A Study on BioBetters: Various Aspects and Regulatory Approval Process
Lakshmi Prasanthi Nori1, Aditya Nidumolu1, Terli Ragdeep1, Vyasam Vishnu Vardhan1, K. Venkateswara Raju1★★ Corresponding author
- 1Department of Regulatory Affairs, Shri Vishnu College of Pharmacy, Bhimavaram, Andhra Pradesh, INDIA.
CORRESPONDENCE
K. Venkateswara Raju
Department of Regulatory Affairs, Shri Vishnu College of Pharmacy, Bhimavaram, Andhra Pradesh, INDIA.
Received: 17-06-2023; Revised: 29-06-2023; Accepted: 20-07-2023.
Volume 13, Issue 4 · pp. 703–710 · PUBLISHED · DOI: 10.5530/ijpi.13.4.088
ABSTRACT
A new class of biopharmaceuticals are developed by changing profile in terms of chemistry structure and functionality resulting in enhanced efficacy in terms of reduction in immunogenicity toxicity and improvement in half-life and pharmacodynamic activity. The term "BioBetter" refers to a form of biologic that has been enhanced for safety, and patient compliance while lowering the overall cost of healthcare. Despite the fact that BioBetters generally have advantages, they will still face a number of challenges, including high costs for clinical trials, regulatory approval, patent disputes, and market opportunities. Therefore, the development of BioBetter necessitates striking a careful balance between improving patient medical management without sacrificing innovation for corporate success. Two approaches are followed to develop BioBetters Changes in formulation and engineering the protein molecule. In this article we provided a brief overview of a better development like recombinant fusion, antibody engineering and PEGylation.
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Nori, L. P., Nidumolu, A., Ragdeep, T., Vardhan, V. V., & Raju, K. V. (). A Study on BioBetters: Various Aspects and Regulatory Approval Process. International Journal of Pharmaceutical Investigation, 13(4), 703–710. https://doi.org/10.5530/ijpi.13.4.088