How to access Briumvi from India — the named-patient import pathway, 2026

By Reserve Meds · Clinical & regulatory team · Last reviewed 2026-04-24

An Indian patient with relapsing multiple sclerosis (MS) — including clinically isolated syndrome, relapsing-remitting, and active secondary-progressive disease — may receive a prescription for Briumvi (ublituximab) from their treating neurologist. Briumvi is FDA-approved, developed by TG Therapeutics, and is a recognised anti-CD20 monoclonal antibody option distinguished by a shorter infusion duration than earlier anti-CD20 therapies. In India, Briumvi is not routinely registered for domestic dispensing, and access is typically coordinated through the named-patient import pathway under the Central Drugs Standard Control Organisation (CDSCO) framework.

This guide explains the pathway, documentation your physician prepares, typical timing and cost bands, and where Reserve Meds fits in.

The clinical situation

Briumvi is a glycoengineered anti-CD20 monoclonal antibody that depletes B cells. It is administered as an intravenous infusion. The standard regimen is a 150 mg first infusion on Day 1, a 450 mg infusion on Day 15 (over approximately one hour once the initial tolerability is established), followed by 450 mg every 24 weeks (six months). The shorter infusion time relative to some other anti-CD20 therapies is a practical differentiator for patients and infusion centres.

Eligibility requires a confirmed relapsing MS diagnosis per McDonald criteria, MRI evidence, and a rationale for anti-CD20 therapy. Before first dose, your neurologist will screen for active or chronic hepatitis B (HBsAg and anti-HBc), update vaccinations (including live vaccines before depletion), assess baseline immunoglobulins, and screen for active infection. During therapy, IgG/IgM monitoring and infection surveillance continue at each cycle. Infusion reactions are most common with the first dose; premedication with corticosteroid and antihistamine is standard.

Is Briumvi legally importable into India?

Yes — through the CDSCO personal-import / named-patient framework administered under the Drugs and Cosmetics Rules. The mechanism permits import of an unregistered medicine for a specific named patient when (a) the medicine is approved by a recognised reference authority such as the US FDA, (b) no clinically equivalent registered alternative is suitable for the patient, (c) a qualified Indian physician accepts clinical responsibility, and (d) chain of custody is documented. India has a functioning named-patient pathway used across oncology, MS, and rare disease.

How the pathway works, step by step

1. Consultation with your treating neurologist. Confirmation of MS subtype, MRI review, prior DMT history, and clinical rationale for anti-CD20 therapy.
2. Pre-treatment screening. Hepatitis B panel, immunoglobulins, vaccination review and update, baseline infection screen.
3. Infusion facility identification. A licensed infusion centre is confirmed for the Day 1 and Day 15 loading and subsequent six-monthly maintenance cycles.
4. CDSCO named-patient application. Your physician or the hospital pharmacy files the application with clinical rationale, patient reference, product details, and chain-of-custody commitment.
5. US-side sourcing. Reserve Meds coordinates with our US-licensed specialty wholesale partner to secure Briumvi from authorised distribution under DSCSA.
6. Cold-chain shipment. Briumvi ships under validated 2–8 °C cold chain with continuous temperature logging and chain-of-custody documentation.
7. Arrival and administration. The infusion facility receives the vials and schedules infusions under your neurologist's care.

What documentation your physician needs

• Clinical rationale letter confirming relapsing MS subtype and Briumvi as the indicated therapy
• Verification of Indian medical registration (NMC / state council)
• MRI report supporting the diagnosis
• Hepatitis B screening results and vaccination history
• Baseline immunoglobulin levels
• Identification of the administering infusion facility
• Planned dosing calendar (150 mg Day 1, 450 mg Day 15, then 450 mg q24 weeks)

Reserve Meds provides a physician documentation kit bundling templates CDSCO reviewers expect for anti-CD20 MS named-patient imports.

Typical costs and indicative timing

Briumvi's US cash-pay reference cost for a maintenance dose sits in an indicative 2026 range of roughly USD 28,000–34,000 per infusion, with annual cost varying by loading versus maintenance year. Cold-chain international logistics, CDSCO documentation handling, and concierge coordination add incremental cost. Reserve Meds issues a full transparent quote at the start of intake. These figures are indicative drug-only reference pricing, not guaranteed.

Indicative timing — not guaranteed — for the first infusion after cohort intake opens is approximately 7–14 days from the moment a complete CDSCO application is submitted. Subsequent cycles are generally faster once the pathway is established.

Reserve Meds is in pre-launch. Fulfillment availability is limited to our first cohort, and all timelines published on this site are indicative. If your clinical situation is time-sensitive, flag that when you join the waitlist — we triage accordingly.

Reserve Meds's role

• Sourcing. Through our US-licensed specialty wholesale partner, operating under DSCSA chain-of-custody.
• Documentation. Regulatory package for your physician and CDSCO review.
• Logistics. Validated cold-chain shipment to your prescribing infusion facility.
• Concierge case lead. A named point of contact coordinating each six-month cycle.

What we do not do: we are not the prescriber, do not practise medicine, and are not the dispensing pharmacy. All clinical decisions remain with your treating neurologist and the administering infusion facility. We operate on a waitlist basis during pre-launch.

Frequently asked

Is this legal in India? Yes, when executed through the CDSCO named-patient / personal-import framework with appropriate documentation and a licensed administering facility. See our trust and compliance page.

Why the short infusion time? Briumvi's glycoengineering and dosing profile permit approximately one-hour maintenance infusions once initial tolerability is established, versus the multi-hour infusions typical of earlier anti-CD20 therapies. This is convenience, not clinical superiority; your neurologist selects therapy based on the full clinical picture.

How does Briumvi compare with Ocrevus or Kesimpta? All three are anti-CD20 therapies. Briumvi and Ocrevus are IV with six-monthly dosing; Kesimpta is a monthly self-administered subcutaneous injection. Briumvi's infusion time is shorter than Ocrevus. Your neurologist selects based on disease subtype, logistics, and patient preference.

Why hepatitis B screening? Anti-CD20 therapy can reactivate latent hepatitis B, so pre-treatment screening is mandatory under FDA labeling and standard MS practice.

Will private insurance cover this? Cash-pay is the default. Some Indian private insurers consider named-patient imports case by case; we supply documentation but do not process claims directly.

Next step — join the first-cohort waitlist

Reserve Meds is opening to a limited first cohort in 2026. Add your case to the waitlist and our concierge case lead will reach out when we enter intake for Briumvi coordination in India.

Add me to the Briumvi waitlist

Examples and timings above are composite illustrations drawn from published sources and typical named-patient patterns. Your individual case is assessed by your physician and our clinical-regulatory team; Reserve Meds does not guarantee outcomes or timelines.

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Reserve Meds is a US-based concierge coordinator for cross-border specialty medicine. We are in pre-launch; service availability is limited to our first cohort and published timelines are indicative, not guarantees. Cash-pay. Export-only (US → overseas). Composite case examples. Not medical advice.

Clinical & regulatory review: Reserve Meds clinical team and AI regulatory-counsel review pipeline. Last medically reviewed: 2026-04-24.