Herceptin Biosimilar Gets Positive Opinion in Europe

CHMP recommends approval of a new biosimilar to Roche's Herceptin (trastuzumab).

HER2 (human epidermal growth factor receptor 2) breast cancers – approximately 25% of cases – are complicated by over-production of HER2 protein receptors on breast cells, which make the cells grow and divide uncontrollably. As a result, this form of breast cancer often grows faster and is more likely to spread than other breast cancers; it is also more likely to return.

Roche’s monoclonal antibody treatment Herceptin (trastuzumab), an immune targeted therapy, was developed specifically to treat HER2 positive breast cancer. It binds to the HER2 receptors on the surfaces of breast cancer cells, blocking them from receiving chemical growth signals and slowing or halting the growth of the cancer.

HER2-2 positive breast cancer patients in the US were given access to a less expensive biosimilar from Mylan and Biocon when the Food and Drug Administration approved Ogiviri in 2017. The companies have also gained regulatory approval in many other countries around the world.

Soon doctors in the EU will likely be able to prescribe Ogiviri to patients with HER2 positive early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC) as well. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Ogivri, the Marketing Authorization Application from Mylan and Biocon included data that demonstrated no clinically meaningful differences in quality, potency, safety, efficacy and immunogenicity between Ogiviri and Herceptin. The European Commission is expected to make its decision on approval by the end of 2018.


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