Rituximab biosimilar — Indian WHO-GMP supply for R-CHOP, RA and ANCA vasculitis.
First-in-class anti-CD20 chimeric IgG1 monoclonal antibody — the B-cell-depleting biological that turned DLBCL into an immunochemotherapy-curable disease. 100mg and 500mg IV vials from Indian WHO-GMP biosimilar facilities, with EMA and MHRA biosimilar comparability dossier on file, 2-8°C cold-chain validated end-to-end, and TLS / infusion-reaction / HBV reactivation prevention protocol documented.
Multiple WHO-GMP biosimilar partner lines · 100mg and 500mg IV vials · CTD biosimilar comparability dossier on file · 2-8°C cold-chain validated.
Active ingredient
Rituximab, a chimeric (murine variable region, human IgG1 constant region) anti-CD20 monoclonal antibody. Mechanism: binds CD20 on the surface of normal and malignant B cells, depleting them via three pathways — CDC (complement-dependent cytotoxicity), ADCC (antibody-dependent cellular cytotoxicity via FcγRIII on NK cells / macrophages), and direct apoptosis induction. CD20 is absent from haematopoietic stem cells and plasma cells, so B-cell repopulation occurs from progenitors after therapy ends — typically 6-12 months.
Strengths stocked
100mg/10ml and 500mg/50ml at 10 mg/ml concentrate. Diluted in 0.9% NaCl or 5% glucose to 1-4 mg/ml for IV infusion. The 500mg vial is the high-volume tender line for adult R-CHOP, R-CVP and R-bendamustine demand (375 mg/m² typical adult body-surface dose maps to ~600-700mg per infusion). Subcutaneous rituximab (separate ready-to-use formulation, fixed-dose 1400mg/11.7ml + 1600mg/13.4ml) is a separate listing.
Indications
Oncology: DLBCL, follicular, mantle-cell, marginal-zone lymphoma; CLL (FCR, BR); HCL relapsed; Burkitt (R-EPOCH, R-CODOX-M/IVAC). Autoimmune: rheumatoid arthritis (post-TNFi), ANCA-associated vasculitis (induction + maintenance), pemphigus vulgaris, off-label membranous nephropathy / lupus nephritis. Standard oncology dosing 375 mg/m² (RA fixed 1000mg × 2 doses 2 weeks apart). WHO EML core. We supply for all approved + standard off-label indications.
Storage
2-8°C, do not freeze, protect from light. Vials 36 months shelf life. Diluted infusion: 24 hours at 2-8°C, 8 hours at room temperature in 0.9% NaCl or 5% glucose. Once diluted, infusion must complete within 24 hours due to microbial growth concerns (no preservative).
Shelf life
36 months from manufacture; minimum 24 months at dispatch. Or we won't ship it.
Pack format
Single vial per carton. Type-I clear glass vial, halobutyl rubber stopper, aluminium seal with flip-off cap. Outer carton and leaflet in destination-regulator language. Tumour lysis syndrome (TLS) prevention protocol, infusion-reaction pre-medication guidance and HBV-reactivation pre-screening warning prominently set on the SmPC. Biosimilar batch-traceability label per EMA / MHRA biosimilar pharmacovigilance requirement.
NHS biosimilar formulary, GCC NUPCO biosimilar tenders, African public-sector — across thirty markets, oncology + rheumatology.
India is our origin. We do not sell into the Indian market. Rituximab biosimilar is exported only.
United Kingdom
NHS England biosimilar switch policy mandates biosimilar rituximab as first-line for new R-CHOP, R-CVP and rheumatology rituximab patients since 2018. Rituximab is also the standard of care for ANCA-associated vasculitis (NICE TA308) and rheumatoid arthritis (NICE TA195) — biosimilar is the dispensing default. M Care biosimilar lines are MHRA-licensed-supplier-aligned. Where the primary biosimilar contract holder cannot fill demand, the MHRA Specials / named-patient import route covers the gap — see MHRA Specials.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH biosimilar tender awards (NUPCO biosimilar oncology + rheumatology tenders are a major channel — Saudi MoH biosimilar substitution policy since 2019; MoHAP, DHA and DOH Abu Dhabi for UAE — Cleveland Clinic Abu Dhabi haematology programme is a key buyer; Kuwait MoH Central Drug Store; MoPH Qatar including Hamad Medical Corporation; MoH Oman; NHRA Bahrain). SFDA, MoHAP and GCC central registration support the biosimilar comparability dossier filing.
Nigeria, Kenya, Ghana, South Africa, Ethiopia
Public-sector oncology + rheumatology biosimilar tenders (NAFDAC-registered for Nigeria — University College Hospital Ibadan haematology programme is a key buyer; KEMSA + MEDS for Kenya; FDA Ghana + Central Medical Stores; SAHPRA-registered for South Africa — Netcare and Mediclinic haematology centres; EFDA + EPSS for Ethiopia). Biosimilar pricing is 50-70% below originator — the affordability driver opens R-CHOP access to populations otherwise priced out of immunochemotherapy. Global Fund biosimilar-pathway tenders supported.
Germany, France, Brazil, Mexico
Supply via licensed importers under §72 AMG (Germany, with QP biosimilar certification on EU arrival), ANSM equivalent (France), ANVISA biosimilar (Brazil), COFEPRIS (Mexico). EMA biosimilar comparability dossier prepared per EMA/CHMP/BMWP guidelines with full Module 3 + extrapolation justification across oncology and autoimmune indications. Named-patient (Einzelimport) route available for the German channel.
TLS prophylaxis, slow first infusion, HBV pre-screening, and remember it depletes B cells for 6-12 months — rituximab is high-yield but high-vigilance.
Adult oncology dosing is 375 mg/m² IV every 3 weeks (with chemotherapy) or weekly × 4-8 doses (single-agent or maintenance). RA: fixed 1000mg × 2 doses, 2 weeks apart; repeat course at 6-12 months based on disease activity. ANCA vasculitis induction: 375 mg/m² weekly × 4 doses. First-infusion is the high-risk window for infusion reactions and TLS: start at 50 mg/h, increase by 50 mg/h every 30 min to maximum 400 mg/h. Pre-medicate with paracetamol 1g + diphenhydramine 25-50mg (chlorphenamine in UK practice) + IV fluids; methylprednisolone 100mg IV is added in CLL / high-disease-burden lymphoma. Tumour lysis syndrome is a real risk in high-WBC CLL and high-burden lymphoma — pre-treatment allopurinol (or rasburicase for high-risk), aggressive hydration and electrolyte monitoring (potassium, phosphate, urate, calcium, creatinine) for the first 48-72 hours. HBV reactivation is potentially fatal: pre-treatment screening for HBsAg, anti-HBc, HBV DNA is mandatory; HBsAg-positive patients need entecavir / tenofovir prophylaxis throughout therapy and 12-18 months after; anti-HBc-positive HBsAg-negative patients need monthly HBV DNA monitoring. Progressive multifocal leukoencephalopathy (PML) due to JC virus reactivation is rare but documented — any new neurological symptoms warrant urgent imaging and JC-virus PCR. B-cell depletion lasts 6-12 months post-therapy: live vaccines are contraindicated; killed vaccines have reduced response. Hypogammaglobulinaemia develops in ~5% of repeated-course patients and may need IVIg replacement. Diluent: 0.9% NaCl or 5% glucose; do not co-infuse with other drugs; do not push as IV bolus.
The documentation pack a regulator actually asks for — biosimilar comparability + extrapolation across oncology and autoimmune.
Rituximab biosimilar is a complex chimeric mAb — the regulatory pack is more demanding than a small-molecule generic, with extrapolation across oncology and autoimmune indications. Our role is manufacturer-facing — we sit between the Indian WHO-GMP biosimilar facility and your clinical, regulatory or procurement team.
CTD Module 3 + biosimilar comparability
Full chemistry, manufacturing and controls section per ICH Q5A-Q5E and EMA biosimilar guidelines (CHMP/437/04, CHMP/BMWP/403543/2010 for monoclonal antibodies). Biosimilar comparability covers physico-chemical characterisation (size, charge, glycosylation, post-translational modifications including the chimeric murine-Fab region), in-vitro functional assays (CD20 binding affinity, CDC, ADCC, apoptosis induction), clinical pharmacology bridging study + indication-extrapolation justification across follicular lymphoma → DLBCL → CLL → RA → ANCA vasculitis.
CoA and MoA, per batch
ELISA quantitation; identity by peptide mapping LC-MS/MS, IEF, CE-SDS; size variants by SEC-HPLC, AUC; charge variants by IEC-HPLC; glycan profile by HILIC-FLR (afucosylated glycoform critical for ADCC); potency by CD20-binding ELISA + CDC + ADCC reporter bioassays; aggregates by AUC + DLS; bioburden, sterility, bacterial endotoxin, host-cell protein (CHO HCP), residual host-cell DNA — signed by the manufacturer's authorised QC head.
CoPP, WHO-GMP, MFG licence
Issued by CDSCO (Central Drugs Standard Control Organization, India) and apostilled where the destination requires it. Biosimilar facility licence and EMA / MHRA biosimilar inspection certificates (where applicable) included. Notarised copies in the shipping pack.
Pack insert, labels, artwork
Destination-language PIL, labelling to local regulator standards. Biosimilar batch-traceability label per EMA / MHRA biosimilar pharmacovigilance requirement. TLS prevention protocol, HBV pre-screening warning, infusion-reaction pre-medication schedule, PML alert prominently set. Both oncology and autoimmune dosing schedules documented.
Temperature control
Pre-shipment validation on each shipper configuration. 2-8°C cold-chain mandatory throughout transit, no freezing. Active-cooled containers (Envirotainer, Cool Containers) for trans-continental shipments; passive PCM coolers with 96h temperature stability for shorter lanes. On-arrival cold-chain integrity check before pharmacy hand-over.
Pharmacovigilance
Local PV partner or a named PV contact organised in the destination market against registration. Periodic Safety Update Reports compiled to ICH E2C plus the biosimilar-specific traceability requirement (every adverse event references INN + manufacturer + lot number). Severe infusion reactions, TLS, HBV reactivation, PML, hypogammaglobulinaemia and serious infections in B-cell-depleted patients remain the PSUR priority signals.
R-CHOP, FCR and the rheumatology cross-supply.
Rituximab is the 'R' in R-CHOP, R-CVP, R-bendamustine, FCR; it's also used as a single-agent in RA and ANCA vasculitis. We carry the supporting cluster.
Cyclophosphamide
Alkylating agent, the 'C' in R-CHOP and FCR. 200mg / 500mg / 1g / 2g vials.
Doxorubicin
Anthracycline, the 'H' (hydroxydaunorubicin) in R-CHOP. 10mg / 50mg / 200mg + 20mg PEGylated.
Methotrexate
Antimetabolite, RA and IBD low-dose plus oncology high-dose. 50mg / 500mg / 1g + 2.5mg / 10mg tablets.
Bortezomib
Proteasome inhibitor, MM combos and post-rituximab MCL relapse. 2mg and 3.5mg lyophilised.
Trastuzumab
Anti-HER2 mAb biosimilar, HER2+ breast and gastric. 100mg / 150mg / 440mg vials.
All oncology →
120+ oncology SKUs: cytotoxics, targeted therapy, biosimilars, supportive care.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Strength (100mg or 500mg vial), vial count, destination, NHS biosimilar formulary / GCC NUPCO biosimilar tender / African public-sector oncology+rheumatology / NGO supply, target delivery. Flag if biosimilar comparability dossier or TLS / HBV pre-screening compliance set is needed for the receiving formulary committee.
- We route to the right line. Multiple WHO-GMP biosimilar rituximab lines on the M Care roster, including EMA-licensed biosimilar manufacturer facilities and MHRA-recognised biosimilar lines. Registered-market preference goes to facilities already holding the relevant destination biosimilar registration.
- Commercial and regulatory offer. FOB / CIF price (typically 50-70% below originator), lead time, biosimilar comparability dossier status per destination, TLS + HBV pre-screening compliance documentation, batch-traceability label compliance, cold-chain lane validation report. Inside one working day.
- Order, produce, release, ship. QC release on the Indian side. 2-8°C cold-chain dispatch, no freezing, active or passive cooled container per lane, in-transit temperature logging, on-arrival cold-chain integrity check. Photo evidence of seal integrity and thermal-log validation on request.
- After delivery. Batch records, CoA, MoA and cold-chain logs archived for the full shelf life. PV contact opened on registration with biosimilar-specific traceability per EMA / MHRA requirement; severe infusion reactions, TLS, HBV reactivation, PML and serious infections in B-cell-depleted patients remain the PSUR priority signals.
Rituximab biosimilar supply — the specific questions.
What strengths and formulations of rituximab do you supply?
IV concentrate: 100mg/10ml and 500mg/50ml at 10 mg/ml. Diluted in 0.9% NaCl or 5% glucose to 1-4 mg/ml for IV infusion. The 500mg vial is the high-volume tender line for adult R-CHOP, R-CVP, R-bendamustine and FCR demand. Subcutaneous rituximab (separate ready-to-use formulation, fixed-dose 1400mg/11.7ml for follicular / DLBCL or 1600mg/13.4ml for CLL, hyaluronidase co-formulated for SC absorption) is a separate listing in our biosimilar catalogue. Pack is one vial per carton in hospital pack.
Is your rituximab biosimilar approved by EMA / MHRA?
We supply biosimilar rituximab from manufacturers that hold EMA biosimilar approvals (CHMP positive opinions issued from 2017 onwards for first-wave biosimilars) and MHRA biosimilar approvals (post-Brexit alignment with EMA approvals continued via MHRA). Specific manufacturer EMA/MHRA approval status is shared against NDA per consignment — different M Care partner facilities hold different destination-market approvals, and we route the order to the line with the relevant approval for your destination. The EMA biosimilar approval covered full indication extrapolation from follicular lymphoma → DLBCL → CLL → RA → ANCA vasculitis, so a single biosimilar approval covers all approved indications for the originator.
What's included in your TLS and HBV-reactivation prevention compliance documentation?
Both are mandatory pre-treatment safety items per current EMA, MHRA, ASH and ESMO guidelines. Tumour lysis syndrome (TLS) prevention: pre-treatment risk stratification (high-WBC CLL, bulky lymphoma); allopurinol or rasburicase prophylaxis; aggressive hydration ≥3 L/m²/day; electrolyte monitoring schedule (potassium, phosphate, urate, calcium, creatinine at 0, 6, 12, 24, 48, 72 hours from first dose); first-infusion rate titration (50 mg/h start, 50 mg/h step-up every 30 min to max 400 mg/h). HBV reactivation prevention: HBsAg + anti-HBc + HBV DNA pre-screening before first dose; HBsAg-positive patients receive entecavir or tenofovir prophylaxis throughout therapy and 12-18 months after; anti-HBc-positive HBsAg-negative patients need monthly HBV DNA monitoring. Our destination-language SmPC carries both protocols; the pre-dispatch pack includes a hospital-pharmacy-committee-ready compliance set.
Which markets can you ship rituximab biosimilar into?
The UK (NHS biosimilar formulary supply, MHRA-aligned biosimilar lines for oncology + rheumatology), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers — biosimilar tender channel is the primary route — sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia) for public-sector oncology + rheumatology tenders with WHO PQ pathway support where applicable, Egypt, Jordan on the Levant side, Germany under §72 AMG with QP biosimilar certification, France under ANSM biosimilar pathway, Brazil (ANVISA biosimilar) and Mexico (COFEPRIS). We do not supply into India. Full market coverage is at markets.
What documentation is included with a rituximab biosimilar consignment?
Every consignment ships with a batch-specific Certificate of Analysis (ELISA quantitation, peptide mapping LC-MS/MS, IEF, CE-SDS, SEC-HPLC, IEC-HPLC, glycan profile by HILIC-FLR with afucosylated glycoform monitoring for ADCC potency, CD20-binding ELISA, CDC + ADCC reporter bioassays, aggregates by AUC + DLS, host-cell protein, residual host-cell DNA, sterility, bacterial endotoxin), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, biosimilar manufacturing licence, EMA / MHRA biosimilar inspection certificate (where applicable), Certificate of Origin (chamber-attested), destination-language pack insert with biosimilar batch-traceability label, TLS + HBV pre-screening protocol, infusion-reaction pre-medication schedule and PML alert, plus cold-chain temperature logs from pre-dispatch through on-arrival. Biosimilar-specific PV contact nominated in the destination market on registration.
Do you provide CTD biosimilar comparability dossiers for rituximab registration?
Yes. Full CTD Module 3 plus biosimilar comparability annex per EMA CHMP/437/04 and CHMP/BMWP/403543/2010 is available against a non-disclosure agreement, for registration with MHRA, GCC central registration, SFDA, MoHAP, NAFDAC, PPB, SAHPRA, EFDA, BfArM, ANSM, ANVISA, COFEPRIS and comparable bodies. The comparability exercise covers physico-chemical characterisation, in-vitro functional assays (CD20-binding, CDC, ADCC, apoptosis induction), clinical pharmacology bridging study, and the indication-extrapolation justification across haematological malignancies and autoimmune indications. Lead time on a biosimilar dossier against a new registration is typically 8-12 weeks from NDA signature given the complexity. See dossier preparation.
What are typical lead times for rituximab biosimilar orders, and what's the cold-chain requirement?
For registered markets with stock on hand, dispatch is typically 5-10 working days from confirmed order. For tender awards (NUPCO, NHS biosimilar framework, KEMSA, SAHPRA), the lead time is set in the tender award document. Biosimilar mAbs have longer made-to-order lead times (12-16 weeks for a full batch including QC release) given the upstream cell-culture and downstream purification timeline. 2-8°C cold-chain is mandatory throughout transit, no freezing. Active-cooled containers (Envirotainer, Cool Containers) for trans-continental shipments; passive PCM coolers with 96h temperature stability for shorter lanes. Cold-chain integrity check on arrival is the gating quality step before pharmacy hand-over.
Send the specifics. You'll have a price inside one working day.
Strength, vial volume, destination, NHS biosimilar formulary / GCC NUPCO tender / African public-sector oncology+rheumatology / Global Fund / NGO, target delivery, biosimilar comparability dossier requirement. That's the enquiry. Everything else is on us.