Biopharmaceuticals: A Review of Biopolymeric Drugs and Accessibility Challenges in India

Open Access

Year : 2024 | Volume :12 | Special Issue : 05 | Page : 32-38
By

Dr. Arvind Singh Farswan,

Dr. Sumit Joshi,

Dr. Ritu Sanwal,

Dr. Archna Dhsamana,

  1. Assistant Professor, Department- Himalayan School of Pharmaceutical Science, Swami Rama Himalayan University, Jolly Grant, Dehradun,, Uttarakhand, India
  2. Assistant Professor, Department of pharmacy, Siddhartha Institute of Pharmacy, Dehradun,, Uttarakhand, India
  3. Professor, Department of pharmacy, Shanti Niketan College of Pharmacy, Mandi,, Himachal Pradesh, India
  4. Assistant Professor, Department-Himalayan School of Bioscience, Swami Rama Himalayan University, Jolly Grant, Dehradun,, Uttarakhand, India

Abstract

Advances in biotechnology have allowed us to produce biosynthesized proteins that have therapeutic benefits. The drug products having biotechnology derived proteins, i.e. Biopharmaceuticals, have evolved the treatment of several diseases. knowledge about biological systems have been explored scientifically, there have been significant efforts to utilize them for improving human lives. These biopharmaceutical products have a rapidly growing market which needs to be closely monitored to avoid any potential risks. This review emphasizes on the scenario of the biopharmaceutical products available in India and some important aspects to be considered to facilitate their safe use. Biologics are defined by the Central Drug Control Organization (CDSCO) as ‘drugs derived from any natural source (microorganism, animal or human).’ Indian Pharmacopoeia Commission (IPC) Biologics are comprised of proteins, sugars, nucleic acids, or a blend of these components, and may also encompass living organisms like cells and tissues. Since the biotechnological methods used to obtain these biologics are not economical, this makes these products extremely unaffordable to the majority of the population in developing nations. Continued investments in research, infrastructure, and talent development will be essential to harness the full potential of polymeric biopharmaceuticals and address unmet medical needs in India and beyond.

Keywords: Biopharmaceutical, Therapeutic Benefits, Biologics, Indian Pharmacopoeia, Genetic Engineering, Polymer.

[This article belongs to Special Issue under section in Journal of Polymer and Composites (jopc)]

How to cite this article:
Dr. Arvind Singh Farswan, Dr. Sumit Joshi, Dr. Ritu Sanwal, Dr. Archna Dhsamana. Biopharmaceuticals: A Review of Biopolymeric Drugs and Accessibility Challenges in India. Journal of Polymer and Composites. 2024; 12(05):32-38.
How to cite this URL:
Dr. Arvind Singh Farswan, Dr. Sumit Joshi, Dr. Ritu Sanwal, Dr. Archna Dhsamana. Biopharmaceuticals: A Review of Biopolymeric Drugs and Accessibility Challenges in India. Journal of Polymer and Composites. 2024; 12(05):32-38. Available from: https://journals.stmjournals.com/jopc/article=2024/view=172203


References

  1. Gámez-Belmonte R, Hernández-Chirlaque C, Arredondo-Amador M, Aranda CJ, González R, Martínez-Augustin O, de Medina FS. Biosimilars: Concepts and controversies. Pharmacological research. 2018 Jul 1;133:251-64.
  2. Evens R, Kaitin K. The evolution of biotechnology and its impact on health care. Health Affairs. 2015 Feb 1;34(2):210-9.
  3. Crommelin DJ, Mastrobattista E, Hawe A, Hoogendoorn KH, Jiskoot W. Shifting paradigms revisited: biotechnology and the pharmaceutical sciences. Journal of Pharmaceutical Sciences. 2020 Jan 1;109(1):30-43.
  4. Carter PJ, Lazar GA. Next generation antibody drugs: pursuit of the’high-hanging fruit’. Nature Reviews Drug Discovery. 2018 Mar;17(3):197-223.
  5. Gherghescu I, Delgado-Charro MB. The biosimilar landscape: an overview of regulatory approvals by the EMA and FDA. Pharmaceutics. 2020 Dec 31;13(1):48.
  6. Sethi R, Popli H, Sethi S. Medical devices regulation in United States of America, European Union and India: A comparative study. Pharm. Regul. Aff. 2017.
  7. Yadav S, Atif M, Rawal G. Nikshay Poshan Yojana-another step to eliminate TB from India. IP Indian J Immunol Respir Med. 2018;3(2):28-9.
  8. Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United States: initial experience and future potential. Rand health quarterly. 2018 Mar;7(4).
  9. Mulcahy AW, Hlávka JP, Case SR. Biosimilar cost savings in the United States. Rand Corporation Perspective. 2017.
  10. La Noce A, Ernst M. Switching from reference to biosimilar products: an overview of the European approach and real-world experience so far. EMJ. 2018 Sep;3(3):74-81.
  11. Ghosh PK. Similar biologics: Global opportunities and issues. Journal of Pharmacy & Pharmaceutical Sciences. 2016;19(4):552-96.
  12. Davies M, Dahl D, Heise T, Kiljanski J, Mathieu C. Introduction of biosimilar insulins in Europe. Diabetic Medicine. 2017 Oct;34(10):1340-53.
  13. Halimi V, Daci A, Ancevska Netkovska K, Suturkova L, Babar ZU, Grozdanova A. Clinical and regulatory concerns of biosimilars: a review of literature. International journal of environmental research and public health. 2020 Aug;17(16):5800.
  14. Minghetti P, Rocco P, Del Vecchio L, Locatelli F. Biosimilars and regulatory authorities. Nephron Clinical Practice. 2010 Aug 3;117(1):c1-7.
  15. CDSCO I. Guideline on similar biologics: Regulatory Requirements for Marketing Authorization in India. New Delhi. 2016:1-53.
  16. Herring RJ. State science, risk and agricultural biotechnology: Bt cotton to Bt Brinjal in India. Journal of Peasant Studies. 2015 Jan 2;42(1):159-86.
  17. Meher BR, Balan S, Mohanty RR, Jena M, Das S. Biosimilars in India; current status and future perspectives. Journal of Pharmacy and Bioallied Sciences. 2019 Jan 1;11(1):12-5.
  18. Agrawal NK, Gupta U. Present status of department of health research registered ethics committees in India after implementation of new drugs and clinical trials rules 2019. Journal of Medical Evidence. 2022 Sep 1;3(3):211-8.
  19. Ghagne S, Nerli R, Baligar P, Hiremath M. Status and Application of Recombinant DNA Therapeutic products used in Clinical practices: An Indian scenario. Available at SSRN 2783940. 2016 May 24.
  20. Krishnan A, Mody R, Malhotra H. Global regulatory landscape of biosimilars: emerging and established market perspectives. Biosimilars. 2015 Feb 17:19-32.
  21. Lemery SJ, Esteva FJ, Weise M. Biosimilars: here and now. American Society of Clinical Oncology Educational Book. 2016 Jan 1;36:e151-7.
  22. Halim LA, Brinks V, Jiskoot W, Romeijn S, Haselberg R, Burns C, Wadhwa M, Schellekens H. Quality and batch-to-batch consistency of original and biosimilar epoetin products. Journal of pharmaceutical sciences. 2016 Feb 1;105(2):542-50.
  23. Schiestl M, Stangler T, Torella C, Čepeljnik T, Toll H, Grau R. Acceptable changes in quality attributes of glycosylated biopharmaceuticals. Nature biotechnology. 2011 Apr;29(4):310-2.
  24. Lissy M, Ode M, Roth K. Comparison of the pharmacokinetic and pharmacodynamic profiles of one US-marketed and two European-marketed epoetin alfas: a randomized prospective study. Drugs in R & D. 2011 Mar;11:61-75.
  25. Locatelli F, Lucia Del V, Pozzoni P. Pure red-cell aplasia “epidemic”—mystery completely revealed?. Peritoneal dialysis international. 2007 Jun;27(2_suppl):303-7.
  26. Mazur M, Olek-Hrab K, Karczewski J, Teresiak-Mikołajczak E, Adamski Z. Biosimilars in dermatology. Advances in Dermatology and Allergology/Postępy Dermatologii i Alergologii. 2015 Oct 29;32(5):384-7.
  27. Kotarek J, Stuart C, De Paoli SH, Simak J, Lin TL, Gao Y, Ovanesov M, Liang Y, Scott D, Brown J, Bai Y. Subvisible particle content, formulation, and dose of an erythropoietin peptide mimetic product are associated with severe adverse postmarketing events. Journal of Pharmaceutical Sciences. 2016 Mar 1;105(3):1023-7.
  28. Meher BR, Balan S, Mohanty RR, Jena M, Das S. Biosimilars in India; current status and future perspectives. Journal of Pharmacy and Bioallied Sciences. 2019 Jan 1;11(1):12-5.
  29. Nilsson BL, Soellner MB, Raines RT. Chemical synthesis of proteins. Annu. Rev. Biophys. Biomol. Struct.. 2005 Jun 9;34:91-118.
  30. Liu H, Li X. Serine/threonine ligation: origin, mechanistic aspects, and applications. Accounts of chemical research. 2018 Jul 6;51(7):1643-55.
  31. Agrawal NK, Gupta U. Present status of department of health research registered ethics committees in India after implementation of new drugs and clinical trials rules 2019. Journal of Medical Evidence. 2022 Sep 1;3(3):211-8.
  32. Aguirre TA, Teijeiro-Osorio D, Rosa M, Coulter IS, Alonso MJ, Brayden DJ. Current status of selected oral peptide technologies in advanced preclinical development and in clinical trials. Advanced drug delivery reviews. 2016 Nov 15;106:223-41.
  33. Granhall C, Søndergaard FL, Thomsen M, Anderson TW. Pharmacokinetics, safety and tolerability of oral semaglutide in subjects with renal impairment. Clinical Pharmacokinetics. 2018 Dec;57:1571-80.
  34. Zhao Z, Ukidve A, Dasgupta A, Mitragotri S. Transdermal immunomodulation: Principles, advances and perspectives. Advanced Drug Delivery Reviews. 2018 Mar 1;127:3-19.
  35. Lazarus RA, Wagener JS. Recombinant human deoxyribonuclease I. Pharmaceutical biotechnology: fundamentals and applications. 2019:471-88.
  36. Maguire MG, Martin DF, Ying GS, Jaffe GJ, Daniel E, Grunwald JE, Toth CA, Ferris III FL, Fine SL, Comparison of Age-related Macular Degeneration Treatments Trials (CATT) Research Group. Five-year outcomes with anti–vascular endothelial growth factor treatment of neovascular age-related macular degeneration: the comparison of age-related macular degeneration treatments trials. Ophthalmology. 2016 Aug 1;123(8):1751-61.
  37. Al-Worafi YM. Storage and disposal of medications. InDrug safety in developing countries 2020 Jan 1 (pp. 137-142). Academic Press.
  38. Mehta SB, Roy S, Yang HC. “Product on stopper” in a lyophilized drug product: cosmetic defect or a product quality concern? Journal of Pharmaceutical Sciences. 2018 Jun 1;107(6):1736-40.
Special Issue Open Access Review Article
Volume 12
Special Issue 05
Received March 1, 2024
Accepted July 16, 2024
Published July 31, 2024
Views: 32

Check Our other Platform for Workshops in the field of AI, Biotechnology & Nanotechnology.
Learn more
Check Out Platform for Webinars in the field of AI, Biotech. & Nanotech.
Learn more