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The majority of the 10 top-selling drugs in 2017 were biologics, each exceeding sales of US$5 billion. Since their introduction, they have provided treatment options for people who suffer from some of the most serious medical conditions, such as cancer and genetic disorders. With the patents and other intellectual property rights for originator biologics set to expire over the next decade, biosimilars are expected to enter the market and increase industry competition.
Regulatory agencies, such as the FDA, EMA, and Health Canada, support the integration of biosimilars into the market, and have developed guidelines for the evaluation and approval processes of these drugs. With 6 biosimilars reaching the market in recent years, interchangeability with the reference product has become a hot topic as more and more companies are seeking interchangeability designations for their products. As a result, the FDA released its long-awaited draft guidance recommending that sponsors conduct one or more studies to compare the safety and efficacy of the reference product and the biosimilar.
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Altasciences understands the development and conduct of cost-effective, customized biosimilar clinical pharmacology studies, and the importance of minimizing bioanalytical and recruitment challenges to facilitate market entry after patent expiration. Identifying study challenges early on can ensure a successful early phase biosimilar development program. Our experts are available 24/7 to answer your questions, and help get your study started.
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