Mini Review
Commercializing Biosimilar: Challenges, Strategies and Finding Path to Success
Prashant A Pandya*
Department of Program Management, Clinical Development, Navi Mumbai, India
- *Corresponding Author:
- Prashant A Pandya
Department of Program Management
Clinical Development, Navi Mumbai, India
Tel: +91-9967017172
E-mail: drpandya18@gmail.com
Received Date: August 02, 2017; Accepted Date: August 12, 2017; Published Date: August 21, 2017
Citation: Pandya PA (2017) Commercializing Biosimilar: Challenges, Strategies and Finding Path to Success. Clin Pharmacol Biopharm 6:173. doi: 10.4172/2167-065X.1000173
Copyright: © 2017 Pandya PA. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use,distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
Biosimilars and reference biologics have the same amino acid sequences. Differences in clinically inactive components are generally quite minor. Developments of Bio similar involve a series of complex decision and anyone of which have significant impact on Organization success. Early risk identification allows companies to put preventive measures in place to save development time and maximize return on investment. There are numerous development and regulatory constraints associated with biosimilar development affecting decision of commercialization. It is important to optimize commercialization strategies as regulations are still evolving hence it is vital for the companies to quickly modify biosimilar development strategies matching with the regulatory scenario.