#United States #Eylea #Bridgewater #Biocon Biologics #Yesafili

Biocon Biologics Secures Yesafili™ Market Entry in the U.S.

On April 15, 2025, Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, made a pivotal announcement. The company publicized a settlement and licensing agreement with Regeneron that will facilitate the commercial launch of Yesafili™ (aflibercept-jbvf), an interchangeable biosimilar of Eylea® (aflibercept), within the United States. This agreement marks a significant step forward in the biosimilars market, especially for ophthalmology treatments.

Yesafili™ operates by inhibiting vascular endothelial growth factor (VEGF) and has been developed to treat various serious eye conditions, including neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME). This drug is seen as a promising alternative to the reference product, Eylea®, providing patients with similar quality, safety, and efficacy.

Legal Milestones in the Launch

The settlement agreement effectively resolves any pending litigation related to patent US11084865 and allows Biocon to commence marketing Yesafili™ as early as the second half of calendar year 2026, depending on circumstances. Shreehas Tambe, CEO and Managing Director of Biocon Biologics, expressed optimism, stating that this settlement not only propels Biocon Biologics into the ophthalmology field but also amplifies their commitment to providing high-quality, accessible healthcare solutions.

Previously, the U.S. Food and Drug Administration (FDA) granted approval for Yesafili™ in May 2024, and Biocon has also established a similar settlement in Canada, anticipating a launch by July 1, 2025, alongside Bayer Inc. and Regeneron Pharmaceuticals, Inc.

Clinical Background and Approval Process

The approval of Yesafili™ was conducted through a thorough review of clinical studies that affirm its high similarity to Eylea®. In a Phase 3 INSIGHT study featuring subjects with DME, Yesafili™ demonstrated no significant clinical differences when compared to Eylea®. The data collected provided confidence in the drug's pharmacokinetics, safety profile, efficacy, and immune response.

Yesafili™ is indicated for multiple conditions:

• - Neovascular (Wet) Age-Related Macular Degeneration (AMD)
• - Diabetic Macular Edema (DME)
• - Visual impairment due to retinal vein occlusion (RVO)

However, there are associated risks and contraindications. Patients with ocular infections, active intraocular inflammation, or hypersensitivity to aflibercept are cautioned against the use of Yesafili™ due to potential severe ocular side effects, including endophthalmitis and retinal detachment.

Transformational Impact on Healthcare

As Biocon Biologics targets to enhance access to effective treatments, the introduction of Yesafili™ could democratize care for many patients suffering from sight-threatening diseases. By focusing on lowering the cost of biologics without compromising quality, Biocon is positioning itself as a leader in the global biosimilars market.

For over 120 countries, Biocon Biologics is leveraging its capabilities and innovative technologies to ensure that patients have affordable access to essential medications. According to Tambe, this new addition to their portfolio not only embodies their scientific prowess but also highlights their strategic aims of expanding into new therapeutic areas.

For more information about Yesafili™ or to report adverse reactions, healthcare professionals and patients can contact Biocon Biologics through their official channels.

About Biocon Biologics Ltd

Biocon Biologics Ltd is committed to transforming the healthcare landscape by providing innovative, high-quality biosimilars. Leveraging advanced manufacturing processes and research-driven initiatives, Biocon continues to pave the way for affordable therapeutic options that empower patients worldwide.