasing U.S. and Canadian market penetration. However, volatility should be expected given sectoral headwinds, pricing pressure, and global regulatory complexities.