Pertuzumab Drug Substance Suppliers & Bulk Manufacturers

Available Forms: Drug substance (bulk)

Available Strengths: Supplied to an in-house or pharmacopoeial specification

Reference Brands: Perjeta, Phesgo

Category: Active Pharmaceutical Ingredient

Pertuzumab is a humanised IgG1 antibody against the HER2 dimerisation domain, used in HER2-positive breast cancer. It is sourced by biosimilar developers and biologics CDMOs.

Product Description:

Pertuzumab is a humanised monoclonal antibody that binds subdomain II of HER2, the region the receptor uses to pair with other HER family receptors, so it blocks signalling in a way that complements trastuzumab. With trastuzumab and chemotherapy it is approved for HER2-positive metastatic breast cancer not previously treated with anti-HER2 therapy or chemotherapy for metastatic disease, and for neoadjuvant and high-risk adjuvant treatment of HER2-positive early breast cancer (reference brand: Perjeta). A subcutaneous fixed-dose combination with trastuzumab and hyaluronidase is also approved (reference brand: Phesgo).

Specification at a glance

Regulatory files and timing

Biologic drug substance is usually supplied in bulk under a long-term supply agreement, or licensed together with the dossier, rather than bought as a one-off API order. Buyers typically ask for the drug substance comparability package, cell bank and process documentation, and the supplier's GMP status.

Generic or biosimilar entry. United States: Entry expected (not before 2028). European Union: Entry expected (not before 2027). Sources and updates are on our generic and biosimilar entry tracker.

Handling and quality points

Pertuzumab drug substance needs a validated cold chain, with storage and shipping conditions set by the developer's stability data; the finished product is kept at 2 to 8 °C, protected from light, and must not be frozen or shaken. Similarity work centres on HER2 binding, inhibition of HER2 dimerisation and cell growth, Fc-related functions, glycosylation and charge variants. Buyers should also review cell bank history, viral safety and clearance of host-cell proteins and DNA.

Send an API enquiry All specialty APIs

Brand names are trademarks of their respective owners and identify the reference medicine only. Information is general and was checked in October 2026; confirm specifications and filings with the supplier before purchase.