Lupin Wins CDSCO Approval for a Nivolumab Biosimilar, Joining India's Race to Cut the Cost of Immunotherapy
CDSCO has approved Lupin's biosimilar of Bristol Myers Squibb's Opdivo (nivolumab), backed by a local Phase III trial and made with Hyderabad's Virchow Biotech. It joins Zydus and others in a market where biosimilars sell for about a quarter of the originator's price.
Lupin has received approval from India's drug regulator, the Central Drugs Standard Control Organisation (CDSCO), to manufacture and market a biosimilar of nivolumab, the PD-1 checkpoint inhibitor sold by Bristol Myers Squibb as Opdivo. The Economic Times first reported the approval on October 18, 2026, and Medical Dialogues and the biosimilars-focused law firm Pearce IP reported it independently.
Lupin becomes the latest Indian company to bring a copy of one of the world's best-selling cancer immunotherapies to the Indian market.
What was approved
According to the reports:
- The approval covers the same indications as the reference medicine.
- It is based on a local Phase III clinical trial run by Lupin that compared the biosimilar's pharmacokinetics, efficacy and immunogenicity with Opdivo.
- It is conditional on Lupin carrying out a Phase IV (post-marketing) study in India.
- Lupin has clearance for both the bulk drug substance and the finished formulation.
- The product will be manufactured with Virchow Biotech, a contract development and manufacturing organisation based in Hyderabad.
Lupin has not announced launch plans or pricing yet.
Why nivolumab matters
Nivolumab is a monoclonal antibody that blocks PD-1, a "brake" receptor on T-cells that tumours exploit to escape the immune system. Blocking it lets the immune system attack the cancer. The drug is used across a range of cancers, including lung cancer, melanoma, kidney cancer, and head and neck cancers.
The problem in India has been price. Originator checkpoint inhibitors cost tens of thousands of rupees per vial, and treatment runs for months, so most patients who could benefit have gone without. Biosimilars, which are highly similar copies of biologic drugs approved after comparative testing, are the main way to bring that cost down.
A crowded, contested market
Lupin is not first. Zydus Lifesciences launched India's first nivolumab biosimilar in January 2026, branded Tishtha, at ₹13,950 for a 40 mg vial and ₹28,950 for 100 mg. Zydus said in a regulatory filing that this was about one-fourth of the reference drug's price.
That launch followed a patent fight. On January 12, 2026, a division bench of the Delhi High Court set aside a July 2025 order that had stopped Zydus from selling its biosimilar over BMS's patent. The court allowed sales but directed Zydus to keep detailed sales accounts so that compensation could be calculated if BMS ultimately won its patent case.
Others are close behind. In October 2025, a CDSCO expert committee approved a Phase I/III trial for Reliance Life Sciences' nivolumab biosimilar, and Dr Reddy's reportedly launched its own version, branded Nivorz, in September, according to one report. More competitors should push prices down further.
Why it matters for India
Biologics are where India's pharmaceutical industry is trying to move up the value chain. Making a monoclonal antibody that matches an originator, and proving it in a Phase III trial, is far harder than copying a small-molecule pill. Lupin's approval, and its decision to work with a domestic CDMO, shows that the know-how and capacity are spreading beyond a few early movers.
For patients, the more important point is competition. With several Indian makers of nivolumab, prices should fall and checkpoint immunotherapy should reach far more people in India and in other price-sensitive markets.
What to watch
- Launch and price: Lupin has not said when its biosimilar will reach hospitals or how it will be priced against Zydus's Tishtha and other rivals.
- The Phase IV study: the post-marketing study required by CDSCO will add real-world safety and efficacy data from Indian patients.
- Export plans: an Indian Phase III trial and in-country bulk manufacturing could support filings in other price-sensitive markets, although Lupin has not announced any.
Sources
- Medical Dialogues — https://medicaldialogues.in/news/industry/pharma/cdsco-clears-lupin-to-manufacture-market-nivolumab-biosimilar-for-cancer-treatment-181639
- Pearce IP — https://www.pearceip.law/2026/10/18/lupins-biosimilar-to-bms-opdivo-nivolumab-approved-in-india/
- Business Standard (Zydus launch) — https://www.business-standard.com/companies/news/zydus-life-launches-nivolumab-biosimilar-in-india-after-delhi-hc-nod-126012201230_1.html
- Knowledge Ecology International (Delhi High Court ruling) — https://www.keionline.org/41152
- Pearce IP (Reliance Life Sciences trial) — https://www.pearceip.law/2025/10/14/indias-sec-approves-phase-i-iii-trial-for-reliance-life-sciences-biosimilar-nivolumab/