Pembrolizumab (Keytruda) is heading into its 2028 to 2031 patent cliff just as a newly approved subcutaneous co-formulation extends fresh protection around it.
Pembrolizumab, sold under the brand Keytruda, is Merck's PD-1 checkpoint inhibitor and the world's highest-revenue oncology biologic. Its core composition-of-matter patent expires in the United States around 2028 and in the European Union around 2030 to 2031, and Merck has layered new protection onto a subcutaneous co-formulation the FDA approved in September 2025. Until a biosimilar clears review in a given market, buyers are sourcing the originator line. M Care Exports supplies pembrolizumab sourced from WHO-GMP certified Indian manufacturers, quoted to the buyer's own registered label and destination filing.
Pembrolizumab exporter and bulk supplier from India.
Pembrolizumab ships as a single-dose vial requiring refrigerated (2C to 8C) cold-chain transport from origin to destination pharmacy, with temperature logging maintained across every leg of the export and checked again on arrival. M Care Exports prepares the destination-market documentation set: certificate of pharmaceutical product, certificate of analysis, batch release documentation and cold-chain validation records, matched to the buyer's own registered label and national drug authority filing. Because pembrolizumab is a biologic under active patent protection in most regulated markets, we quote the current originator or a licensed line as confirmed at enquiry, never a fixed stock position. Export documentation is prepared per shipment; specific line, batch and packaging configuration are confirmed directly with the buyer before any quotation is finalised.
Source
WHO-GMP-certified Indian manufacturing line, named on every quote.
Minimum order
No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.
Pricing
On request. Indicative FOB or CIF quote, formal proforma on confirmation.
Incoterms
EXW, FOB, CIF, CIP or DAP.
Payment
Letter of credit (sight or usance) and telegraphic transfer.
Documentation
WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.
Shelf-life
Minimum remaining shelf-life agreed per order and confirmed on the proforma.
Response
Availability and CoPP status within two working days; pre-alert documents before dispatch.
PD-1 (programmed death receptor-1) blocking humanized IgG4 monoclonal antibody (immune checkpoint inhibitor), sourced and documented for export.
Pembrolizumab's patent position is unusually layered for a single molecule. The core composition-of-matter patent is due to expire in the United States around 2028 and in the European Union around 2030 to 2031, but Merck has built a wider estate of formulation, dosing-regimen and method-of-use patents around both the original intravenous product and the subcutaneous co-formulation, marketed as Keytruda Qlex, that the FDA approved in September 2025. Clinically, pembrolizumab is a humanized IgG4 monoclonal antibody that blocks the PD-1 receptor, restoring T-cell activity against tumor cells across dozens of solid-tumor indications. It was also the first drug the FDA approved on a tumor-agnostic basis, for MSI-High or mismatch-repair-deficient solid tumors regardless of where the tumor originated, a precedent that reshaped how later checkpoint inhibitors were developed and labeled.
Active ingredient
Pembrolizumab. PD-1 (programmed death receptor-1) blocking humanized IgG4 monoclonal antibody (immune checkpoint inhibitor).
Forms and strengths
100 mg.
Indications
Pembrolizumab is a humanized monoclonal antibody that blocks the PD-1 receptor on T cells, restoring anti-tumor immune activity. The originator IV presentation is a 100 mg/4 mL (25 mg/mL) single-dose vial. A separately approved subcutaneous co-formulation exists in some markets under its own registration and is not interchangeable with the IV vial.
Administration
Intravenous infusion, Subcutaneous injection (separately registered co-formulation). Solution for infusion, single-dose vial (IV); subcutaneous co-formulation separately registered in some markets.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
Hospital pharmacies, licensed importers and tender desks across our export markets.
India is our origin. We do not sell into the Indian market.
Pembrolizumab moves through hospital oncology pharmacies, cancer-centre tender desks and licensed importers across the UK and EU, Gulf and GCC states, Africa, Latin America, Southeast Asia and the CIS. Buyers are typically regulatory affairs teams preparing a variation or import filing, hospital procurement groups running an oncology tender, and licensed wholesalers restocking a checkpoint-inhibitor line ahead of a cycle of protocol renewals. Because pembrolizumab is dosed on a fixed or weight-based schedule across many solid-tumor protocols, orders tend to come from institutions with an existing oncology formulary rather than first-time buyers. India is the country of origin only; M Care does not sell into the Indian domestic market.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on pembrolizumab.
A reviewing pharmacist checks that the supplied presentation matches the buyer's registered dossier: the originator vial is 100 mg/4 mL (25 mg/mL) for intravenous infusion, formulated with L-histidine, polysorbate 80 and sucrose, with no preservative, so any partial vial must be discarded after single use. Diluted infusion solution has a defined stability window at room temperature or under refrigeration, which should be checked against the current label rather than assumed. Because pembrolizumab restores T-cell activity broadly rather than only against tumor tissue, the label carries extensive warnings for immune-mediated adverse reactions: pneumonitis, colitis, hepatitis, endocrinopathies including thyroid and adrenal dysfunction, nephritis and dermatologic reactions, plus a caution on complications of allogeneic haematopoietic stem cell transplantation in patients who have received pembrolizumab. A pharmacist reviewing the subcutaneous co-formulated line should confirm it carries a separate registration in the destination market, since its fixed-dose strength and injection volume differ from the intravenous vial and the two are not interchangeable under one authorisation.
The documentation pack a regulator actually asks for.
Every pembrolizumab shipment is accompanied by a certificate of pharmaceutical product from the country of manufacture, a batch-specific certificate of analysis, cold-chain shipping validation and, where the destination authority requires it, a free-sale certificate. M Care Exports itself holds ISO 9001:2015 certification and a CDSCO export licence; it is a merchant-exporter and does not manufacture pembrolizumab or hold WHO-GMP or WHO-PQ certification in its own name. Sourced product comes from Indian manufacturing sites holding WHO-GMP certification, verified against the specific line quoted. Because pembrolizumab is a biologic, buyers should expect batch-to-batch analytical variation within approved specification ranges rather than the fixed chemical identity of a small molecule, and destination filings should reference the buyer's own registered dossier rather than the country of origin's label. Where the subcutaneous co-formulation is requested, its registration status is checked separately per market, since as a newer approval it may not yet be registered everywhere the intravenous product is.
CoA and MoA, per batch
Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.
CoPP, WHO-GMP, MFG licence
Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.
CTD Module 3
Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.
Pack insert, labels, artwork
Destination-language patient information and labelling to the local regulator's standard, locked before shipment.
Pharmacovigilance
A named PV contact arranged in the destination market where the registration requires one.
What a buyer should know before this line enters a formulary.
We publish the awkward facts alongside the useful ones. A supplier who omits them is not saving you work, only deferring it.
Prescription-only biologic; administered under oncology specialist supervision
Immune-mediated adverse reactions (pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, dermatologic reactions) documented in Warnings and Precautions on the approved label; no boxed warning
Cold-chain (2C to 8C) storage and transport required; diluted IV infusion solution has a defined, label-specific stability window
No pembrolizumab biosimilar approved in the US or EU as of mid-2026; core composition-of-matter patent under active protection until approximately 2028 (US) and 2030 to 2031 (EU)
Subcutaneous co-formulation (Keytruda Qlex, with berahyaluronidase alfa), FDA approved September 2025, is a separately approved product, not interchangeable with the intravenous vial, and may not be registered in every destination market
M Care Exports is a merchant-exporter; holds ISO 9001:2015 and a CDSCO export licence only, not WHO-GMP or WHO-PQ certification
Adjacent lines procurement desks order alongside pembrolizumab.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for pembrolizumab.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Pembrolizumab supply, the specific questions.
Is pembrolizumab available as a biosimilar yet?
No pembrolizumab biosimilar is approved in the United States or European Union as of mid-2026. The core patent is expected to expire in the US around 2028 and in the EU around 2030 to 2031, and several manufacturers have biosimilar programmes in late-stage clinical trials, with earliest regulatory submissions plausible in 2026 to 2027. Until a biosimilar clears review in a given market, M Care quotes the originator or a licensed line as confirmed at enquiry.
What is the difference between the intravenous and subcutaneous formulations?
The original formulation is a 100 mg/4 mL single-dose vial given by intravenous infusion. A subcutaneous co-formulation with berahyaluronidase alfa, marketed as Keytruda Qlex and approved by the FDA in September 2025, is a separate fixed-dose product given by injection rather than infusion. The two are not interchangeable and are typically registered under distinct approvals in each destination market.
What is pembrolizumab's main safety concern for a buyer's regulatory file?
Pembrolizumab carries prominent warnings for immune-mediated adverse reactions, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and skin reactions, because it activates T-cell immunity broadly rather than only against tumor tissue. These are documented in Warnings and Precautions rather than a boxed warning, but destination labelling and pharmacovigilance reporting should reflect them in full.
Does M Care hold WHO-GMP or WHO-PQ certification directly?
No. M Care Exports is a merchant-exporter, not a manufacturer, and holds ISO 9001:2015 certification and a CDSCO export licence in its own name. Pembrolizumab is sourced from Indian manufacturing sites that hold WHO-GMP certification, and that certification is verified against the specific manufacturing line supplied, not claimed by M Care itself.
Which markets does M Care supply pembrolizumab into?
M Care supplies licensed importers, hospital pharmacies and tender desks in the UK and EU, Gulf and GCC states, Africa, Latin America, Southeast Asia and the CIS. India is the country of origin only; M Care does not sell into the Indian domestic market.
Can M Care supply pembrolizumab under a named-patient or parallel-import route?
Yes, where that is the applicable route for a given destination market. Named-patient and parallel-import supply for oncology biologics follows the buyer's own national framework, and M Care prepares the corresponding documentation set for that route as part of its regulatory support service.
What documentation accompanies a pembrolizumab shipment?
Each shipment carries a certificate of pharmaceutical product, a batch-specific certificate of analysis, cold-chain shipping validation records and, where required, a free-sale certificate, all matched to the buyer's own registered label and destination filing rather than a generic export template used across unrelated molecules.
Is the tumor-agnostic MSI-H approval relevant to every market M Care supplies into?
The FDA's tumor-agnostic approval for MSI-High or mismatch-repair-deficient solid tumors, first granted in 2017, is a US-specific regulatory pathway. Other regulators evaluate biomarker-driven indications under their own frameworks and timelines, so buyers should confirm which indications are actually registered in their destination market rather than assuming the US label applies.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-08-22.
This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.
Send the specifics. You'll have a price inside one working day.
Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.