Biosimilars or follow-on biologics are biopharmaceutical drugs that are similar to approved biological drugs. Biosimilars are different from other generic drugs in terms of raw material and their manufacturing process. Generic drugs are composed of small molecules. However, biosimilars are composed of more complex molecules, such as human insulin and monoclonal antibodies. Many biosimilars are derived from plants, animals, bacteria, viruses and yeast. It is produced by recombinant DNA technology and controlled gene expression methods. Biosimilar drugs are used in prevention and treatment of various severe diseases such as cancer, diabetes, autoimmune diseases, heart attacks, rheumatoid arthritis, oncology, growth hormone deficiency, chronic kidney failure, hematological disease and infectious disease. Biosimilars offer less costly treatment than other biological drugs and synthetic drugs.
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Europe is the largest market for biosimilars followed by North America and Asia-pacific. Asia-pacific is the fastest growing market for biosimilars due to low manufacturing cost, availability of skilled labor, less stringent regulatory environment and low manufacturing cost. Moreover, government associations are promoting the usage of biosimilars. For instance, in India, government provides various essential and regulatory guidelines for the usage of biosimilars products. In addition, low costs of biosimilars attract end users to adopt these products over synthetic and biological drugs in the Asian countries.
Globally, biosimilars market is driven by aging population, increasing incidences of diabetes and chronic disorders, government support and initiatives and high cost of biological drugs. Moreover, emerging pharmaceutical market and less stringent government regulatory frameworks provides some of the major opportunities for biosimilars market. In addition, increased collaboration between manufacturing companies and outsourcing of biosimilar products are key trends for biosimilars market. However, some of the major restraints of biosimilars market are high manufacturing cost and complexity and presence of low priced generic drugs.
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Some of the major companies operating in the biosimilars market are Actavis, Inc., Sandoz International GMBH, Teva Pharmaceutical Industries Ltd., Celltrion, Inc., Hospira Inc., Biocon Ltd., Mylan, Inc., Cipla Ltd, Amgen, Inc., Dr. Reddy’s Laboratories Ltd., Stada Arzneimittel Ag and Wockhardt Ltd.
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