ABSTRACT:
This article delves into the world of biosimilars and their role in revolutionizing the pharmaceutical industry. Biosimilars, distinct from generic drugs, are biologic medications developed to closely resemble approved reference biologics. Through an extensive review, this study aims to shed light on the approval process, benefits, and challenges associated with biosimilars. The Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) in India have outlined guidelines for biosimilars, emphasizing the importance of quality, safety, and efficacy comparability to reference biologics. The introduction of interchangeable biosimilars has sparked competition in the biologic market, resulting in cost reductions and enhanced patient access to essential treatments. Interchangeability offers treatment flexibility, potentially improving adherence to therapy. However, concerns regarding immunogenicity, safety and efficacy data gaps, and manufacturing differences persist. Regulatory agencies play a pivotal role in designating biosimilars as interchangeable, ensuring their suitability for substitution without prescriber intervention. India's biopharmaceutical industry has emerged as a formidable player, producing a significant number of biosimilars. While challenges like harmonizing regulations, quality assurance, and fostering innovation persist, India's focus on biosimilars aligns with the global trend toward cost-effective biological therapies.
Cite this article:
Khan Adil Ahmed*, Dr. G.J. Khan.Biosimilars in India: Pioneering Affordable Innovations in Global Healthcare. IJRPAS, Sep-Oct 2023; 2(5): 1-12.
1.
Matli MC, Wilson AB, Rappsilber LM,
Sheffield FP, Farlow ML, Johnson JL. The first interchangeable biosimilar
insulin: insulin glargine-yfgn. Journal of Diabetes Science and Technology.
2023 Mar;17(2):490-4.
2.
Panda S,
Singh PK, Mishra S, Mitra S, Pattnaik P, Adhikary SD, Mohapatra RK. Indian
Biosimilars and Vaccines at Crossroads–Replicating the Success of
Pharmagenerics. Vaccines. 2023 Jan 2;11(1):110.
3.
Shinde VA, Patil R, Bhandari P, Borkar P,
Yadav S. A Pharmacoeconomic Outlook of the Biological Drugs Marketed in India:
A Cost Variance Analysis. Cureus. 2023 Jan 18;15(1)
4.
Klein K,
Gencoglu M, Heisterberg J, Acha V, Stolk P. The global landscape of
manufacturers of follow-on biologics: an overview of five major biosimilar
markets and 15 countries. BioDrugs. 2023 Mar;37(2):235-45.
5.
Stevenson JG, McCabe D, McGrath M, McBride
A. Pharmacist biosimilar survey reveals knowledge gaps. Journal of the American
Pharmacists Association. 2023 Mar 1;63(2):529-37.
6.
Gascón P, Goldsmith D, Aapro M, Dellanna
F, Esmael A, Zabransky M. Epoetin alfa biosimilar (HX575): a review of 15
years’ post-approval clinical experience. Critical Reviews in
Oncology/Hematology. 2022 Dec 5:103894.
7.
Yada PK.
Expanding Footprints of Biosimilar Tenecteplase. Annals of Indian Academy of
Neurology. 2023 Apr 28.
8.
Leone GM, Mangano K, Petralia MC,
Nicoletti F, Fagone P. Past, Present and (Foreseeable) Future of Biological
Anti-TNF Alpha Therapy. Journal of Clinical Medicine. 2023 Feb 17;12(4):1630.
9.
Car E, Vulto AG, Houdenhoven MV, Huys I,
Simoens S. Biosimilar competition in European markets of TNF-alpha inhibitors:
a comparative analysis of pricing, market share and utilization trends.
Frontiers in Pharmacology. 2023 Apr 21;14:1151764.
10.
Zeng X, Jia Y, Chen H, Luo Q, Zhao H,
Liang G, Chen W, Li Y. A real-world analysis of survival and cost-effectiveness
of sintilimab plus bevacizumab biosimilar regimen in patients with advanced
hepatocellular carcinoma. Journal of Cancer Research and Clinical Oncology.
2023 May 16:1-7.
11. Patel
A, Bhatt N, Prakash SS, Biswas G, Nagarkar R, Roy B, Samal P, Agrawal N,
Meshram S, Kaushal A, Satheesh CT. Rituximab biosimilar for the treatment of
diffuse large B-cell lymphoma: a phase 3 randomized study in India. Cancer Chemotherapy
and Pharmacology. 2023 Jun;91(6):457-68.
12. Bashir
NS, Hughes A, Ungar WJ. Infliximab Pricing in International Economic
Evaluations in Inflammatory Bowel Disease to Inform Biologic and Biosimilar
Access Policies: A Systematic Review. MDM Policy & Practice. 2023
Feb;8(1):23814683231156433.
13. Yu
T, Jin S, Li C, Chambers JD, Hlávka JP. Factors Associated with Biosimilar
Exclusions and Step Therapy Restrictions Among US Commercial Health Plans.
BioDrugs. 2023 Apr 1:1-0.
14. Padda
IS, Bhatt R, Rehman O, Parmar M. Biosimilars use in medicine for inflammatory
diseases.