Trastuzumab and Adalimumab Biosimilars Receive Positive CHMP Opinions

Two biosimilar developers today announced that they have received positive opinions for products from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

Pfizer announced a positive opinion for its first European anticancer biosimilar, a trastuzumab product that the company plans to sell as Trazimera.

“Pfizer is extremely proud to offer expanded biologic treatment options for patients by bringing more affordable, life-changing biosimilar medicines to market, and today’s positive recommendation from the CHMP marks one more step forward,” said Amrit Ray, MD, MBA, global president of research and development for Pfizer Essential Health, in a statement.

As part of its data package on the drug, Pfizer submitted data from the phase 3 REFLECTIONS B327-02 study, results of which were presented at the European Society for Medical Oncology’s 2017 conference. The study demonstrated that the biosimilar had similar efficacy, safety, and immunogenicity to the reference trastuzumab in patients with HER2-positive early breast cancer.

The CHMP opinion comes as positive news for Pfizer after the same product received a Complete Response Letter from the FDA in April 2018; Pfizer indicated that the FDA had discussed the need for “additional technical information” on the product, but that it did not seek further information related to safety or clinical data.

On the same day, Sandoz announced a positive CHMP opinion for its adalimumab biosimilar, GP2017. In a statement, Richard Francis, CEO of Sandoz, called the development “an important milestone for the millions of patients looking to reclaim their health after an autoimmune disease diagnosis.” Sandoz plans to market the drug under the names Halimatoz, Hefiya, and Hyrimoz.

Sandoz submitted a data package for the product that included findings from the phase 3 ADACCESS study in patients with moderate to severe plaque psoriasis. Results of the study, which were presented at the American Academy of Dermatology Annual Meeting in March 2017, demonstrated that the biosimilar had similar efficacy to the reference Humira; after 16 weeks of treatment, 67% of patients receiving the biosimilar achieved a 75% improvement in their symptoms (as measured by the Psoriasis Area Severity Index) versus 65% of those treated with the reference product. The biosimilar’s safety profile was also similar to that of the reference.

GP2017 has also been submitted to the FDA for US regulatory review.

Both Pfizer’s Trazimera and Sandoz’s adalimumab will now be reviewed by the European Commission (EC); if the EC ultimately approves the products, it will grant centralized marketing authorizations that will be valid in EU member states. Norway, Iceland, and Liechtenstein, members of the European Economic Area, will follow corresponding decisions based on the EC’s decision.