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Traditionally, Medical Affairs has focused on cross-functional collaboration with commercial and R&D teams, medical communication, evidence generation, and dissemination. 1 And, on average , the FDA approved 60% more drugs between 2010-2019 than the yearly average over the previous decade.
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When the first biosimilars were approved by the FDA almost a decade ago, they were expected to provide a cost-effective alternative to expensive biologics, improve accessibility for patients and reduce healthcare spending by creating competition in the biologic market. So, that’s quite the hurdle for access, I think.
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