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  • Feature ArticlesFeature Articles

    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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    Biosimilar Intellectual Property Issues in the US: An Update

    This article provides an update on US biosimilar intellectual property issues in areas including the complex and evolving areas of patent protection, market exclusivity, the 'patent dance,' and lifecycle planning. 1 Introduction Biological medicines are comprised of large, complex molecules produced by living organisms. Biological medicines are used for disease prevention or treatment and their entry into clinical practice has revolutionized healthcare in many c...
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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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    Filling a Regulatory Void: Patient Advocates Submit Guidance for Duchenne Muscular Dystrophy

    Muscular dystrophy (MD)––a group of diseases that cause progressive muscle weakness due to defects in muscle proteins ––has a range of complex features that make treatments elusive. MD exists in many forms (Duchenne MD is the most common); animal models do not accurately reflect human disease; and it is difficult to define and measure the progression of this slow disease. Because MD can be life-threatening, new disease-modifying (serving to slow or halt progression) an...
  • 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...
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    Muscular Dystrophy Treatments: European and US Regulatory Study Landscapes

    The proteins and structures of certain diseases associated with muscular dystrophy (MD) are beginning to be elucidated by scientists based on recent advances in our understanding of genetics. MD is a group of muscle diseases that clinically manifest in patients as progressive muscle weakness with associated loss of mobility, agility and body movements due to defects in muscle proteins that result in the death of muscle cells and tissue . With these scientific adva...