FDA Approved Biocon Biologics Yesafili for Ophthalmology treatment

Introduction:

Biocon Biologics Ltd (BBL), a leading global biosimilars company and subsidiary of Biocon Ltd, has achieved a significant milestone with the U.S. Food and Drug Administration (US FDA) approving its first-to-file application for Yesafili™ (aflibercept-jbvf). Yesafili™, an interchangeable biosimilar aflibercept, marks a breakthrough in ophthalmology treatment, offering hope to millions suffering from various eye conditions.

Approximately 19.8 million Americans are living with age-related macular degeneration (AMD). In 2023, U.S. sales of aflibercept reached around $5.89 billion.

Key Highlights:

Indications: Yesafili™ is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), and diabetic retinopathy (DR).

Comparison to Reference Product: Yesafili™ has been demonstrated to be highly similar to its reference product, EYLEA® (aflibercept), in terms of quality, safety, and efficacy.

Expansion into the U.S. Market: This approval marks Biocon Biologics’ entry into the ophthalmology therapeutic area in the United States, following successful approvals in Europe and the United Kingdom.

Patient Impact: With an estimated 19.8 million Americans living with age-related macular degeneration (AMD), Yesafili™ offers a new treatment option for patients in need.

Interchangeability: Yesafili™ is an interchangeable product, meaning it can be expected to produce the same clinical result as the reference product, with no greater risk when alternating between the two.

About YESAFILI:

Yesafili™ (aflibercept-jbvf) has undergone rigorous testing and analysis to confirm its similarity to EYLEA® (aflibercept). Clinical studies have demonstrated comparable pharmacokinetics, safety, efficacy, and immunogenicity between Yesafili™ and its reference product.

Warnings and Precautions:

Yesafili is contraindicated for patients with ocular or periocular infections, active intraocular inflammation, or hypersensitivity to aflibercept.
Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections.
Patients and caregivers should promptly report any signs or symptoms of these conditions for appropriate management.
Increases in intraocular pressure can occur within 60 minutes of an injection.
Additionally, there is a potential risk of arterial thromboembolic events with intravitreal use of VEGF inhibitors.

Expert Insights:

Shreehas Tambe, CEO & Managing Director of Biocon Biologics Ltd., emphasizes the significance of this approval in expanding their portfolio into ophthalmology. At the same time, Matt Erick, Chief Commercial Officer of Advanced Markets, highlights the importance of biosimilars in making healthcare more accessible.

Conclusion:

The approval of Yesafili™ represents a major advancement in the field of ophthalmology, offering patients and healthcare providers a new, high-quality treatment option for various eye conditions. With Biocon Biologics’ commitment to delivering science-driven medicines, this milestone reinforces its position as a leader in the biosimilar industry.