FDA Accepts COYA 302 Application as Dr. Reddy’s Expands Innovation Portfolio

Sponsored·By Wall Street Wire·September 18, 2025·3 min read·See disclaimer

Indian pharma giant expands innovation partnerships while contributing abatacept biosimilar to investigational combination therapy

Coya Therapeutics announced that the US Food and Drug Administration (FDA) has received its investigational new drug (IND) application for COYA 302, paving the way for a Phase II trial to treat amyotrophic lateral sclerosis (ALS). The milestone marks a strategic evolution for Dr. Reddy’s Laboratories, which has expanded beyond traditional generics by contributing a key biosimilar component to this novel therapeutic approach while continuing its established generics portfolio.

Understanding ALS and Unmet Medical Need

ALS, also known as Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects motor neurons in the brain and spinal cord. About 20,000 people live with ALS in the United States, with approximately 5,000 new cases diagnosed annually. The disease progressively weakens voluntary muscle control, with most patients experiencing respiratory failure within three to five years of symptom onset. Currently approved treatments provide limited benefit, creating significant unmet medical need for innovative therapeutic approaches.

Beyond Generic Competition

The partnership centers on COYA 302, a proprietary biologic combination therapy with a dual immunomodulatory mechanism intended to enhance regulatory T-cell function and suppress inflammation from activated monocytes and macrophages. The treatment combines proprietary low dose interleukin-2 and CTLA-4 Ig, with Dr. Reddy’s contributing the latter component through its abatacept biosimilar program.

This approach reveals how biosimilars can serve as platforms for innovation rather than merely cost-reduction tools. In early 2023, Coya entered into an in-licensing agreement with Dr. Reddy’s to license its proposed biosimilar abatacept for COYA 302 development, establishing the foundation for the broader collaboration.

While Dr. Reddy’s abatacept biosimilar is in advanced Phase III trials for traditional indications like rheumatoid arthritis, where the company believes it has First-to-Market status, the Coya collaboration represents an additional strategic direction. Rather than competing solely on price as a biosimilar alternative to Bristol Myers Squibb’s Orencia, Dr. Reddy’s is licensing its biosimilar candidate for integration into an entirely new therapeutic approach.

Milan Kalawadia, Chief Executive Officer, North America, at Dr. Reddy’s Laboratories Ltd. stated: “We are encouraged by the progress of COYA 302, particularly as Coya prepares to initiate this important clinical study. This milestone further reinforces the strong scientific and strategic rationale behind our partnership with Coya. We are energized by the potential of moving a step closer to offering a treatment for patients living with ALS, also known as Lou Gehrig’s disease.”

Strategic Partnership Structure

Under the agreement, Coya has granted Dr. Reddy’s exclusive commercialization rights for COYA 302 in the United States, Canada, the European Union and the United Kingdom. This geographical scope positions the collaboration in developed markets where innovation premiums typically justify higher pricing compared to traditional generics competition.

The IND receipt triggered a $4.2 million payment from Dr. Reddy’s Laboratories following the global agreement signed in December 2023. The financial structure reflects this innovation focus, with Dr. Reddy’s making a $7.5 million upfront payment to Coya, plus additional milestone payments totaling $8.4 million upon IND receipt and first patient dosing in the Phase II trial. The agreement includes development and regulatory milestones up to $40 million, plus sales-based milestone payments up to $677.25 million linked to cumulative net sales achievements. Dr. Reddy’s will also pay royalties ranging from low to middle teens on net sales.

Complementing Traditional Business Model

The collaboration demonstrates Dr. Reddy’s expansion into what the company describes in its 2024-25 annual report as “moving towards innovation through novel biologics” while maintaining its established generics and biosimilars portfolio. The company has collaborated with Coya Therapeutics for exclusive development and commercialisation of COYA 302, as noted in the same report.

This approach complements traditional biosimilar strategies focused on replicating existing therapies. Dr. Reddy’s is leveraging its biosimilar development capabilities as components in novel treatment approaches, potentially commanding innovation premiums while continuing to compete in generic markets with affordable alternatives.

The Phase II multi-centre, placebo-controlled, double-blind clinical study aims to assess COYA 302’s safety and efficacy in ALS patients, with Coya planning to initiate the study in Q4 2025. For Dr. Reddy’s, successful development could establish a template for future innovation partnerships that transform biosimilar platforms into differentiated therapeutic approaches targeting underserved patient populations alongside its traditional generics business.

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