Author(s): Nikhil Kute, S. D. Mankar, S. B. Bhawar


DOI: 10.52711/2321-5836.2022.00015   

Address: Nikhil Kute*, S. D. Mankar, S. B. Bhawar
Pravara Rural College of Pharmacy, Pravaranagar.
*Corresponding Author

Published In:   Volume - 14,      Issue - 2,     Year - 2022

Biosimilars are biological products that are the replicas of their innovator biopharmaceuticals. The term “biosimilar” is in common use in the European Union, while the term “follow on biologics” is more popular in the American context. These are developed after patent expiration of innovator biopharmaceuticals and are submitted for separate marketing approval. In view of the structural and manufacturing complexities of biopharmaceuticals, biosimilars should not be considered as “biological generics”. These are rather unique molecules with limited data at time of approval, so there are concerns about the safety and efficacy of biosimilars. The Indian biotechnology industry is also gaining momentum, with revenues of over U.S. $ 2.0 billion in 2006, 70% of which is biopharmaceuticals. These are projected to reach up to $580 million in 2012.This article will address the differences between biosimilars and chemical generics, issues of concern with the use of biosimilars and need of appropriate regulations for their approval.

Cite this article:
Nikhil Kute, S. D. Mankar, S. B. Bhawar. Biosimilar and it’s Current Perspective – A Review. Research Journal of Pharmacology and Pharmacodynamics.2022;14(2):84-8. doi: 10.52711/2321-5836.2022.00015

Nikhil Kute, S. D. Mankar, S. B. Bhawar. Biosimilar and it’s Current Perspective – A Review. Research Journal of Pharmacology and Pharmacodynamics.2022;14(2):84-8. doi: 10.52711/2321-5836.2022.00015   Available on:

1.    Alten R, Cronstein BN (2015) Clinical trial development for biosimilars. Semin Arthritis Rheum 44(2015): S2–S8
2.    Nowicki M. Basic facts about Biosimilars. Kidney Blood Press Res. 2007; 30: 267–72.[PubMed] [Google Scholar]
3.    Arbogast LW, Delaglio F, Schiel JE, Marino JP (2017) Multivariate analysis of 2D 1H, 13C methyl NMR spectra of monoclonal antibody therapeutics to facilitate assessment of higher order structure. Anal Chem 89(21):11839–11845.
4.    Biosimilar medicines: Overview [Internet]. London (UK): European Medicines Agency; c1995–2018 [cited 2019 Jan 5]. Accessed 5 Jan 2019
5.    Yang Danlin, Singh Ajit, Helen Wu, Kroe-Barret Rachel (2016) Comparison of biosensor platforms in the evaluation of high affinity antibody-antigen binding kinetics. Anal Biochem 508:78–96.
6.    DiMasi JA, Grabowski HG, Hansen RW (2016) Innovation in the pharmaceutical industry: new estimates of R&D costs. J Health Econ 47:20–33.
7.    Aladul, M.I.; Fitzpatrick, R.W.; Chapman, S.R. Healthcare professionals’ perceptions and perspectives on biosimilar medicines and the barriers and facilitators to their prescribing in UK: A qualitative study. BMJ Open 2018, 8, 11 e023603.
8.    Giuliani, R.; Tabernero, J.; Cardoso, F.; McGregor, K.H.; Vyas, M.; De Vries, E.G.E. Knowledge and use of biosimilars in oncology: A survey by the European Society for Medical Oncology. ESMO Open 2019, 4, e000460.
9.    Park, S.K.; Moon, W.; Kim, E.S.; Park, S.H.; Park, D. Il Knowledge and Viewpoints on Biosimilar Monoclonal Antibodies among Asian Physicians: Comparison with European Physicians. Korean J. Gastroenterol. 2019, 74, 333–340.
10.    Schellekens H. Biosimilarepoetins: How similar are they? Eur J Hosp Pharm. 2004;3:43–7.[Google Scholar]
11.    Haselbeck A. Epoetins: Differences and their relevance to immunogenicity. Curr Med Res Opin. 2003;19:430–2. [PubMed] [Google Scholar]
12.    Locatelli F, Del Vecchio L, Pozzoni P. Pure red-cell aplasia “epidemic”—mystery completely revealed? Perit Dial Int. 2007;27(Suppl 2):303–7.[PubMed] [Google Scholar]
13.    Oberg K, Alm G. The incidence and clinical significance of antibodies to interferon-α in patients with solid tumors. Biotherapy. 1997;10:1–5. [PubMed] [Google Scholar]
14.    Li J, Yang C, Xia Y, Bertino A, Glaspy J, Roberts M, et al. Thrombocytopenia caused by the development of antibodies to thrombopoietin. Blood. 2001;98:3241–8. [PubMed] [Google Scholar]
15.    Locatelli F, Roger S. Comparative testing and pharmacovigilance of biosimilars. Nephrol Dial Transplant. 2006;21(Suppl 5):13–6. [PubMed] [Google Scholar]
16.    Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19:411–9. [PubMed] [Google Scholar]
17.    Duerden M. Prescribing advice needed for new biosimilar biological drugs. Prescriber. 2007;18:1–2. [Google Scholar]
18.    Joshi SR. BiosimilarInsulins: Are they really ‘similar′? JAPI. 2009;57:38–41. [Google Scholar]
19.    Europa BIO. Bioindustry welcomes new French legislation covering biosimilar medicines. [Last accessedon 2007 Feb 21]. Available from: .
20.    Hodgson J. WHO guidelines presage US biosimilars legislation? Nat Biotechnol. 2009;27:963–5. [PubMed] [Google Scholar]
21.    Hodgson J. WHO guidelines presage US biosimilars legislation? Nat Biotechnol 2009;27:963‑5.
22.    C. Baldamus, S. Krivoshiev, M. Wolf-Pflugmann, et al. Long-term safety and tolerability of epoetin zeta, administered intravenously, for maintenance treatment of renal anemia Adv Ther, 25 (2008), pp. 1215-1228

Recomonded Articles:

Author(s): Ghanshyam Sevak, Yashpal Singh Chauhan, Narendra Parihar, Mahendra Singh Rathore

DOI: 10.52711/2321-5836.2022.00018         Access: Closed Access Read More

Author(s): Nikhil Kute, S. D. Mankar, S. B. Bhawar

DOI: 10.52711/2321-5836.2022.00015         Access: Closed Access Read More

Research Journal of Pharmacology and Pharmacodynamics (RJPPD) is an international, peer-reviewed journal....... Read more >>>

RNI: Not Available                     
DOI: 10.5958 2321-5836 

Recent Articles