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Pertuzumab

Medicine

Extended indication Indicated for use in combination with trastuzumab and chemotherapy in: • The neoadjuvant treatment of adult patients with HER2-positive, locally adva
Therapeutic value Possible equal value
Registration phase Registered

Product

Active substance Pertuzumab
Domain Oncology
Reason of inclusion Biosimilar BS
Main indication Breast cancer
Extended indication Indicated for use in combination with trastuzumab and chemotherapy in: • The neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence. • The adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence. It is also indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Current proprietary name Perjeta (Roche)
Proprietary name Poherdy
Manufacturer Organon
Portfolio holder Organon
Route of administration Intravenous
Therapeutical formulation Intravenous drip
Budgetting framework Intermural (MSZ)
Additional remarks Gehumaniseerd IgG1 monoclonaal antilichaam gericht tegen HER2.

Registration

Registration route Centralised (EMA)
Type of trajectory Normal trajectory
Particularity Biosimilar
ATMP No
Submission date March 2025
Expected Registration April 2026
Orphan drug No
Registration phase Registered
Additional remarks Positieve opinie CHMP februari 2026, EC registratie april 2026.

Therapeutic value

Current treatment options Trastuzumab zonder pertuzumab
Therapeutic value Possible equal value

This assessment does not indicate any potential inclusion in the package.
Substantiation biosimilar
Duration of treatment Average 12 month / months
Frequency of administration 1 times every 3 weeks
Dosage per administration 420 mg
References Von Minckwitz et al. N Engl J Med 2017; 377:122-131.
Additional remarks Eerste toediening 840mg

Expected patient volume per year

Patient volume < 1,119

Market share is generally not included unless otherwise stated.
References NKR
Additional remarks Aantal diagnoses stadium 2/3 HER+ in 2016

Expected cost per patient per year

Potential total cost per year

Off label use

Off label use No

Indication extension

Indication extensions No

Other information