Development and Commercialization of Biosimilars in India: Current Regulatory and Clinical Experience
The ever-increasing cost of healthcare together with our improved understanding of biotech therapeutic drugs has fueled the rise of biosimilars. A step towards achieving the successful development of a biosimilar is to establish analytical similarity with the innovator drug. This is necessary so as to avail the significant reduction in clinical data required for achieving regulatory approval. A key concern is the limited understanding of how the different quality attributes (QA) affect its safety and efficacy profile. India has successfully demonstrated its ability to make affordable, high-quality pharmaceutical products for the world, particularly the small molecule generics. This fact is validated by the trend that the share of Indian made pharmaceutical products in the US market has been constantly increasing and is presently more than 30%. The question is if India can successfully replicate its success, in manufacturing complex biotherapeutic products. This chapter explores India’s journey in the field of biosimilar manufacturing with an emphasis on the regulatory aspect. Followed by a concise overview of the evolution of global regulatory guidelines, the Indian framework has been discussed in detail. Major changes introduced in the latest guidelines for similar biologics (2016) have been highlighted. Insight into the key developments related to clinical experiences and thereby addition of more sophisticated platforms to the analytical armory in the past decade for characterization of biosimilars has been given. Two recently published case studies on analytical platform approach used to establish similarity for microbial (GCSF) and mammalian product (Rituximab), in the Indian marketplace, using an array of advanced, orthogonal, high-resolution analytical methods, have been discussed. Finally, the importance post-approval pharmacovigilance as a feedback mechanism to update and improve existing regulatory framework has been outlined.
KeywordsAffordable biopharmaceutical Analytical comparability Biosimilar market Clinical experience Regulatory framework Revised guidelines Similar biologics
This work was funded by the DBT Centre of Excellence for Biopharmaceutical Technology grant under Department of Biotechnology, Government of India (BT/COE/34/SP15097/2015).
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