Tishtha Nivolumab 100mg Injection

Tishtha 100mg Injection (Nivolumab) – World’s First Nivolumab Biosimilar by Zydus Lifesciences | Generic Opdivo

Reviewed by a qualified oncologist | Last updated: April 2026 Prescription-only | Administered by oncologist in clinical setting only | Biomarker testing recommended before use

What It Is

Tishtha 100mg Injection contains Nivolumab 100mg — a PD-1 (programmed death-1) immune checkpoint inhibitor and the active molecule in branded Opdivo® (Bristol Myers Squibb). Manufactured by Zydus Lifesciences Ltd (Ahmedabad, India), Tishtha is the world’s first biosimilar of Nivolumab, launched in India on January 22, 2026 — at approximately one-fourth the cost of Opdivo.

Available in two strengths: 40mg (₹13,950) and 100mg (₹28,950). The dual-strength portfolio allows oncologists to optimise weight-based dosing and reduce vial wastage — a significant advantage in real-world immunotherapy practice.

Zydus’s biosimilar programme in oncology already includes Vivitra (trastuzumab), Ujvira (T-DM1), Bryxta (bevacizumab), and Exemptia (adalimumab). Tishtha adds nivolumab as its flagship immuno-oncology entry.

How It Works

Cancer cells exploit the PD-1/PD-L1 immune checkpoint — a natural “off switch” on T cells — to hide from the immune system. PD-L1 expressed on tumour cells binds to PD-1 on T cells, sending a signal that prevents the T cell from attacking.

Nivolumab in Tishtha is a fully human IgG4 monoclonal antibody that binds to PD-1 on T cells, blocking PD-L1 and PD-L2 from engaging it. This releases the brake on T-cell activity — restoring the immune system’s ability to detect and destroy tumour cells. Unlike chemotherapy, which directly kills cells, nivolumab works by reactivating the patient’s own immune response against the cancer.

What It Treats

Tishtha carries all indications of reference nivolumab (Opdivo). NCCN 2025/2026 guidelines include Category 1 recommendations across:

2025/2026 key new indications:

• CheckMate 9DW: FDA approved April 2025 — nivolumab plus ipilimumab as first-line for unresectable HCC. Median OS 23.7 months vs 20.6 months with TKI.
• CheckMate 8HW: NCCN 2025 — nivolumab plus ipilimumab expanded to first-line MSI-H/dMMR metastatic colorectal cancer (Category 2A).
• CheckMate 77T: NCCN 2025 Category 1 — perioperative nivolumab for resectable stage II–IIIb NSCLC.

Why Tishtha — The Price Reality

Originator Opdivo (nivolumab 100mg) is priced at approximately $1720 –$2000 per vial in India. Tishtha 100mg is priced at $1070 — less than of Opdivo. For a typical NSCLC patient requiring nivolumab 360mg every 3 weeks, the annual treatment cost difference runs into millions of rupees. Globally, the Opdivo cost burden is even higher — pricing in the USA, UK, and UAE places nivolumab among the most expensive cancer medicines available.

Zydus estimates Tishtha could benefit over 5 lakh (500,000) patients in India alone by making immunotherapy economically accessible.

Dosage

All doses are weight-based or flat-dose per indication. Standard schedules used with reference nivolumab:

Administer as a 30-minute IV infusion through a 0.2–1.2 micron in-line filter. Do not administer as IV push or bolus. Pre-medication is not routinely required but may be given at physician discretion.

Store at 2–8°C. Do not freeze. Do not shake.

Important Warnings

Immune-mediated adverse reactions (imARs): Nivolumab can cause severe and fatal immune-mediated reactions in any organ system — including pneumonitis, colitis, hepatitis, endocrinopathies (thyroiditis, hypophysitis, adrenal insufficiency), nephritis, skin reactions, myocarditis, and neurological complications. Most are manageable with corticosteroid therapy and dose modification when detected early. Monitoring at every infusion visit is mandatory.

Corticosteroid management: Initiate systemic corticosteroids (prednisone 1–2 mg/kg/day or equivalent) for Grade 2 or higher immune-mediated reactions. Taper over at least 4 weeks after improvement. Permanently discontinue for Grade 4 or recurrent Grade 3 reactions.

Infusion reactions: Monitor patients during infusion. Interrupt for Grade 1–2 reactions. Permanently discontinue for Grade 3–4.

Embryo-foetal toxicity: Can cause foetal harm. Effective contraception required during and for 5 months after last dose.

Side Effects

Very common: Fatigue. Rash. Diarrhoea. Nausea. Pruritus. Decreased appetite. Musculoskeletal pain. Elevated liver enzymes (AST/ALT). Thyroid dysfunction.

Immune-mediated (require immediate oncologist contact): Shortness of breath or cough (pneumonitis). Severe diarrhoea or abdominal pain (colitis). Jaundice or dark urine (hepatitis). Unusual headache, visual changes, extreme fatigue (endocrinopathy). Chest pain or arrhythmia (myocarditis — rare but potentially fatal).

Monitoring: LFTs, TFTs, renal function, blood glucose, CBC — before each infusion and as clinically indicated.

FAQ

Is Tishtha the same as Opdivo? Tishtha contains the identical active molecule — nivolumab — as Opdivo. As a biosimilar, it has been developed to be highly similar with no clinically meaningful differences in efficacy, safety, or immunogenicity. It is the world’s first nivolumab biosimilar.

When was Tishtha launched? January 22, 2026 in India by Zydus Lifesciences — making it the first nivolumab biosimilar in the world.

What is the price difference vs Opdivo? Tishtha 100mg is priced at ₹28,950 — approximately one-fourth of originator Opdivo pricing in India. Internationally, the cost advantage is even greater given Opdivo’s pricing in the USA, UK, and UAE.

Does nivolumab require PD-L1 testing? PD-L1 testing is required for some indications (e.g., NSCLC monotherapy) but not all (e.g., MSI-H CRC, melanoma with ipilimumab). MSI/MMR testing is required for colorectal cancer. Your oncologist will confirm required biomarker testing for your specific cancer type.

Do you ship Tishtha internationally? Yes — discreet shipping to USA, UK, UAE, Canada, Thailand, Philippines, Saudi Arabia, Australia, and India.

References

1. Zydus Lifesciences — Tishtha Launch Announcement, January 22, 2026 https://www.zyduslife.com/investor/admin/uploads/21/83/Zydus-launches-the-world-s-first-biosimilar-of-Nivolumab—Tishtha—-in-India-to-treat-multiple-cancers.pdf
2. NCCN 2025 Guidelines Updates: CheckMate 77T (perioperative NSCLC Cat.1); CheckMate 8HW (MSI-H CRC Cat.2A) — ASCO Post (May 2025) https://ascopost.com/issues/may-25-2025/nccn-clinical-practice-guidelines-in-oncology-2025-updates/
3. CheckMate 9DW: Nivolumab + Ipilimumab vs TKI in First-Line HCC — FDA Approved April 2025 — Pharmacy Times https://www.pharmacytimes.com/view/updates-in-treatment-of-unresectable-hepatocellular-carcinoma
4. CheckMate 9LA — 6-Year OS Data for Nivolumab + Ipilimumab + Chemo in NSCLC — ESMO Open (May 2025) https://www.esmoopen.com/article/S2059-7029(25)00992-5/fulltext
5. FDA Approves Perioperative Nivolumab for Resectable NSCLC (CheckMate 77T) — OncLive https://www.onclive.com/view/fda-approves-perioperative-nivolumab-for-resectable-nsclc
6. Nivolumab (Opdivo) Prescribing Information — Bristol Myers Squibb / FDA (Updated 2024) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125554s128lbl.pdf