Particle.news
Download on the App Store
6 ARTICLES
·
5h ago

Delhi High Court Allows Zydus to Market Nivolumab Biosimilar on Public‑Interest Grounds

Citing public interest in access to a life‑saving therapy, the bench required Zydus to keep detailed sales accounts until the patent lapses on May 2, 2026.

Image
Image
Image
Image

Overview

  • A division bench of Justices C Hari Shankar and Om Prakash Shukla set aside a July 18, 2025 interim injunction that had restrained Zydus from selling its Nivolumab biosimilar.
  • The order permits manufacture and sale of ZRC 3276 while binding Zydus to maintain accounts of realizations from sales until expiry of the suit patent.
  • The court said it must err in favor of public access to life‑saving drugs and noted that innovator rights can be safeguarded through accounting and other measures.
  • According to Zydus as recorded in the order, treatment with its biosimilar would cost about 70% less than the patented product.
  • The bench flagged that the earlier ruling used product‑to‑product mapping rather than product‑to‑claim analysis, and noted the SEC of the CDSCO had recommended the product for approval in July 2024.