In a landmark strategic move set to impact global oncology treatment access, Alvotech and Dr. Reddy’s Laboratories have entered a collaboration and license agreement to co-develop, manufacture, and commercialize a biosimilar version of Keytruda® (pembrolizumab), one of the world’s most commercially successful cancer drugs. The partnership was officially announced on June 5, 2025, by both companies.

This development is expected to make waves in the biosimilar landscape, particularly within the immuno-oncology segment, and reflects the growing need for cost-effective alternatives to expensive biologics that dominate modern cancer treatment.

About Keytruda® (Pembrolizumab)

Keytruda®, developed by Merck & Co., is a monoclonal antibody used in immuno-oncology to treat multiple forms of cancer including melanoma, lung cancer, head and neck cancer, classical Hodgkin lymphoma, and urothelial carcinoma, among others. The drug works by targeting the PD-1 receptor, allowing the immune system to recognize and combat cancer cells more effectively.

In 2024 alone, Keytruda recorded a whopping $29.5 billion in global sales, underlining its critical importance in cancer therapy worldwide.

The Strategic Collaboration: Details and Vision

The agreement outlines that Alvotech and Dr. Reddy’s will:

• Jointly develop and manufacture the biosimilar candidate to Keytruda.

• Share development costs, responsibilities, and commercialization rights, with certain regional exceptions.

• Leverage each other’s strengths in research, regulatory expertise, and market access to accelerate product launch timelines.

This collaboration is a strategic match: Alvotech, known for its global biosimilar expertise and R&D infrastructure, brings manufacturing excellence, while Dr. Reddy’s contributes regulatory know-how, marketing strength, and proven commercial success, especially in emerging markets.

Why This Collaboration Matters

1. Cost-Effective Cancer Treatment: The rising global burden of cancer, combined with the prohibitive cost of biologics like Keytruda, makes biosimilar development a vital solution. This alliance promises to increase accessibility and affordability for patients worldwide.

2. Expanding Oncology Capabilities: Dr. Reddy’s has identified oncology as a key focus area, and this move significantly enhances its footprint in the immuno-oncology space. The addition of pembrolizumab biosimilar to its pipeline strengthens its standing in advanced cancer therapeutics.

3. Market Opportunity and Commercial Potential: With Keytruda’s massive market size, even a single-digit market penetration by a biosimilar can translate into multi-billion-dollar revenues over time. For Alvotech and Dr. Reddy’s, this deal is a long-term strategic investment with strong return potential.

Statements from Company Leadership

Róbert Wessman, Chairman and CEO of Alvotech, stated:

“This agreement demonstrates Alvotech’s ability to leverage its dedicated R&D and manufacturing platform for biosimilars, accelerating the expansion of our pipeline by pursuing growing global markets.”

Erez Israeli, CEO of Dr. Reddy’s, added:

“We are happy to collaborate with Alvotech for the pembrolizumab biosimilar. This demonstrates our ability to develop and manufacture high quality and affordable treatment options for patients worldwide.”

Keytruda Biosimilar: Challenges and Path Ahead

Developing a biosimilar for a complex monoclonal antibody like pembrolizumab is no small feat. Key hurdles include:

• Regulatory Approvals: Getting clearance from FDA, EMA, and other regulators demands rigorous comparability studies, clinical trials, and pharmacovigilance data.

• Manufacturing Complexity: Monoclonal antibodies require high-precision biologic manufacturing platforms, where Alvotech’s facilities will be instrumental.

• Patent Landscape: While certain Keytruda patents are expiring in key jurisdictions, navigating the intellectual property environment will be essential for a smooth launch.

However, both companies’ track record in the biosimilars market, especially Dr. Reddy’s in India and the US, and Alvotech’s global reach, place them in a strong position to overcome these barriers.

Alvotech’s Global Strategy in Biosimilars

Alvotech has been on a growth trajectory, expanding its biosimilar portfolio in recent years. Their pipeline includes biosimilars for:

• Adalimumab (Humira®)

• Infliximab (Remicade®)

• Denosumab (Prolia®/Xgeva®)

This partnership with Dr. Reddy’s aligns with Alvotech’s mission to bring high-quality biologics to markets where cost is a barrier. The collaboration also helps them to diversify market access by teaming up with regionally strong partners.

Dr. Reddy’s Focus on Innovation and Oncology

Dr. Reddy’s Laboratories, already a global name in generics and APIs, has been steadily expanding into complex generics and biosimilars, with a strong focus on oncology, neurology, and immunology.

Their dedicated oncology portfolio includes a mix of:

• Formulations and injectables

• Active pharmaceutical ingredients

• Collaborations for targeted therapies

The addition of a biosimilar to pembrolizumab offers a major uplift to this portfolio, ensuring that Dr. Reddy’s is well-positioned in next-gen oncology care.

Conclusion

This collaboration between Alvotech and Dr. Reddy’s marks a significant development in the global biosimilar market, especially in the immuno-oncology segment. By targeting Keytruda®, a blockbuster cancer drug, the two companies aim to deliver a high-impact, affordable treatment option that could potentially benefit millions of patients worldwide.

This is more than just a business agreement—it is a strategic alliance that blends scientific expertise, manufacturing strength, and commercial reach, and reinforces the role of biosimilars in transforming cancer care accessibility.

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