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Is Poherdy available in India? Status, route and cost

A plain answer for families in India, 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 India?

We have not checked Poherdy's registration with India's regulator, CDSCO, so ask the treating hospital to confirm it. Poherdy is a biosimilar to Perjeta for HER2-positive breast cancer, given by infusion. For a medicine not available in India, CDSCO can permit a small personal-use import under Rule 36, applied for on Form 12A.

Registration: Not checked by us; ask the treating hospital to confirm it with CDSCO.
Access route: Personal-use import permission from CDSCO, on a doctor's prescription.
Who acts: the patient or family applies to CDSCO on Form 12A, with the prescription of a registered medical practitioner.
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)
CDSCO's personal-use procedure: application on Form 12A, permit on Form 12B, no fee, issued on priority, preferably within a day or two. (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 India

The application is made on Form 12A, with a prescription from a registered medical practitioner that shows the doctor's registration number, the medicine name, the quantity and the duration of treatment. If CDSCO agrees, it issues the permit on Form 12B. The quantity must be reasonable and match the prescription.

The application goes to the CDSCO port office where the medicine will arrive. CDSCO lists offices including New Delhi, Mumbai, Chennai, Kolkata, Hyderabad, Bengaluru, Ahmedabad and Cochin. CDSCO's procedure says no fee is charged for this permission, and that it is issued on priority, preferably within a day or two once the file is complete.

We have not checked this medicine against CDSCO's approvals. Ask the treating hospital to confirm its current status in India before anything is filed, and confirm the current Form 12A procedure with CDSCO.

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 CDSCO with the documents below, unless a hospital applies for an institutional permission instead.
The Central Drugs Standard Control Organisation (CDSCO) 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 CDSCO.
Permission. CDSCO 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. CDSCO's procedure says the personal-use permission is issued on priority, preferably within a day or two once the file is complete.

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 CDSCO approves.

Ask about Poherdy in India

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 India?

How do patients in India get Poherdy?

India's national drug regulator is the Central Drugs Standard Control Organisation (CDSCO). Under Rule 36 of the Drugs and Cosmetics Rules, 1945, CDSCO can permit the import of small quantities of a medicine for a patient's personal use. CDSCO's procedure note says that, for a medicine not approved in India, this permission is meant for the patient's own treatment where it is needed to save life. The application is made on Form 12A, with a prescription from a registered medical practitioner that shows the doctor's registration number, the medicine name, the quantity and the duration of treatment. If CDSCO agrees, it issues the permit on Form 12B. The quantity must be reasonable and match the prescription.

How long does it take to get Poherdy in India?

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. CDSCO's procedure says the personal-use permission is issued on priority, preferably within a day or two once the file is complete.

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.