EMA recommends Pfizer’s Herceptin biosimilar, EU Commission to assess

By Flora Southey contact

- Last updated on GMT

(Image: Getty/yganko)
(Image: Getty/yganko)
The EMA has recommended approval of Pfizer’s Trazimera, a biosimilar version of Roche’s best-selling monoclonal antibody, Herceptin (trastuzumab).

The European Medicines Agency (EMA) committee for medicinal products for human use (CHMP) has recommended marketing authorisation of Pfizer’s Trazimera to the European Commission (EC).

Trazimera is designed to treat HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

Pfizer did not disclose its specific pricing strategies for Trazimera, but a spokesperson told us the biosimilar could offer a lower-cost option for some cancer patients.

“By introducing biosimilars like Trazimera to the European market, Pfizer hopes that patients and their physicians will have improved access to a high-quality, potentially lower-cost alternative treatment option for the treatment of HER2 overexpressing breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma.”

The EC will review the CHMP’s positive opinion before deciding whether to grant Pfizer marketing authorization.

“Whilst the EC generally adheres to the recommendation of the CHMP, Pfizer cannot speculate on the outcome and expects a final decision will be delivered in next several months,” ​the spokesperson told us.

If approved, Trazimera will become the third biosimilar version of Roche’s Herceptin in Europe.

In November 2017​, Samsung Bioepis received EU approval for its Herceptin biosimilar, Ontruzant, to be sold by MSD (known as Merck & Co. in North America). In March this year​, Celltrion’s version of Herceptin, Herzuma, received EU approval.

MundiPharma has secured the rights to launch Herzuma in seven countries: Germany, UK, Ireland, Belgium, the Netherlands, Italy and Luxembourg.

Pfizer has also filed regulatory applications for Trazimera in other geographies, including in the US. Though last month, we reported​ the US Food and Drug Administration (FDA) had vetoed its proposed Herceptin biosimilar, PF-05280014, in a complete response letter (CRL).

According to Pfizer, the rejection did not relate to safety or clinical data concerns. “In the CRL, the FDA highlighted the need for additional technical information,” ​a spokesperson told us at the time.

Related topics: Markets & Regulations, Biosimilars

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