IMMUNOLOGY
Aenorasis is building on the heritage of solid partnerships and delivering first-in-class and best-in-class therapies to improve the quality of life of people living with autoimmune diseases.
“Biologics” represent one of the fastest growing segments of the pharmaceutical industry.They refer broadly to substances produced by living cells using biotechnology (ie, recombinant DNA technology, controlled gene expression, or antibody technologies),which have introduced many new treatments to life-threatening and rare illnesses such as cancer, diabetes, anemia, rheumatoid arthritis and multiple sclerosis.They involve a wide range of substances, including recombinant hormones, growth factors, blood products, monoclonal antibody-based products, recombinant vaccines, and advanced technology products (gene and cell therapy biological products). 1 Sekhon and Saluja Biosimilars 2011:1
Biopharmaceuticals have potential to reach up to 50% share in global pharmaceutical market in the next few years. [1] The expiry of patent protection of many biopharmaceuticals has initiated the development of a category of alternative versions of innovator biopharmaceuticals known as biosimilars. Because of the structural and manufacturing complexities, these biological products are considered as similar, but not generic equivalents of innovator biopharmaceuticals. The term “biosimilar” is in common use in the European Union, while the term “follow on biologics” is more popular in the American context.
What are Biosimilar medicines
Τhe European Medicines Agency
A biosimilar is a biological medicinal product that contains a version of the active substance of an already authorized original biological medicinal product (reference medicinal product). A biosimilar demonstrates similarity to the reference product in terms of quality charasteristics, biological activity, safety and efficacy base on a comprehensive comparability exercise 2
Mark McCamish1 and Gillian Woollett2,* mAbs 3:2, 209-217; March/April 2011;
The importance of biosimilar medicines
Biosimilar medicines offer physicians an affordable and therapeutically equivalent alternative to essential but expensive reference products. This means that more patients can be treated with the same budget , or that savings can be made in order to fund other treatments.
1.Nowicki M. Basic facts about Biosimilars. Kidney Blood Press Res 2007;30:267-72
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