Eculizumab biosimilar — Indian WHO-GMP supply for PNH, aHUS, gMG and NMOSD specialist centres.

300mg/30mL concentrate for solution for infusion, single-vial. This is the Soliris standard and the only commercial presentation worldwide — eculizumab has never been multi-strength. Dilute to 5 mg/mL in 0.9% sodium chloride for IV infusion over 35 minutes minimum, no in-line filter required. Adult induction is 600 mg weekly x 4 (two vials per dose), then 900 mg week 5, then 900 mg every 2 weeks maintenance (three vials per dose). Paediatric weight-banded dosing per SmPC.

No — eculizumab is on neither. The originator's pre-biosimilar pricing (approximately £340,000 per patient annually) kept it off the WHO EML core list, and orphan biologics like eculizumab fall outside the WHO Prequalification programme scope. Biosimilar candidates are assessed through SRA-reliance pathways — MHRA, EMA, ANVISA, COFEPRIS — with EMA-style biosimilar comparability principles. The economic argument for biosimilar entry on this molecule is structural: even modest price reductions translate to significant orphan-drug-budget headroom for specialist centres. Biosimilar economics may shift the EML calculus in future revisions, but as of today, eculizumab is outside both WHO frameworks.

Meningococcal vaccination is mandatory before the first eculizumab dose — quadrivalent ACWY conjugate plus monovalent serogroup B, completed at least 2 weeks before initiation. Revaccination per local public-health guidance (typically every 2-3 years for ACWY, single course for MenB). If the vaccine course cannot be completed in advance, antibiotic prophylaxis with penicillin V (or ciprofloxacin if penicillin-allergic) is mandatory until the course is finished and 2 weeks have elapsed. A patient meningococcal alert card is issued at first dose and carried for the duration of therapy plus 3 months post-discontinuation — fever, headache, neck stiffness, photophobia, or petechial rash on a patient on eculizumab is meningococcal sepsis until proven otherwise. Our pack inserts and SmPCs carry the boxed-warning analogue per current MHRA, EMA and FDA originator labelling. The risk-management programme documentation, vaccination checklist and patient alert-card stock are provided to the receiving hospital pharmacy at first consignment.

The UK (NHS Highly Specialised Services commissioning route or named-patient / MHRA Specials route during shortage, with MHRA EAMS available for early access), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers — orphan-drug and rare-disease budget tenders are the channel — sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa) for specialist tertiary-centre and compassionate-use supply with biosimilar comparability dossier support. Germany under §72 AMG, France under ANSM-equivalent route, Brazil (ANVISA RDC 55/2010 biosimilar pathway), Mexico (COFEPRIS), Philippines (FDA Philippines). We do not supply into India. M Care does not hold FDA (United States) or TGA (Australia) registrations — those markets are out of scope. Full market coverage is at markets.

Every consignment ships with a batch-specific Certificate of Analysis (cell-based haemolysis inhibition potency, peptide map identity, SE-HPLC monomer purity, IEX charge-variant profile, glycan profile by HILIC-UPLC, host-cell protein, host-cell DNA, residual protein A, sterility, bacterial endotoxin), Method of Analysis, biosimilar comparability summary against the reference originator, Certificate of Pharmaceutical Product (CoPP), biologics-specific WHO-GMP certificate, manufacturing licence, Certificate of Origin (chamber-attested), destination-language pack insert with meningococcal-infection boxed warning, patient meningococcal alert cards, pre-treatment vaccination checklist, EMA-aligned risk-management programme documentation, plus continuous 2-8°C temperature logs from manufacturer release through customs to specialist-centre pharmacy. PV contact nominated on registration; meningococcal infection events under expedited safety reporting.

Yes. Full CTD Module 3 dossiers supplemented by an EMA-aligned biosimilar comparability dossier are available against a non-disclosure agreement, for registration with MHRA, EMA-aligned national authorities (BfArM, ANSM), GCC central registration, SFDA, MoHAP, NAFDAC, SAHPRA, ANVISA (RDC 55/2010 biosimilar pathway) and COFEPRIS. Module 2 summaries and Module 1 administrative sections are prepared in destination-specific format. Biosimilar comparability evidence covers analytical similarity (peptide mapping, glycan profiling, charge-variant analysis, SE-HPLC, post-translational modification fingerprint), functional similarity (C5 binding affinity by SPR, cell-based haemolysis inhibition), and clinical comparability where the receiving authority requires it. Lead time on a biosimilar dossier against a new registration is typically 8-14 weeks from NDA signature, longer than small-molecule generics. See dossier preparation and orphan-drug supply.

For registered markets with stock on hand, dispatch is typically 7-14 working days from confirmed order — longer than small-molecule generics because biologics QC release (cell-based potency, glycan profile, host-cell protein) takes more bench time. For specialist-centre named-patient or compassionate-use supply with urgency flagged (PNH crisis, aHUS thrombotic microangiopathy presentation, gMG myasthenic crisis), cold-chain air-freight out of Mumbai can be on a flight within 96 hours. Made-to-order biologics batches run 14-22 weeks inclusive of fermentation, purification, fill-finish, biologics-specific QC release and destination artwork. Eculizumab requires uninterrupted 2-8°C cold-chain: pre-conditioned PCM shippers, continuous BLE temperature logging from manufacturer release through customs to specialist-centre pharmacy, excursion thresholds (-1°C and +9°C) flagged automatically. Do not freeze. Do not shake. Protect from light. On-arrival inspection protocol agreed with receiving hospital pharmacy in advance — visual inspection for vial integrity, particulate matter, discolouration; refusal at arrival if logger excursion flagged or seal compromised.