Biosimilar Drugs
Journal Title: Journal of Clinical and Analytical Medicine - Year 2012, Vol 3, Issue 2
Abstract
Biotechnological (biopharmaceutical) products are complex macromolecules created through the genetic manipulation of living organisms using recombinant DNA technology, monocolonal antibodies and gene therapy. The patent expirations for many biotechnological medicines have prompted the development of copies of biological medicinal products. These new biotechnology medicines are known as “biosimilars”. Due to the complex method of production of biological medicines, biosimilar medicines are only similar in composition to a reference product, but may not be identical. Comparative quality, pre-clinical and clinical studies have to be provided by the biosimilar manufacturer to substantiate the similarity of structure/composition, quality, safety and efficacy between the new biosimilar and the chosen reference medicinal product. With a suitable regulatory process, biosimilars have the potential to provide considerable cost savings to both patients and healthcare providers. But, a comprehensive understanding of new products, including manufacturing process, prescribing habits, marketing practices, patent terms, and clinical use needs to be addressed with regulatory authorities, scientists and pharmaceutical industry before the future of biosimilars becomes a reality.
Authors and Affiliations
Muradiye Nacak, Zafer Sezer, Aydın Erenmemişoğlu
Keywords
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