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Biosimilars are intended to be lower cost, high-quality treatment options that have the potential to alleviate such burden. We sincerely hope our trastuzumab biosimilar will do exactly that,” said Sang-Jin Pak, Senior Vice President and Head of Commercial Division, Samsung Bioepis.
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In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab products in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence
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face an existential threat," he said Friday. It will be game over for these products until they can successfully traverse the regulatory process," Gottlieb warned. The FDA has the authority to block e-cigarette sales and force makers to go through the formal FDA approval process, but has not done
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