Pfizer wins Herceptin biosimilar approval in Europe

European Commission (EC) has approved Pfizer’s Trazimera, for breast and gastric cancer treatment, marking it as pharma’s first oncology biosimilar to receive approval in the EU.

It is the fourth Pfizer biosimilar to receive the green light for use in the EU and the company reoprts having at least nine more in various stages of development.

Richard Blackburn, global president, Pfizer Essential Health Europe, Africa/Middle East and Biosimilars, said: “The approval of Trazimera, Pfizer’s first oncology biosimilar, is another significant step in our quest to introduce more treatment options for patients in Europe. We are investing in developing and launching a range of biosimilars which can help to reduce healthcare costs and increase patient access to important medicines.”

Today’s approval allows the drug to be marketed in the 28 member states of the European Union as well as in the European Economic Area.

The biosimilar has been approved to treat HER2-positive breast cancer, metastatic gastric cancer, and gastroesophageal junction adenocarcinoma, the same indications as its reference product.

[caption id="attachment_45195" align="alignleft" width="63"] Diana Lüftner[/caption]

Diana Lüftner, Charité Campus Benjamin Franklin and Member of the Presidency of the German Society of Haematology and Medical Oncology, said: “Trazimera has the potential to help many patients with HER2 overexpressing cancers, such as breast and gastric, which can correlate with poor outcomes and aggressive disease.”

“Today’s approval will help enable greater access for patients and physicians across Europe, without compromising on quality, efficacy and safety.”

The approval follows a positive opinion issued last month by the Committee for Medicinal Products for Human Use (CHMP), which relied on data extracted from Pfizer’s phase 3 REFLECTIONS study.

CHMP found that Pfizer’s Herceptin biosimilar was similar to EU-licensed trastuzumab in terms of efficacy, safety, immunogenicity, and pharmacokinetics when used as first-line treatment.

Pfizer is hopeful for a similar level of success in the US, but has some hurdles to overcome with the FDA first. Earlier this year the company received a complete response letter from the US regulator in response to the same molecule approval request, highlighting the need for “additional technical information”.

Pfizer indicated that it will work closely with the FDA to address the letter’s contents and that it remains committed to developing the product in the US market.