Zydus Lifesciences has secured a major regulatory breakthrough with the U.S. Food and Drug Administration's approval of Zycubo® for the treatment of Menkes disease. This milestone marks a significant achievement in rare disease therapeutics, establishing Zycubo® as the first approved therapy in the United States specifically indicated for this condition.

Regulatory Milestone Details

The FDA approval represents a critical development in addressing the unmet medical needs of patients with Menkes disease. Clinical studies have demonstrated that Zycubo® provides significant survival improvement for patients, establishing its therapeutic value in treating this rare genetic disorder.

Therapeutic Significance

The approval of Zycubo® addresses a significant gap in treatment options for Menkes disease patients in the United States. As the first approved therapy for this indication, the drug represents a breakthrough for families and healthcare providers managing this rare genetic condition. The demonstrated survival improvement in clinical studies underscores the therapeutic potential of this treatment option.

Company Impact

This FDA approval strengthens Zydus Lifesciences' position in the rare disease therapeutics market. The regulatory success of Zycubo® demonstrates the company's capability in developing treatments for conditions with significant unmet medical needs, potentially opening new avenues for growth in specialized therapeutic areas.

The Delhi High Court has delivered a significant ruling in favor of Zydus Lifesciences, allowing the pharmaceutical company to sell and market its biosimilar version of the life-saving anti-cancer drug nivolumab in India. A division bench comprising justices C. Hari Shankar and Om Prakash Shukla modified an earlier injunction, citing public interest and the imminent expiry of the patent held by innovator E.R. Squibb & Sons LLC.

Court's Decision and Rationale

The division bench overturned a July 2025 single-judge order that had restrained Zydus from launching its biosimilar following a plea by E.R. Squibb & Sons LLC, which markets the original drug under the brand Opdivo. The court noted that Squibb's patent is scheduled to expire on May 2, 2026, and emphasized that nivolumab is a crucial life-saving cancer medication.

"We are therefore unable to satisfy ourselves that, on this material, the learned single judge was justified in entirely injuncting the appellant from releasing its product in the market," the court observed during its verbal pronouncement. The bench determined that the balance of convenience favored permitting the biosimilar's sale for the remaining patent term while protecting the patentee's interests.

Safeguards and Compliance Requirements

To ensure fair compensation for the patent holder, the court has implemented specific safeguards:

The Patent Dispute Background

The legal battle began when US-based E.R. Squibb & Sons LLC approached the Delhi High Court in 2024, alleging that Zydus Lifesciences was preparing to launch its biosimilar version before the May 2026 patent expiry. Squibb holds an Indian patent covering the monoclonal antibody nivolumab and claimed that the Ahmedabad-based company had developed a biosimilar called ZRC-3276, applied for regulatory approvals, and conducted clinical trials.

The dispute escalated after Squibb issued a cease-and-desist notice to Zydus in May 2022. Zydus responded that it was conducting research and clinical trials protected under the "Bolar exemption" of the Patents Act, which allows generic drugmakers to use patented drugs for research and development to prepare for regulatory filings.

Market Significance and Pricing

Nivolumab is a monoclonal antibody immunotherapy used to treat several cancers, including lung, head and neck cancers, particularly when chemotherapy fails or proves less effective. The drug's importance is underscored by India's rising cancer incidence rates.

While these immunotherapy treatments are extremely valuable for hard-to-treat cancers, affordability remains a significant concern for patients. The availability of biosimilar versions could potentially improve access to these life-saving medications.

The court's decision represents a careful balance between protecting patent rights and ensuring public access to essential cancer treatments. With a detailed written judgment still awaited, this ruling could have broader implications for the pharmaceutical industry's approach to biosimilar launches and patent disputes in India.