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 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.
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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
- Consultation with your treating neurologist. Confirmation of MS subtype, MRI review, prior DMT history, and clinical rationale for anti-CD20 therapy.
- Pre-treatment screening. Hepatitis B panel, immunoglobulins, vaccination review and update, baseline infection screen.
- Infusion facility identification. A licensed infusion centre is confirmed for the Day 1 and Day 15 loading and subsequent six-monthly maintenance cycles.
- 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.
- US-side sourcing. Reserve Meds coordinates with our US-licensed specialty wholesale partner to secure Briumvi from authorised distribution under DSCSA.
- Cold-chain shipment. Briumvi ships under validated 2-8 °C cold chain with continuous temperature logging and chain-of-custody documentation.
- 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
US list price (WAC) for Briumvi is approximately USD 59,000 per 450 mg infusion (list price; cash-pay rates vary by US specialty-pharmacy network from roughly USD 28,000 to 34,000 per infusion). Annual cost varies 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. WAC reference: FDA approval, TG Therapeutics product label, and GoodRx US WAC listing. Cash-pay range: US specialty-pharmacy 2025 cash-pay reporting (Drug Channels, AmerisourceBergen specialty network data). These figures are indicative drug-only reference pricing.
Indicative timing for the first infusion after cohort intake opens is 7-14 days from the moment a complete CDSCO application is submitted. Subsequent cycles are generally faster once the pathway is established.
If your clinical situation is time-sensitive, tell us at intake. 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.
What to monitor on Briumvi
Briumvi sits in the anti-CD20 class with Ocrevus (ocrelizumab) and Kesimpta (ofatumumab). Three safety signals stand out for an Indian patient and the treating neurology team beyond the hepatitis B screening already noted: progressive multifocal leukoencephalopathy (PML) and JC virus, persistent hypogammaglobulinaemia, and infusion reactions. Each is described below with the monitoring cadence and the prescribing-information citation.
Progressive multifocal leukoencephalopathy (PML) and JC virus. Anti-CD20 therapies including ublituximab carry a class risk for PML, a rare and serious brain infection caused by reactivation of the JC virus in immunosuppressed patients. Symptoms include progressive limb weakness, behavioural and cognitive changes, and disturbance of vision or speech. PML cases on ublituximab have been reported in the post-marketing setting (Briumvi Prescribing Information, section 5.4). Baseline JC virus antibody serology is not mandated by the FDA label before initiation, but most MS neurology programmes order it for risk stratification, particularly when sequencing onto Briumvi from natalizumab (Tysabri). Any new neurological symptom during treatment, including symptoms that do not fit the patient's prior MS relapse pattern, warrants urgent neurology re-evaluation with MRI. Reference: Briumvi (ublituximab-xiiy) Prescribing Information, TG Therapeutics, section 5.4, US FDA approval December 2022.
Hypogammaglobulinaemia and immunoglobulin monitoring. Anti-CD20 monoclonal antibodies deplete B-lymphocytes and, with repeated dosing, reduce circulating immunoglobulin levels over time. The Briumvi label requires baseline measurement of serum IgG, IgA, and IgM before treatment initiation, with monitoring during treatment and after discontinuation until B-cell repletion (Briumvi Prescribing Information, section 5.5). Indian MS-experienced centres typically check quantitative immunoglobulins at baseline and every six months at the maintenance-infusion visit. Persistent hypogammaglobulinaemia, in particular IgG below 4 g/L, increases the risk of serious bacterial infection; immunoglobulin replacement (IVIG) may be considered in consultation with immunology if levels remain low and infections recur. References: Briumvi Prescribing Information, section 5.5; Steinman L et al., Ublituximab versus teriflunomide in relapsing multiple sclerosis (ULTIMATE I and II), N Engl J Med 2022;387(8):704-714.
Infusion reactions and premedication. Infusion reactions are the most frequent adverse event in the ULTIMATE I and II trials, occurring in approximately 48 percent of Briumvi-treated patients and most often with the first (Day 1, 150 mg) infusion. Premedication is mandatory before each infusion: methylprednisolone 100 mg IV (or equivalent corticosteroid) approximately 30 minutes pre-infusion, plus an oral or IV antihistamine such as diphenhydramine 25 to 50 mg, plus an antipyretic such as paracetamol 650 mg orally (Briumvi Prescribing Information, section 5.1, dosing and administration). The first 150 mg infusion is delivered over approximately 4 hours with continuous observation; the 450 mg doses run over approximately 1 hour if the Day 1 infusion was tolerated. Reactions may present as throat tightness, flushing, headache, fever, urticaria, bronchospasm, or hypotension and are managed by slowing or temporarily stopping the infusion, optimising premedication, and observing recovery before resuming. Severe reactions, including anaphylaxis, require permanent discontinuation. References: Briumvi Prescribing Information, section 5.1 and dosing schedule; TG Therapeutics infusion administration guide.
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.
Recent regulatory and access news for Briumvi in India
The CDSCO Notifications feed at cdsco.gov.in/Notifications has not posted a Briumvi-specific notification over the last 12 months as of 2026-06-04. The Drugs Controller General of India has not added Briumvi to the Approved New Drugs list at cdsco.gov.in Approved-New-Drugs. The National Pharmaceutical Pricing Authority database at nppaindia.nic.in and the Pharmacovigilance Programme of India at ipc.gov.in have not registered Briumvi-specific signals. TG Therapeutics continues commercial rollout of ublituximab for relapsing multiple sclerosis; the regional MS societies continue to recognise anti-CD20 monoclonal antibodies as a first-line disease-modifying option. We update this section on each case file at intake; the snapshot date governs.
Next step
Examples and timings above are composite illustrations drawn from published sources; no individual patient is depicted. Reserve Meds is a US-based concierge coordinator; we are not the prescriber and not the dispensing pharmacy. Clinical decisions remain with your treating neurologist.