Biosimilars and regulatory authorities.
ABSTRACT The patent expirations for many biotechnological medicines have prompted the development of copies of biological medicinal products. Unlike generics, biosimilars are similar but not identical to their reference product, because their chemical characteristics are directly related to the manufacturing process which cannot be precisely duplicated. The regulatory policy for biosimilars is complex and in Europe it is regulated mainly by guidelines issued by the European Medicines Agency (EMEA); additional product-class specific guidelines have been developed as in the case of recombinant human erythropoietin (rHuEPO). In 2008, the experience gained with this drug has prompted the development of a new guideline, currently in draft. In this review we critically discuss aspects related to EMEA guidelines, particularly focusing on rHuEPO.
- SourceAvailable from: Isabelle Lepage-NefkensThe European Journal of Health Economics 11/2013; 15(3). DOI:10.1007/s10198-013-0538-4 · 2.10 Impact Factor
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ABSTRACT: Biologics play an integral role in the treatment of cancer not only for their therapeutic effects and ability to improve outcomes, but also as supportive care agents. Biologics are more complex to manufacture and take longer to bring to market. Because biologics are considerably more costly than small-molecule drugs, their use has placed an increasing economic demand on healthcare systems worldwide. Biosimilars are designed to be highly similar to existing branded biologics, but because biologics cannot be exactly copied, biosimilars should not be referred to as generic, exact versions of the innovator biologic. Biosimilars have the potential to increase access and provide lower cost options for cancer care as patent protection for some of the most widely used biologics begins to expire. Regulatory requirements for biosimilars are evolving, as are global harmonization and/or standardization strategies that can facilitate their robust clinical development. This review highlights critical factors involved with the integration of biosimilars into oncology treatment paradigms and practices. Clinicians will likely seek out practice guidelines and position statements from established scientific societies to help evaluate key information regarding biosimilars, such as efficacy, safety, comparability, and interchangeability with the reference biologic. Automatic substitution, nomenclature, extrapolation of clinical data from one indication to another, as well as parameters for ongoing pharmacovigilance are evolving considerations. Education of physicians and other healthcare providers, payers, and patients about biosimilars may facilitate informed decision making, promote acceptance of biosimilars into clinical practice, increase accessibility, and expedite associated health and economic benefits.Seminars in Oncology 04/2014; 41 Suppl 3:S3-S12. DOI:10.1053/j.seminoncol.2014.03.008 · 3.94 Impact Factor
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ABSTRACT: With the emergence of biosimilars as a new class of biotherapeutic agents, the use of these products in Latin America has become a focus of attention. To aid policymakers and regulatory authorities, a group of experts on biosimilars developed a series of recommendations for the regulation of biosimilars and their implementation in the region. Although most of the Latin American countries have adopted, in general, the WHO recommendations; there are some of them whose regulations diff er from WHO. Unfortunately, the pace at which the region moves toward reaching its potential of having safe and eff ective biosimilars has been slow. Countries in the region must enhance their eff orts to improve pharmacovigilance to include training more regulatory staff , more public and professional awareness on the importance of reporting adverse events and better systems to capture and analyze data. Regulatory authorities should also establish a process whereby the traceability of an adverse event to a biosimilar can be determined. Products previously approved as ‘intended copy’ drugs should be evaluated according to regulations specifi c to biosimilars. It cannot be assumed that a previously approved biopharmaceutical is actually a biosimilar, regardless of current clinical experience. Latin America is no exception to the slower-than-expected pace of developing regulations on biosimilars. The panel’s perspectives on the current status led to six major recommendations in order to enhance the safe use of biosimilars in the region.06/2014; 3(3):1. DOI:10.5639/gabij.2014.0303.032