Pfizer notches two EU approvals, including Herceptin biosimilar

pharmafile | August 1, 2018 | News story | Research and Development, Sales and Marketing Cancer, EMA, EU, Genetech, Herceptin, Pfizer, Trazimera, Xeljanz, biosimilar, breast cancer, pharma 

Pfizer is patting itself on the back after securing two new approvals in Europe within 24 hours: Xeljanz (tofacitinib citrate) for the treatment of moderately to severely active ulcerative colitis (UC) in adult patients for whom other therapies have proved unsuitable, and its biosimilar Trazimera (trastuzumab) in the treatment of human epidermal growth factor (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

The decision on Xeljanz, which makes it the first and only oral therapy and Janus kinase (JAK) inhibitor available in the aforementioned patient population, followed a positive recommendation from the EMA’s Committee for Human Medicinal Products (CHMP), noting that it provided “significant clinical benefit” in UC compared to existing therapies.

The approval marks the third for the drug in the EU, including the treatment of moderate to severe active rheumatoid arthritis in adults for whom one or more disease-modifying antirheumatic drugs (DMARDs) are unsuitable, and in active psoriatic arthritis in patients for whom a prior DMARD has proven inadequate or intolerable.

“Ulcerative colitis is a chronic disease that can develop at any age, be difficult to manage and affect multiple aspects of daily life,” said Angela Lukin, Regional President, Inflammation and Immunology at Pfizer. “The EC approval of XELJANZ provides an additional treatment option that can help improve the care of adults in Europe living with this debilitating inflammatory bowel disease.”

Like Xeljanz, Trazimera was also recommended by the CHMP back in May. The approval decision was based on “comprehensive” evidence which proved the drug’s non-inferiority to its reference product, Genentech’s Herceptin.  

“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,” explained Professor Diana Lüftner, Charité Campus Benjamin Franklin and Member of the Presidency of the German Society of Hematology and Medical Oncology. “Today’s approval will help enable greater access for patients and physicians across Europe, without compromising on quality, efficacy and safety.”

Richard Blackburn, Global President, Pfizer Essential Health Europe, Africa/Middle East and Biosimilars, also added: “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. Pfizer is investing in developing and launching a range of biosimilars which can help to reduce healthcare costs and increase patient access to important medicines.”

Matt Fellows

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