Pfizer: EU green light for Herceptin biosimilar, looks to US

By Flora Southey contact

- Last updated on GMT

(Image: Getty/Talaj)
(Image: Getty/Talaj)
The European Commission has approved Pfizer’s Trazimera, a biosimilar version of Roche’s best-selling oncology monoclonal antibody, Herceptin.

Trazimera (trastuzumab) is indicated for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

The approval follows the European Medicines Agency’s (EMA) recommendation​ for marketing authorisation to the European Commission, in May this year.

While a Pfizer spokesperson declined to comment on specific pricing or commercialisation strategies for Trazimera, the firm hopes the introduction of biosimilars to the European market will improve access to potentially lower-cost alternative treatments.

The spokesperson was similarly tight-lipped about Pfizer’s biosimilar strategy going forward, but confirmed the company has a pipeline of nine distinct molecules in various stages of development.

Trazimera is Pfizer’s first biosimilar in oncology to receive EU approval, and joins the company’s versions of J&J’s Remicade (infliximab), Amgen’s Neulasta (filgrastim), and Amgen’s Epogen (epoetin zeta) in Europe.

Eyes on US

In April this year, the US Food and Drug Administration (FDA) rejected​ Pfizer’s proposed trastuzumab biosimilar in a complete response letter (CRL).

However, according to Pfizer, the firm plans to resubmit a biologics license application to the FDA.

“We remain committed to bringing this important medicine to patients in the US and are working diligently in close collaboration with the FDA to address the items outlined in the CRL,” ​the spokesperson told us.

 

Related topics: Markets & Regulations, Biosimilars

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