Insulin glargine biosimilar — Indian WHO-GMP supply for NHS, GCC and African diabetes programmes.
Long-acting recombinant human insulin analogue, the original 24-hour basal insulin (Lantus generic). 100 IU/ml SoloStar prefilled pens + 10ml multi-use vials from Indian WHO-GMP biosimilar facilities, with EMA / MHRA biosimilar comparability dossier on file, 2-8°C cold-chain validated end-to-end, and 50-70% pricing below the originator that opens basal-insulin access in tender markets globally.
Multiple WHO-GMP biosimilar partner lines · 100 IU/ml SoloStar pens + 10ml vials · CTD biosimilar comparability dossier on file · 2-8°C cold-chain validated.
Active ingredient
Insulin glargine, a recombinant human insulin analogue produced in non-pathogenic E. coli or Pichia pastoris. Three modifications differentiate it from human insulin: glycine substitution at A21 + two arginine additions at B-chain C-terminus. These modifications shift the isoelectric point to physiological pH, causing micro-precipitation at the SC injection site that slowly redissolves over 24 hours — producing the flat, peakless basal profile.
Strengths stocked
100 IU/ml in 3ml SoloStar prefilled disposable pen (most-prescribed format globally — patient-friendly, single-use, dial-a-dose 1-80 units); 100 IU/ml in 10ml multi-use vial (insulin pump fills, hospital ward stock, paediatric dose titration with insulin syringes). The 300 IU/ml Toujeo concentration (separate biosimilar listing) is for higher daily-dose patients (>40 IU) — smaller injection volume, slightly different PK profile from 100 IU/ml glargine.
Indications
T1DM basal component (with rapid-acting analogue at meals); T2DM basal when oral agents inadequate; T2DM basal-plus / basal-bolus intensification; off-label gestational diabetes; paediatric T1DM ≥6 years (≥2 years in some jurisdictions). Once-daily SC injection, typically 0.2-0.4 IU/kg/day starting dose, titrated to fasting glucose target.
Storage
Unopened: 2-8°C, do not freeze, protect from light. Once opened (in-use): up to 28 days at room temperature ≤30°C, no refrigeration required (refrigeration of in-use pens is permitted but causes injection-site discomfort). Frozen insulin is permanently denatured and must be discarded. End-of-shelf-life inspection: clear colourless solution; discard if cloudy, discoloured or with visible particles.
Shelf life
30 months from manufacture; minimum 24 months at dispatch. Or we won't ship it.
Pack format
SoloStar prefilled pens: 5 pens per carton, hospital pack. Vials: single vial per carton (10ml). Outer carton and leaflet in destination-regulator language. Biosimilar batch-traceability label per EMA / MHRA biosimilar pharmacovigilance requirement (lot number printed on outer carton AND patient leaflet for traceability across switching).
Hospital pharmacies, diabetes clinics and tender desks across thirty markets.
India is our origin. We do not sell into the Indian market. Insulin glargine biosimilar is exported only.
United Kingdom
NHS England biosimilar switch policy mandates biosimilar insulin glargine as first-line for new T1DM and T2DM patients since 2018 (Abasaglar / Semglee biosimilars dominant). 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. Diabetes UK + NICE NG28 biosimilar substitution guidance documented in the pre-dispatch pack.
GCC (UAE, KSA, Kuwait, Oman, Qatar, Bahrain)
Through local licensed importers, against MoH biosimilar diabetes tender awards (NUPCO biosimilar diabetes tenders are a major channel — Saudi MoH biosimilar substitution policy since 2019; MoHAP, DHA and DOH Abu Dhabi for UAE — Cleveland Clinic Abu Dhabi diabetes programme is a key buyer; Kuwait MoH Central Drug Store; MoPH Qatar including Hamad Medical Corporation; MoH Oman; NHRA Bahrain). GCC has among the highest T2DM prevalence rates globally — basal insulin tender volumes are substantial. SFDA, MoHAP and GCC central registration support the biosimilar comparability dossier filing.
Nigeria, Kenya, Ghana, South Africa, Ethiopia
Public-sector diabetes biosimilar tenders (NAFDAC for Nigeria, KEMSA + MEDS for Kenya, FDA Ghana + Central Medical Stores, SAHPRA for South Africa — Netcare and Mediclinic diabetes centres are key buyers, EFDA + EPSS for Ethiopia). Diabetes is a fast-growing public-health burden in sub-Saharan Africa with expanding national insulin programmes. WHO PEN protocols, IDF Africa region tenders, and ADDRESS-2 / Life for a Child donor programmes all source biosimilar insulin glargine through Indian WHO-GMP suppliers.
Germany, France, Brazil, Mexico, Philippines
Supply via licensed importers under §72 AMG (Germany — biosimilar-substitution policy stricter than UK), ANSM equivalent (France), ANVISA biosimilar (Brazil), COFEPRIS (Mexico), FDA Philippines, with Qualified Person (QP) biosimilar certification on EU arrival. EMA biosimilar comparability dossier prepared per EMA/CHMP/BMWP/32775/2005 (insulin biosimilar guideline).
Cold-chain integrity, no mixing, basal-bolus discipline — insulin glargine is forgiving but requires the storage and timing fundamentals.
Adult starting dose for T2DM is 0.1-0.2 IU/kg/day SC once daily, titrated by 2-4 IU every 3 days to fasting glucose target (typically 4-7 mmol/L per individualised clinical target). T1DM basal component is typically 40-50% of total daily insulin requirement (with rapid-acting analogue covering the remainder at meals). Once-daily timing is patient-preference (morning or evening — both produce equivalent 24-hour basal coverage); fixed-time-of-day discipline matters more than which time of day. Cannot be mixed in syringe with other insulins — the acidic pH (4.0) of glargine is incompatible with neutral-pH rapid-acting analogues; separate injection sites mandatory. Cold-chain integrity is the dispensing gate: pharmacy stock 2-8°C, in-use pens 28 days at ≤30°C ambient, frozen insulin permanently denatured (binned). Hypoglycaemia risk is lower than with NPH but real — basal insulin overdose causes prolonged 12-24 hour hypoglycaemia requiring extended IV glucose monitoring; family / caregiver education on glucagon rescue is standard. Biosimilar-to-originator switching is well-tolerated in clinical practice; same-day switching is the EMA biosimilar interchangeability guidance. Lipohypertrophy (fat-tissue lump at habitual injection site) is the most common SC complication — site rotation discipline (8-point clock pattern, change quadrant daily) is the prevention; lipohypertrophy reduces absorption predictability. Travel guidance: keep pens in carry-on luggage (cargo holds may freeze at altitude); GTC airlines accept insulin in liquids exemption with prescription documentation.
The documentation pack a regulator actually asks for — biosimilar comparability + insulin-specific PK/PD bridging.
Insulin glargine biosimilar is a complex recombinant biological — the regulatory pack is more demanding than a small-molecule generic. Our role is manufacturer-facing — we sit between the Indian WHO-GMP biosimilar facility and your clinical, regulatory or procurement team and take the paperwork off both sides.
CTD Module 3 + biosimilar comparability
Full chemistry, manufacturing and controls section per ICH Q5A-Q5E and EMA insulin biosimilar guidelines (CHMP/BMWP/32775/2005). Biosimilar comparability covers physico-chemical characterisation (peptide mapping, IEF, CE-SDS, mass spectrometry of the modified A21 + B-chain residues), in-vitro receptor binding (insulin receptor + IGF-1 receptor affinity), euglycaemic clamp PK/PD bridging study in healthy volunteers, and clinical bridging study in T1DM or T2DM patients.
CoA and MoA, per batch
RP-HPLC assay (≥97% glargine, related insulin species ≤3%), peptide mapping LC-MS/MS, IEF, CE-SDS, deamidation product profile, A21 and B-chain modification confirmation, host-cell protein (CHO or E. coli HCP), residual host-cell DNA, sterility, bacterial endotoxin, particulate matter, in-use stability — 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.
Pack insert, labels, artwork
Destination-language PIL, labelling to local regulator standards (MHRA SmPC style for the UK, MoH style for GCC, SAHPRA for South Africa, BfArM for Germany). Biosimilar batch-traceability label per EMA / MHRA biosimilar pharmacovigilance requirement. Cold-chain storage instructions, in-use-stability guidance, and lipohypertrophy injection-rotation guidance prominently set on the patient leaflet.
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. Cold-tail (freezing) is the catastrophic excursion mode — frozen glargine is permanently denatured. 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. Severe hypoglycaemia, lipohypertrophy, allergic reactions to recombinant insulin or to formulation excipients (m-cresol, glycerol), and insulin-induced weight gain remain the PSUR priority signals.
Basal-bolus, T2DM oral combos, and the biosimilar diabetes cluster.
Insulin glargine pairs with rapid-acting analogues at meals (T1DM basal-bolus) or with metformin + DPP4 / SGLT2 / GLP-1 in T2DM step-up regimens.
Insulin lispro / aspart
Rapid-acting analogue, mealtime bolus partner to glargine. Separate biosimilar listing.
Metformin
First-line oral T2DM. 500mg / 850mg / 1000mg tablets + extended-release.
Empagliflozin
SGLT2 inhibitor, T2DM + HFrEF + CKD. 10mg / 25mg tablets.
Sitagliptin
DPP4 inhibitor, T2DM step-up. 25mg / 50mg / 100mg tablets.
All diabetes-endocrine →
60+ diabetes-endocrine SKUs: insulins, oral antidiabetics, GLP-1, thyroid, adrenal, growth hormone.
Haematology / Biologicals →
Biological cluster — albumin, IVIg, EPO biosimilars, factor concentrates.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Format (SoloStar prefilled pen / 10ml multi-use vial), pen or vial count, destination, NHS biosimilar formulary / GCC NUPCO biosimilar tender / African public-sector / NGO supply, target delivery. Flag if biosimilar comparability dossier or NICE NG28 / Diabetes UK biosimilar-substitution compliance set is needed.
- We route to the right line. Multiple WHO-GMP biosimilar insulin glargine 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 Lantus), lead time, biosimilar comparability dossier status per destination, 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 with cold-tail (freeze) excursion protocol, 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 hypoglycaemia, lipohypertrophy and allergic reactions remain the PSUR priority signals.
Insulin glargine biosimilar supply — the specific questions.
What strengths and formats of insulin glargine do you supply?
100 IU/ml in 3ml SoloStar prefilled disposable pen (the most-prescribed format globally — patient-friendly, single-use, dial-a-dose 1-80 units, 5 pens per carton). 100 IU/ml in 10ml multi-use vial (for insulin pump fills, hospital ward stock, paediatric dose titration with insulin syringes). The 300 IU/ml Toujeo concentration (smaller injection volume for higher daily-dose patients) is a separate biosimilar listing in our diabetes catalogue. Pack is one vial per carton or 5 pens per carton.
Is your insulin glargine biosimilar approved by EMA / MHRA?
We supply biosimilar insulin glargine from manufacturers that hold EMA biosimilar approvals (CHMP positive opinions issued from 2014 onwards — Abasaglar/Lusduna lineage; Semglee 2018) and MHRA biosimilar approvals. Specific manufacturer EMA/MHRA approval status is shared against NDA per consignment. The EMA biosimilar pathway for insulin per CHMP/BMWP/32775/2005 covers physico-chemical characterisation, in-vitro receptor binding, euglycaemic clamp PK/PD bridging, and clinical bridging in T1DM or T2DM patients — the manufacturer-side comparability dossier is included in destination registration filing.
Can biosimilar insulin glargine be substituted for branded Lantus mid-treatment?
Yes — per EMA biosimilar interchangeability guidance and the NICE NG28 biosimilar-substitution recommendation, biosimilar insulin glargine can be substituted for the originator at any treatment stage with no clinical-impact difference. NHS England has run biosimilar switch programmes since 2018 with documented sustained glycaemic control across switched patients. Our destination-language SmPC carries the biosimilar interchangeability declaration. The dispensing-side responsibility (patient counselling on the brand change) sits with the dispensing pharmacy; the manufacturer-side responsibility (clear biosimilar labelling + batch traceability) is ours.
Which markets can you ship insulin glargine biosimilar into?
The UK (NHS biosimilar formulary supply, MHRA-aligned biosimilar lines), the GCC (UAE, Saudi Arabia, Kuwait, Oman, Qatar, Bahrain) through licensed local importers — biosimilar diabetes tender channel is the primary route given the high regional T2DM prevalence — sub-Saharan Africa (Nigeria, Kenya, Ghana, South Africa, Ethiopia) for public-sector diabetes tenders + IDF Africa region programmes + Life for a Child donor scheme, 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 an insulin glargine biosimilar consignment?
Every consignment ships with a batch-specific Certificate of Analysis (RP-HPLC assay, peptide mapping LC-MS/MS, IEF, CE-SDS, deamidation product profile, A21 and B-chain modification confirmation, host-cell protein, residual host-cell DNA, sterility, bacterial endotoxin, particulate matter, in-use stability), 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 + cold-chain storage instructions + in-use-stability guidance + lipohypertrophy injection-rotation guidance, and cold-chain temperature logs from pre-dispatch through on-arrival. Biosimilar-specific PV contact nominated on registration.
Do you provide CTD biosimilar comparability dossiers for insulin glargine registration?
Yes. Full CTD Module 3 plus biosimilar comparability annex per EMA CHMP/BMWP/32775/2005 (insulin biosimilar guideline) is available against a non-disclosure agreement, for registration with MHRA, GCC central registration, SFDA, MoHAP, NAFDAC, PPB, SAHPRA, EFDA, BfArM, ANSM, ANVISA, COFEPRIS, FDA Philippines and comparable bodies. The comparability exercise covers physico-chemical characterisation, in-vitro insulin and IGF-1 receptor binding, euglycaemic clamp PK/PD bridging study, and clinical bridging in T1DM or T2DM. Lead time on a biosimilar dossier against a new registration is typically 8-12 weeks given the complexity. See dossier preparation.
What are typical lead times for insulin glargine 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 (NHS biosimilar framework, NUPCO, KEMSA, SAHPRA, IDF Africa programmes, Life for a Child), the lead time is set in the tender award document. Biosimilar insulin manufacturing has a long upstream cell-culture cycle (10-14 weeks) so made-to-order batches run 12-16 weeks inclusive of QC release and destination artwork. 2-8°C cold-chain is mandatory throughout transit, no freezing — frozen insulin is permanently denatured. Active-cooled 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.
Format (SoloStar pen / 10ml vial), pen or vial volume, destination, NHS biosimilar formulary / GCC NUPCO tender / African public-sector / IDF Africa programme, target delivery, biosimilar comparability dossier requirement. That's the enquiry. Everything else is on us.