Gottlieb added that the FDA is "committed to taking new policy steps to advance our biosimilar pathway and promote more competition for biological drugs".
Mylan and Biocon's biosimilar is called Ogivri (trastuzumab-dkst) and follows a back and forth of delays with regulators over manufacturing issues at a plant in India.
Mylan has become the first pharma company to win United States approval for a biosimilar of Roche's big-selling cancer antibody Herceptin.Читайте также: Today's Google Doodle created to teach kids how to code
This is the first US/EU biosimilar approval for the partnership, allaying concerns over compliance with manufacturing standards, potentially paving the way for Biocon's biosimiliar of chemotherapy drug Neulasta in Q1 2018, according to Kotak Securities analysts.
Ogivri's clearance is based on a review of evidence that included extensive structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates its biosimilarity to Herceptin (trastuzumab).
Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon's joint portfolio approved in the US.
"The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the USA healthcare system", said Mylan's chief executive Mylan chief executive Heather Bresch. Herceptin had USA sales of more than $2 billion in the year ended September, according to global healthcare information provider IQVIA.При любом использовании материалов сайта и дочерних проектов, гиперссылка на обязательна.
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