Zydus Lifesciences Forges Landmark US Alliance for Interchangeable Lucentis® Biosimilar

In a decisive move to dominate the U.S. ophthalmology market, Zydus Lifesciences Limited announced that its subsidiary, Zydus Lifesciences Global FZE, has entered into a strategic partnership with Swiss-based Bioeq AG. The agreement focuses on the exclusive licensing, supply, and commercialization of NUFYMCO® (ranibizumab-leyk), a high-stakes interchangeable biosimilar to the blockbuster drug Lucentis®.

This announcement follows the U.S. Food and Drug Administration (FDA) approval of the Biologics License Application (BLA) for NUFYMCO® on December 18, 2025.

Strategic Significance: The “Interchangeable” Edge

Unlike standard biosimilars, NUFYMCO® has secured an interchangeable designation. This allows pharmacists to substitute the biosimilar for the branded reference product (Lucentis®) without requiring a new prescription from the physician, a regulatory status that typically leads to much faster market adoption.

Key Market Statistics

Target Market: Neovascular (wet) Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), and Retinal Vein Occlusion.
Addressable Market Value: Approximately $210 million in the U.S. (based on IQVIA MAT September 2025 data).
Recent Momentum: This deal comes just weeks after Zydus partnered with Formycon AG for a biosimilar of the cancer immunotherapy drug Keytruda®, signaling a massive pivot toward high-value biologics.

Operational Framework

The partnership is structured as a “split-responsibility” model to leverage the core strengths of both biopharma giants:

Responsibility	Entity In Charge
R&D & Manufacturing	Bioeq AG (Swiss Biopharmaceutical)
Regulatory & Supply	Bioeq AG
Sales & Marketing	Zydus Lifesciences
US Distribution	Zydus Lifesciences

Leadership Perspectives

Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences, emphasized the patient-centric nature of the deal:

“We are happy to collaborate with Bioeq to bring an interchangeable biosimilar to Lucentis® in the US market. This partnership will accelerate our growth while ensuring patients have expanded access to affordable, high-quality ophthalmology care.”

Dr. Thiemo Schreiber, VP Commercial at Bioeq, highlighted the technological achievement:

“NUFYMCO® reflects Bioeq’s advanced expertise in developing complex biosimilars for highly regulated markets. Zydus’ extensive distribution network is the perfect vehicle to broaden treatment options across the US.”