BIOSIMILAR: AN OVERVIEW
AbstractBiosimilars are defined as officially approved new version of innovator bio-therapeutic products for which the patent has expired. Biosimilars the ‘generic’ versions of biopharmaceuticals, continue to enter Indian pharmaceutical market, to treat a variety of diseases. Biosimilars available in India include monoclonal antibodies for treating various malignant and immunological disorders, growth factors like erythropoietin and granulocyte colony stimulating factor (G-CSF), human insulins for treating diabetes mellitus etc. In the recent scenario, there is an increasing demand for biological drugs. The development and production of biosimilars are boosted by existing manufacturing technology. Due to no investment in phase I-II of clinical trials, biosimilars are available at cheaper prices than the reference products, so that it has low market risk. The main goal of this review is that the phase I-II trials are typically not required for biosimilar approval unless it is found necessary in special cases. Phase III trials with a minimum of 100 patients are mandatory for establishing bioequivalence. Therefore, the total cost to develop a biosimilar in India can range from $10 – 20 million, which helps Indian companies to offer their products at a 25-40% cheaper price than the innovator biologics.
Article Information
11
2132-2144
563KB
2668
English
IJPSR
Sagar J. Kanase*, Yogesh N. Gavhane, Ashok Khandekar, Atul S. Gurav and A.V. Yadav
Department of Biopharmaceutics, Government College of Pharmacy, Karad- 415 124, Maharashtra, India
sagarkanse77@gmail.com
30 January, 2013
30 January, 2013
12 May, 2013
http://dx.doi.org/10.13040/IJPSR.0975-8232.4(6).2132-44
01 June, 2013
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