Perspective, perceptions, and promulgation of biosimilars: A questionnaire-based study to assess and understand the current challenges of biosimilars to the potential and intended users
Krishan Kumar Bhardwaj1, K Bangarurajan2, Tanveer Naved3, Satyendra Kumar Rajput4
1 Central Drugs Standard Control Organization, Ghaziabad, Uttar Pradesh, India; Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh, India
2 Central Drugs Standard Control Organization, New Delhi, India
3 Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh, India
4 Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh, India; Amity Institute of Indian System of Medicines, Amity University, Noida, Uttar Pradesh, India
Mr. Krishan Kumar Bhardwaj
O/o of DDC (I), CGO Complex No-1, Central Drugs Standard Control Organization, North Zone, Ghaziabad.
Source of Support: None, Conflict of Interest: None
Introduction: Biosimiliar, a copy of reference biological product, is making a buzz across the globe for its upper edge therapeutic usage. According to the market research report published by P&S Intelligence, biosimilars market is expected to generate $26.7 billion revenue by 2024, advancing at a CAGR of 29.6% during the forecast period. The first biosimilar to medicine Omnitrope, was approved in Europe by EMA (European Medicines Agency) in year 2006. Till date countries like US, China, Japan, India and many more have generated regulatory guidelines for biosimilars. Aim: Current study addresses the issues and challenges faced by Industry and regulators with their potential solutions and recommendations. Materials and methods: The questionnaire having 21 important questions/comments was given to participants after explaining the purpose of the study. The response in terms of responders V/s non-responders, agree V/s disagree, yes V/s no was recorded and analyzed by descriptive statistics. Results and Discussion: The study shows the limitation regarding the qualified personnel involved in biosimilars, as approx. 91% people believe that there is lack of expertise in this field. The same can be achieved through government initiatives for bridge courses which is also strongly felt by the major (83.6%) stakeholders participated in the study.