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FDA approved Poherdy (pertuzumab-dpzb) injection as an interchangeable biosimilar biological product to Perjeta (pertuzumab). Poherdy (pertuzumab-dpzb) is the first biosimilar approved for Perjeta (pertuzumab).

Poherdy is approved for the following treatment indications in adults, which are also currently approved for Perjeta:

use in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease.
use in combination with trastuzumab and chemotherapy as
- neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (either greater than 2 cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.
- adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.

Poherdy is a HER2/neu receptor antagonist that targets subdomain II of HER2 (as opposed to subdomain IV where trastuzumab binds), blocking ligand-dependent signaling pathways, which can result in cell growth arrest and cell death. In addition, like trastuzumab, it can also initiate cell death through antibody-dependent cell-mediated cytotoxicity activity. While pertuzumab products alone can inhibit the proliferation of human tumor cells, the combination of trastuzumab and pertuzumab products augments their individual anti-tumor activity.

Disease or Condition

HER2-positive cancer

HER2-positive breast cancer is a type of breast cancer in which the cancer cells have an excessive amount of the HER2 protein on their surface. The exact cause of HER2-positive breast cancer is unknown, but it is believed to be related to a mutation in the HER2 gene. This mutation leads to the production of larger than normal amounts of HER2 protein, which can promote the growth and spread of cancer cells.

Approval Information

A biosimilar is a biological product that is highly similar to, and has no clinically meaningful differences from, a biological product already approved by FDA (also called the reference product). This means patients can expect the same safety and effectiveness from the biosimilar as they would the reference product.

An interchangeable biosimilar is a biosimilar that has met other requirements under the law and may be substituted for the reference product without consulting the prescriber. The substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state, a practice commonly called “pharmacy-level substitution” – similar to how generic drugs are substituted for brand name drugs.

All biological products are approved only after they meet FDA’s rigorous approval standards. This means health care providers and patients can expect the same safety and effectiveness from both a biosimilar and an interchangeable biosimilar, just as they would for a reference product. Biosimilar and interchangeable biosimilar products may cost less than the brand-name medicine (i.e., reference product).

FDA’s approval of Poherdy is based on a comprehensive review of scientific evidence demonstrating the product is highly similar to Perjeta and that there are no clinically meaningful differences between the two products. This evidence included comparisons of the products on an analytical level using an extensive battery of physicochemical tests and biological assays

Multiple lots manufactured for each product were compared across a broad range of different product quality attributes, and the results of these comparisons confirmed similarity in the structural and functional features of Poherdy with Perjeta including those known to impact safety and efficacy. The comparative clinical data to support approval of Poherdy was based on results from a pharmacokinetic (PK) study in healthy adult subjects that confirmed similar exposure between Poherdy and Perjeta following a single intravenous infusion. In addition, a study in patients with early HER2-positive and HR-negative in the neoadjuvant setting was submitted and the results support approving Poherdy as an interchangeable biosimilar. The totality of these data supported FDA approval of Poherdy as an interchangeable biosimilar to Perjeta.

Safety Information for Poherdy

The side effects and adverse events observed in clinical trials of Poherdy are consistent with those observed with Perjeta. The most common adverse reactions with pertuzumab depending on the chemotherapy combination regimen are diarrhea, alopecia, neutropenia, nausea, vomiting, fatigue, rash, peripheral neuropathy, anemia, thrombocytopenia, constipation, mucosal inflammation, and myalgia.

Poherdy, like Perjeta, can also cause serious side effects including left ventricular dysfunction, embryo-fetal toxicity, infusion-related reactions and hypersensitivity reactions/anaphylaxis.

See full prescribing information for additional information on risks associated with Poherdy.