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    Trends in Biosimilars: Innovative Approaches to Expediting Development

    This article discusses innovative approaches to expediting biosimilar drug development. As sponsors of biosimilars seek additional efficiencies to get to the market more quickly, it behooves regulatory professionals to become aware of the different tactics and options that biosimilar drug developers can employ to bring copies of expensive biologics to the global market not only more quickly, but more broadly and less expensively. Introduction The biosimilars market cont...
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    Strategies Adopted by Innovator Companies in Response to Biosimilars Competition

    This article examines key strategies being adopted by the innovator companies and discusses the impact these strategies are likely to have on the future market for biosimilars. Introduction Over the last 25 years, biologic medicines have transformed how several chronic and life-threatening diseases are treated. Because of the great value of these innovative biologic medicines and the capital required to bring them to market, they are able to command high prices. For e...
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    Lessons Learned from Biosimilar Drug Development

    This article discusses the emerging US biosimilars market, including critical success factors, safety issues, extrapolation, choice of reference product, partnerships and alliance management, clinical trial recruitment and regulatory and commercial factors. It also describes an accelerated approach to biosimilar clinical development. Introduction The US biosimilars market is at an interesting juncture, with one product launched (Sandoz's filgrastim biosimilar, Zarxio)...
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    Early Biosimilar Development: A Model for Expeditious Progress to a Phase 3 Trial

    This article discusses biosimilar clinical development and how companies are addressing the clinical development concerns associated with early biosimilar drug development. Introduction The introduction of biological medicines has had a significant impact on the health of patients suffering from many debilitating and life threatening diseases. Biological medicines have dramatically reduced disability for patients with inflammatory diseases, such as rheumatoid arthriti...
  • Safety Concerns Related to Global Biosimilars Drug Development

    An initial unfortunate experience in the late 1990s served as an alert to the inherent risks of making apparently small changes to a biological product. The changes by the manufacturer to the formulation of erythropoietin, marketed as Eprex (epoetin alpha), resulted indirectly in the induction of an immune response, which manifested as a dramatic increase in the frequency of cases of pure red cell aplasia, 1 requiring some patients to have blood transfusions and dialysis...