This Week in Biosimilars: Oncology Takes the Lead in India

India’s oncology biosimilars space surges this week as manufacturers accelerate access to critical cancer therapies.

Biosimilar competition intensifies around nivolumab, the PD-1 checkpoint inhibitor that anchors immuno-oncology treatment.

Indian firms race to expand patient reach while global patent disputes slow the same molecule elsewhere.

This week’s developments highlight two distinct speeds of biosimilar progress: rapid market entry and price pressure in India versus prolonged courtroom delays in the United States.

Oncology biosimilars now command attention as companies convert manufacturing strength into broader treatment options across multiple cancer types.

India’s Nivolumab Race Heats Up

Dr. Reddy’s Laboratories enters India’s nivolumab market with the commercial launch of Nivorz, its biosimilar to Bristol Myers Squibb’s Opdivo. The Hyderabad-based company manufactures the product at its Bachupally biologics facility and offers it in 40 mg, 100 mg and 240 mg single-dose vials for intravenous infusion.

The Drugs Controller General of India approved Nivorz after a multi-country clinical trial that enrolled 288 patients, including 252 from India and 36 from Russia. The study confirmed comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference product.

This launch ends Zydus Lifesciences’ position as the sole biosimilar supplier. Zydus introduced Tishtha earlier this year following a legal contest with the innovator. Tishtha reaches patients in 100 mg and 40 mg strengths at Rs 28,950 and Rs 13,950, respectively. The company positions these prices at roughly one-fourth of the innovator’s cost.

Dr. Reddy’s does not disclose its own pricing for Nivorz, yet the dual presence of two Indian manufacturers sets the stage for sharper competition.

Key features of the Indian launch include:

• Coverage of 12 cancer indications spanning metastatic non-small cell lung cancer, renal cell carcinoma, melanoma, classical Hodgkin lymphoma, urothelial carcinoma, colorectal cancer, oesophageal cancer, gastric cancer, hepatocellular carcinoma and malignant pleural mesothelioma.
• Application across early-stage, locally advanced, recurrent and metastatic disease in both solid tumours and haematological malignancies.
• Positioning within an immuno-oncology market valued at approximately Rs 3,900 crore, where nivolumab, pembrolizumab and toripalimab currently dominate.

Company leaders emphasise access. M.V. Ramana, CEO of Global Generics at Dr. Reddy’s, notes that the launch strengthens the oncology portfolio and expands presence in immuno-oncology at a time when many patients still struggle to obtain immunotherapy. Sridevi Khambhampaty, global head of biologics, describes the move as a milestone that widens patient access to complex biologic therapies.

Also Read: How Biologics and Complex Therapies Are Reshaping CDMO Strategy

US Courts Slow the Same Molecule

Bristol Myers Squibb and Ono Pharmaceutical file suit against Amgen in Delaware federal court to block the proposed Opdivo biosimilar. The complaint alleges infringement of seven U.S. patents. Opdivo generated more than USD 5.9 billion in U.S. revenue last year and more than USD 10 billion globally in 2025 across more than 65 countries.

BMS projects patent exclusivity through 2028. Amgen has submitted its FDA application and remains confident it will join the first wave of Opdivo biosimilars. Typical patent litigation in the District of Delaware runs 18 to 30 months before trial or resolution, creating a multi-year delay that keeps competitive pricing out of reach for American patients.

Capacity Investments Cement India’s Edge

India continues to reinforce the infrastructure that sustains this access advantage. Amneal Pharmaceuticals plans to invest up to USD 200 million (around Rs 1,680 crore) over the next four to five years to construct two new greenfield facilities in Ahmedabad.

The sterile capacity directly supports biosimilar production, including oncology products that reference Neupogen, Neulasta and Avastin. Amneal’s recent acquisition of Kashiv BioSciences further strengthens its biosimilar capabilities and positions the company to scale complex biologics for both domestic and global markets.

These moves illustrate a clear divergence. Indian manufacturers launch competing nivolumab biosimilars, drive prices downward and expand treatment options across a dozen cancer indications.

American patients remain locked behind patent litigation that can stretch for years. Meanwhile, fresh capital flows into Indian sterile and biosimilar capacity, ensuring the manufacturing base keeps pace with demand. Oncology biosimilars therefore advance at two speeds this week, one measured in months of market competition, the other in years of courtroom procedure.

Key Takeaway

• Dr. Reddy’s launches Nivorz and ends Zydus Lifesciences’ sole hold on India’s nivolumab biosimilar market, intensifying competition that expands patient options across 12 cancer indications.
• Zydus already offers Tishtha at prices near one-fourth of the innovator cost, creating immediate pressure that benefits India’s Rs 3,900 crore immuno-oncology segment.
• Bristol Myers Squibb and Ono sue Amgen over seven U.S. patents on Opdivo, a move that can delay biosimilar entry for 18 to 30 months while BMS claims exclusivity until 2028.
• Amneal commits up to USD 200 million for new Ahmedabad facilities focused on peptide synthesis and sterile fill-finish capacity, directly supporting oncology biosimilar growth.
• India’s manufacturing investments and dual biosimilar launches deliver faster access, while U.S. patent courts keep the same drug class locked in prolonged legal fights.