NEHA MISHRA, S. YADAV
ABSTRACT
Biosimilars or “Follow-on-Biologic†defined as biologic medicinal products comparable in quality safety and efficacy to reference products, follow the independent regulatory pathway in the EU for marketing authorizations after the patent expirations of the reference products. Also these are similar to, but not the same as, innovator biologics which are vastly more complex than traditional pharmaceuticals and are produced through biological processes that generally involve recombinant DNA technologies. These are manufactured in a living system such as a microorganism, or plant or animal cells and mostly are very large, complex molecules or mixtures of molecules and hence they are typically injected and interact within the body in the bloodstream or on the surfaces of cells, rather than within the cells. Few examples of approved biosimilar drugs are Enbrel, Rituxan, Humira, Avastin, Gleevac. Biosimilars are only similar in composition to a reference product, but may not be identical or even interchangeable whereas, generic drugs are required to be identical in safety, efficacy, dose, and administration to the brand name counterpart. These drugs are the protein products and include recombinant DNA technology, monoclonal antibodies, and gene therapy revolutionizing treatment of diseases and complex conditions. Biosimilar drugs make up 10 to 15% of the pharmaceutical market in the United States, and this sector is growing faster than any other class of drugs, but it should also provide cost savings and greater accessibility to biopharmaceuticals.
KEYWORDS: Biological, biopharmaceutical, biosimilar, generic, biogeneric.