Volume : 11, Issue : 11, November – 2024
Title:
PROJECT MANAGEMENT STRATEGIES INVOLVED IN THE DEVELOPMENT OF BIOSIMILAR AND THEIR REGULATORY APPROVAL PROCESS IN US
Authors :
N V GUNASEKHAR*, M. V. NAGABHUSHANAM, G RAMAKRISHNA
Abstract :
Biologics have more complex production processes compared to small-molecule drugs. They may even prove labile when drifting from batch-to-batch or in different production locations. The development of new similar biological product was regulated early to face the relevant challenges of this industry. As a result, since 2006 biosimilars were introduced to biotechnology arena with a massive competition in pharmaceutical industry. In this review, the aspects related to similarity testing of biosimilars to the original biological products are discussed involving manufacturing challenges to ensure the quality, safety, and efficacy of these products to the patient health. Immunogenicity studies are highlighted as an important part of the safety assessments. Additionally, several analytical methods that are usually used to evaluate biosimilars in comparison to their reference biologic are summarized and categorized in terms of the intended physicochemical and biological characterization. On the other hand, the international efforts of several regulatory agencies including the European Medicines Agency, World Health Organization and United States Food and Drug Administration for biosimilar development are discussed according to updated revised guidelines.
Keywords: Biologics, Biosimilars, Approval Process in US
Cite This Article:
Please cite this article in press N V Gunasekhar et al Project Management Strategies Involved In The Development Of Biosimilar And Their Regulatory Approval Process In Us.,Indo Am. J. P. Sci, 2024; 11 (11).
Number of Downloads : 10
References:
1. Guidelines, Biosimilars in the EU, Information guide for healthcareprofessionals, European medicines agency.
2. Considerations in Demonstrating Interchangeability With a Refer-ence Product Guidance for Industry, U.S. Department of Health andHuman Services, Jan 2017.
3. Raymond Donninger, Analysis of characterization of biosimilarsversus new biologic entities (NBEs), BioPharm International 25(10).
4. Pandya PA (2017) Managing Pharmaceuticals and Life SciencesProjects on a Global Scale: A Project Management Perspective. JBioanal Biomed 9: 169-172. doi: 10.4172/1948-593X.1000173
5. Knezevic I, Griffiths E, (2011) Biosimilars — Global issues, nationalsolutions, Biologicals 39(5): 252-255.
6. Gravel P, Naik A, Le Cotonnec J.Y (2012) BiosimilarrhG-CSFs: Howsimilar are they? Target Oncol, 7 pp 3-16 .
7. Prashant Pandya (2017) “Managing Complex R&D Projects- Strate-gies from Project Management Perspectives”. Chronicles of Pharma-ceutical Science 1(3): 113-117.
8. Pombo ML, Di Fabio JL, Cortés Mde L (2009) Cortes Review ofregulation of biological and biotechnological products in LatinAmerican and Caribbean countries, Biologicals, 37 (5): 271-276 .
9. Minghetti P, Rocco P, Cilurzo F, Vecchio LD, Locatelli F,et al (2012) Theregulatory framework of biosimilars in theEuropean Union. DrugDiscovery Today 17(1-2): 63–70.
10. Kay J (2011) Biosimilars: a regulatory perspective from America.Arthritis Research & Therapy 13(3): 112
11. Rotenstein, LS, Ran N, Shivers JP, Yarchoan M, Close KL, et al (2012)Opportunities and Challenges for Biosimilars.
12. Brahmaiah Bonthagarala, Regulatory Requirements for Registration of Generic Drugs in “BRICS” Countries, International Journal of Pharmaceutical Science and Health Care, ISSN 2249 – 5738, Issue 6, Vol. 6 (November-December 2016), 20-39.
13. Brahmaiah Bonthagarala,Current Regulatory Requirements for Registration of Medicines, Compilation and Submission of Dossier in Australian Therapeutic Goods Administration, International Journal of Advanced Scientific and Technical Research, ISSN 2249-9954, Issue 6 volume 6, November-December 2016, 144-157.
14. Brahmaiah Bonthagarala,Comparison of Regulatory Requirements for Generic Drugs Dossier Submission in United States and Canada, International Journal of Pharmaceutical Science and Health Care, ISSN 2249 – 5738, Issue 6, Vol. 6 (November-December 2016), 1-19.
15. Brahmaiah Bonthagarala, Regulatory Requirements for Marketing of Generic Drugs in USA,International Journal of Pharmaceutical Research and Bio-Science, ISSN: 2277-8713, IJPRBS, 2017; Volume 6(2): 178-195.
16. Brahmaiah Bonthagarala,Guidelines for bioavailability and bioequivalence studies: A Review, The Pharma Innovation Journal 2018; 7(7): 661-666, ISSN (E): 2277- 7695.
17. Brahmaiah Bonthagarala et al, Generic Drug Registration and Regulatory Requirements in European Countries,World Journal of Pharmaceutical Research, 2018, Volume 7, Issue 16, 800-815.