CHMP recommends approval of biosimilar Trazimera for treatment of stomach cancer or gastroesophageal coesophageal adenocarcinoma
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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, u.SPharmaceuticals(PFizer) announced that the EuropeanPharmaceutical(EMA) forMedicines
(CHMP) has issued a positive opinion recommending the approval of biosimilar Trazimera for her2-positive breast cancer and HER2-positive metastatic stomach cancer or esophageal cob disease treatmentabout TrazimeraTrazimera does the brand drug for Roche's heavyweight product Herceptin (Hercetin, generic name: Trastuzumab, Qutobea monofight)Trazimera is Pfizer's first generic drug for cancer students under review in the EUROPEAN Union, and the European Commission (EC) is expected to make a final review decision in the next 2-3 monthsapproved, Trazimera is expected to provide patients with a more affordable treatment option that will help address the evolving needs ofmedical(systems, doctors, taxpayers, and patients)related studiesthe submission of the Trazimera regulatory document, based on a comprehensive package and overall evidence that the product is highly similar to the original drug Herceptin, including a comparative results from the REFLECTIONS B327-02 clinical study, confirming that two products have clinical equivalence for the first-line treatment of HER2-positive metastatic breast cancer, with no clinical differencesas part of the REFLECTIONS clinical program, Trazimera has studied nearly 500 patients in more than 20 countries worldwide to dateTrazimera is Pfizer's fourth biosimilar and the first tumor student genericThecompany(there are currently 11 different biosimilars in the biosimilar pipeline at different stages of development)
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