Filgrastim biosimilar — Indian WHO-GMP G-CSF supply for febrile neutropenia prophylaxis, severe chronic neutropenia and HSCT mobilisation.

300mcg/0.5mL and 480mcg/0.5mL pre-filled syringes with integrated needle-safety device on most partner lines — the high-volume oncology day-unit and home-administration formats. 300mcg/1mL and 480mcg/1.6mL vials for hospital-pharmacy multi-patient dosing and IV infusion preparation. Standard adult dose 5 mcg/kg/day subcutaneous, started 24-72 hours after the last cytotoxic dose, continued until ANC recovery above 1.5 x 10^9/L (typically 5-10 days). HSCT mobilisation 10 mcg/kg/day. Pegfilgrastim is the longer-acting sibling — same MOA, given as a single 6mg dose per chemotherapy cycle vs daily filgrastim — available on a separate partner line.

Multiple M Care partner facilities have filgrastim biosimilar lines under WHO Prequalification biotherapeutic pathway assessment for Global Fund chemo-supportive procurement. Biotherapeutic PQ assessment is a longer pathway than small-molecule PQ — comparability, functional bioassay and PK/PD similarity data must be reviewed before listing. We share the up-to-date assessment status against each partner line on enquiry. We engage on Global Fund chemo-supportive procurement scoping, country-level public-sector tenders (KEMSA, NAFDAC, CMS Ghana, EPSS, MSD Tanzania, NMS Uganda, SAHPRA), and NGO procurement (AORTIC, World Child Cancer, St Jude Global, MSF, Direct Relief, Partners In Health) through the same biosimilar manufacturing lines.

Filgrastim is a recombinant biological — 2-8°C cold chain is mandatory through the entire supply chain, manufacture to bedside. Every consignment ships in a qualified 2-8°C insulated shipper with phase-change material and a continuous in-transit data logger. Do not freeze — freezing causes protein aggregation, loss of bioactivity and immunogenicity risk; freeze-detected consignments are quarantined and not released to dispensing. Do not shake — mechanical stress drives the same aggregation pathway. On arrival the data logger is reviewed against the SmPC excursion limits (typically 72 hours below 25°C single excursion), mean kinetic temperature calculated, and product released to dispensing or quarantined as appropriate. Cold-chain validation summary is in the shipping documentation pack — see cold-chain validation.

The UK (NHS oncology pharmacy and HSCT-unit supply or named-patient / MHRA Specials route during shortage), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers — oncology supportive-care and HSCT-unit tenders are the main channels — sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia, Tanzania, Uganda, Rwanda) for tender and teaching-hospital supply with WHO PQ biotherapeutic assessment supported — Global Fund chemo-supportive procurement scoping is a developing channel. Egypt, Jordan, Iraq on the Levant side. Germany under §72 AMG, France under ANSM-equivalent route, Brazil (ANVISA), Mexico (COFEPRIS) and the Philippines (FDA Philippines). M Care does not hold FDA or TGA registrations, and we do not represent these markets. We do not supply into India. Full market coverage is at markets.

Every consignment ships with a batch-specific Certificate of Analysis (RP-HPLC and SEC-HPLC purity, peptide mapping, charge variants, host cell protein and DNA, bacterial endotoxin, bioidentity by cell-based proliferation bioassay, protein content, pH, osmolality, sub-visible particles), Method of Analysis, Certificate of Pharmaceutical Product (CoPP), WHO-GMP certificate, manufacturing licence, WHO Prequalification biotherapeutic assessment status documentation where applicable, EMA biosimilar comparability summary, Certificate of Origin (chamber-attested), destination-language pack insert with cold-chain handling instructions + bone-pain counselling note + splenic rupture warning + sickle cell haematology-consultation requirement, plus continuous 2-8°C temperature logs from pre-dispatch through on-arrival. PV contact nominated on registration.

Yes. Full EMA biosimilar pathway dossiers are available against a non-disclosure agreement, for registration with MHRA, GCC central registration, SFDA, MoHAP, NAFDAC, PPB, SAHPRA, EFDA, TMDA, NDA, BfArM, ANSM, ANVISA, COFEPRIS, FDA Philippines and comparable bodies that recognise the EMA biosimilar pathway. Biosimilar dossiers are heavier than small-molecule dossiers — comparability data (analytical similarity, functional bioassay, PK/PD similarity, immunogenicity) sits alongside conventional CMC, and lead time on a biosimilar dossier against a new registration is typically 6-10 weeks from NDA signature. WHO PQ biotherapeutic dossier prepared separately. M Care does not hold FDA or TGA registrations; the EMA biosimilar pathway and MHRA recognition are the primary regulatory anchors. See dossier preparation.

For registered markets with stock on hand, dispatch is typically 7-14 working days from confirmed order — slightly longer than small-molecule lines because every consignment requires cold-chain shipper qualification, data logger commissioning and pre-dispatch MKT validation. For tender awards (Global Fund chemo-supportive procurement scoping, Africa CDC, NUPCO, KEMSA, CMS Ghana), the lead time is set in the tender award document. For UK NHS oncology pharmacy ad-hoc supply with urgency flagged, validated cold-chain air-freight out of Mumbai can be on a flight within 96 hours. Made-to-order biosimilar batches run 10-16 weeks inclusive of QC release, biosimilar comparability batch testing and destination artwork. Cold-chain 2-8°C is mandatory throughout — every consignment carries a continuous in-transit data logger reviewed against the SmPC excursion limits at receipt.