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Is Poherdy available in Sri Lanka? Status, route and cost

A plain answer for families in Sri Lanka, checked against FDA, regulator and manufacturer sources on 17 October 2026.

Reviewed by the Reserve Meds clinical operations team on 17 October 2026.

Is Poherdy available in Sri Lanka?

We have not checked Poherdy's registration with Sri Lanka's NMRA, so ask the treating hospital to confirm it. Poherdy is a biosimilar to Perjeta for HER2-positive breast cancer, given by infusion. When a medicine is not registered or not available in Sri Lanka, NMRA can allow its import through a personal user letter of authorization.

Registration: Not checked by us; ask the treating hospital to confirm it with NMRA.
Access route: Personal-use import permission from NMRA, on a doctor's prescription.
Who acts: the patient or guardian applies to NMRA for a personal user letter of authorization, with a form signed by the prescriber.
Timeline: We give you a written timeline estimate for your case before you commit.
Price: Medicine price: quote on request. You get a written quote for your case before you commit.

Status, with dates

The FDA announced Poherdy's approval on 13 November 2025, as the first biosimilar to Perjeta and interchangeable with it. (source)
NMRA's personal user letter of authorization: no NMRA fee, up to 100 doses per personal user licence. (source)
NMRA notice to applicants for personal user authorization letters, dated 6 September 2021. (source)

What Poherdy is

Poherdy (pertuzumab-dpzb) is a biosimilar to Perjeta (pertuzumab). It is made by Shanghai Henlius Biotech and distributed in the US by Organon. The FDA announced its approval on 13 November 2025 as the first biosimilar to Perjeta, and also as interchangeable with Perjeta. In the US, interchangeable means a pharmacy may substitute it for Perjeta without contacting the prescriber, where state pharmacy law allows. Other countries set their own rules.

It is used together with trastuzumab and chemotherapy in adults with HER2-positive breast cancer: for metastatic breast cancer, with trastuzumab and docetaxel, when no anti-HER2 therapy or chemotherapy has been given for metastatic disease; before surgery (neoadjuvant) for locally advanced, inflammatory or early-stage breast cancer that is larger than 2 cm or has spread to lymph nodes; and after surgery (adjuvant) for early breast cancer at high risk of coming back.

How it is given and safety

It is given by intravenous infusion: a first dose of 840 mg over 60 minutes, then 420 mg every 3 weeks over 30 to 60 minutes. It comes as a 420 mg/14 mL single-dose vial that must be kept in a refrigerator at 2°C to 8°C, protected from light, and not frozen or shaken. Any shipment therefore needs a cold chain.

The US label has a boxed warning. Pertuzumab products can weaken the heart's pumping (a fall in LVEF, or heart failure), so heart function is checked before and during treatment. Exposure during pregnancy can cause the loss of the baby or birth defects. Other serious risks are infusion reactions and allergic reactions. Common side effects include diarrhea, hair loss, low white blood cell counts, nausea and tiredness.

How access works in Sri Lanka

NMRA asks for a copy of a valid prescription from a registered medical professional; a request letter from the patient or guardian with the patient's name and address, the medicine names, the quantity and contact details; a copy of the patient's or guardian's NIC, passport or driving licence; and an application form signed by the prescriber.

NMRA says it charges no fee for this, and that up to 100 doses can be imported under one personal user licence. Applications are sent by email or handed in at NMRA. The email addresses on NMRA's notices differ, so confirm the current address with NMRA before you send documents.

We have not checked this medicine against NMRA's register. Ask the treating hospital to confirm its current status in Sri Lanka before anything is filed.

Who does what

Your treating doctor decides whether Poherdy is right for the patient and writes the prescription the application needs.
The patient or family applies to NMRA with the documents below, unless a hospital applies for an institutional permission instead.
The National Medicines Regulatory Authority (NMRA) decides whether to permit the import, and how much.
The hospital or clinic gives the infusion and monitors the patient.
Reserve Meds helps you prepare the file, and where the import is permitted, arranges US supply through our licensed wholesale partner. We do not give medical advice.

Documents you will usually need

The pathology report confirming HER2-positive breast cancer, with the stage
A recent heart function result (LVEF), because the label requires a heart check before treatment
The oncologist's treatment plan, including the trastuzumab and chemotherapy that will be given with it
Identity documents for the patient (and the applicant, if different), as the regulator asks
The prescription from a registered medical practitioner, with the doctor's registration number, the medicine, the quantity and the duration

Steps

Prescription. Your doctor writes the prescription and a short clinical summary for Poherdy.
Application. The patient or family sends the application and documents to NMRA.
Permission. NMRA reviews the file and issues its permission, or asks for more information.
US sourcing. Our US-licensed wholesale partner supplies the medicine, shipped refrigerated at 2°C to 8°C.
Treatment. The hospital gives the infusion and checks heart function as the label requires.

Timeline and cost

We give you a written timeline estimate for your case before you commit. The regulator, the hospital and the manufacturer set their own timelines.

Medicine price: quote on request. You get a written quote for your case before you commit. Your total cost depends on the dose, shipping, import steps and coordination. Your coordination fee is quoted in writing for your case before you commit. No hidden charges.

How Reserve Meds helps

Reserve Meds is a digital health company. Medicines are supplied through a US-licensed pharmaceutical wholesale partner. We coordinate access to FDA-approved medicines only. We help your family understand the route, organize records and communication with the doctor and hospital, and, where an import is approved, arrange US supply and refrigerated (2°C to 8°C) shipping through our licensed wholesale partner. Delivery follows the terms of the import approval and is confirmed in writing before you commit. We do not prescribe, and we do not decide what NMRA approves.

Ask about Poherdy in Sri Lanka

Tell us the medicine, your country and a WhatsApp or phone number. We reply within one business day. On WhatsApp we usually reply the same day.

Frequently asked questions

Is Poherdy registered in Sri Lanka?

We have not checked this medicine against NMRA's register. Ask the treating hospital to confirm its current status in Sri Lanka before anything is filed.

How do patients in Sri Lanka get Poherdy?

In Sri Lanka, the National Medicines Regulatory Authority (NMRA) allows a medicine that is not registered or not available in the country to be imported through a personal user letter of authorization. NMRA asks for a copy of a valid prescription from a registered medical professional; a request letter from the patient or guardian with the patient's name and address, the medicine names, the quantity and contact details; a copy of the patient's or guardian's NIC, passport or driving licence; and an application form signed by the prescriber.

How long does it take to get Poherdy in Sri Lanka?

We give you a written timeline estimate for your case before you commit. The regulator, the hospital and the manufacturer set their own timelines, and we tell you honestly what depends on them.

How much does Poherdy cost?

Medicine price: quote on request. You get a written quote for your case before you commit. Your total cost, including shipping, import steps and coordination, is quoted in writing before you commit. No hidden charges.

Is Poherdy the same as Perjeta?

Poherdy is a biosimilar to Perjeta, approved by the FDA as interchangeable with it in the US. Both contain pertuzumab and have the same uses on the US label. Whether one can replace the other in your country is decided by the local regulator and your oncologist.

Sources

Checked on 17 October 2026. Regulator rules and lists change. Your doctor, hospital pharmacy or the regulator confirms the current position before anything is filed.