Indian Journal of Rheumatology 2012 JuneVolume 7, Number 2; pp. 67e68 Editorial

Biosimilars in rheumatology; the new kid in the block:Panacea or pandoras box?

Krishnan Shanmuganandana,*, Darshan S. Bhakunib

“From inability to let well alone; from too much zeal for thenew and contempt for what is old; from putting knowledgebefore wisdom, science before art and cleverness beforecommon sense; from treating patients as cases; and frommaking the cure of the disease more grievous than theendurance of the same, Good Lord, deliver us.” so saidSir Robert Hutchison, the well known 20th centuryphysician.1 This aphorism would aptly pertain to theinherent dichotomy in the world of biosimilars which arethe “new kids in the block”.

Biosimilars are new biopharmaceutical agents that are‘similar’ but not identical to a reference biopharmaceuticalproduct.2 The term biosimilars has been used loosely in thepast few years that has resulted in considerable confusionand ambiguity. The word Biosimilar is actually a shortform and derived from “similar biological medicinal prod-ucts”. In fact the WHO definition of biosimilar is simpleand pithy. It defines biosimilars as “A biotherapeuticproduct which is similar in terms of quality, safety and effi-cacy to an already licensed reference biotherapeuticproduct”.3 The field of biosimilars is in a nascent stageand it is only apt that the Indian Journal of Rheumatologyis bringing out a review article on biosimilars. The world-wide explosion in the field of biosimilars have mainlyresulted from parent expiry of original drug manufacturersof biological response modifiers in the recent past andforthcoming few months.

In this issue of journal, Chopra and Shankar haveembarked upon the mission to unravel the various facetsof use of biosimilars with particular emphasis on rheuma-tology.4 To the uninitiated, this article has given a compre-hensive overview of this hithertofore unexplored andexciting field of biopharmaceuticals. They have givena detailed review on the pharmacobiology of biosimilars

aSenior advisor (Rheumatology), bConsultant and HOD Rheumatology, Arm*Corresponding author. email: kshanmu5520@yahoo.comAvailable online: 10.5.2012Copyright � 2012, Indian Rheumatology Association. All rights reserved.doi:10.1016/j.injr.2012.04.014

and described succinctly the current status of biosimilarsin the rheumatology world. In addition they have discussedaptly the problems and perils that may be associated with itsinappropriate use quoting real time examples like that oferythropoietin biosimilars having caused irreversible purered cell aplasia in the last decade.5

WHY IS THERE A SURGE OF INTEREST INBIOSIMILARS?

Firstly, many of the biological agents have gone or aregoing off patent in the ensuing years.4,6 Secondly, thesebiosimilars have a huge potential market in a highly popu-lated country like India.7 Thirdly, India is a leading playerin biosimilars market with greatest technological knowhow, manufacturing and market capabilities as evidencedby the fact of over 50 biopharmaceutical brands gettingmarketing approval.7 The Indian pharmaceutical industryin India has matured over the years into a major producerof bulk drugs, rated among the top five in the world. TheIndian biotechnology industry is also showing an exponen-tial growth with projected revenues of $580 million by2012.8 Last but not the least, there is wealth of evidencethat the use of biologicals has revolutionized the treatmentof rheumatic diseases wherein they can arrest the diseaseprocess early and prevent disability and morbidity.9

However due to its exorbitant cost it remains beyond thereach of majority of Indian patients.10,11 With the introduc-tion of biosimilars the price fall will be exponential andpossibly more patients will be able to afford thesebiologicals.

Hence Indian initiatives in this direction to address thecore issues with the use of biosimilars in rheumatology

y Hospital Research & Referral, New Delhi 110010, India.

68 Indian Journal of Rheumatology 2012 June; Vol. 7, No. 2 Shanmuganandan and Bhakuni

may auger well for patients with systemic rheumaticdiseases.4

WHAT ARE THE CONCERNS WITH USE OFBIOSIMILARS?

As biosimilars may be made by different manufacturingprocesses including reverse engineering and as the clinicalexperience in real world situation as opposed to trialsettings with biosimilars at the time of their approvaldue to truncated drug development may be limited, thedifferences in efficacy and safety of biosimilars maybecome evident at a later date. In addition it will bea daunting task to assess the efficacy of biosimilars incomparison to innovator molecules due to lack of central-ised biological registries in India, and also poor postmarketing surveillance. A head to head trial comparingthese two molecules will be essential to facilitate decisionmaking process by Indian rheumatologists who will alsoconsider cost benefit ratio when prescribing biologicalmodifier therapies.

The concerns of use of biosimilars enumerated above arereal and logical and hence the advantages accrued due toreduced costs and availability to Indian patients can beaugmented by strict pharmacovigilance, stringent criteriafor the evaluation of quality, safety and efficacy and reliablepost marketing surveillance. Only time will tell whetherbiosimilars will ultimately translate into better health caredelivery to the clientele.

REFERENCES

1. José Henrique M, Scheliga. Riches of Poverty. J Clin Oncol.July 20. 2010;28(no. 21):3541e3542.

2. Misra M. Biosimilars: current perspectives and future implica-tions. Indian J Pharmacol. 2012;44:12e14.

3. GaBI Online e Generics and Biosimilars Initiative. EMAproposes more precise definition for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma CommunicationsInternational; [cited 2012 Mar 9]. Available from: www.gabionline.net/Biosimilars/Research/EMA-proposes-more-precise-definition-for-biosimilars.

4. Arvind Chopra, Subramanian Shankar. Biosimilar DMARD inrheumatology: a general perspective with focus on India.Indian J Rheumatol. 2012;7(2):65e66.

5. Casadevall N, Eckardt KU, Rossert J. Epoetin-induced auto-immune pure red cell aplasia. J Am Soc Nephrol.2005;16(suppl 1):S67eS69.

6. Maity S, Ullanat R, Lahiri S, et al. A non-innovator version ofetanercept for treatment of arthritis. Biologicals. 2011;39(6):384e395.

7. OPPI position paper on ‘Biosimilar’ in India. Available from:http://www.indiaoppi.com/oppibiosimilars.pdf.

8. Thomas TK. Patent for biosimilar drugs may be made manda-tory. The Hindu Business Line (Published on May 06, 2008).Available from: http://www.thehindubusinessline.in/2008/05/06/stories/2008050651531000.htm.

9. Saag KG, Teng GG, Patkar NM, et al. American college ofrheumatology 2008 recommendations for the use of nonbio-logic and biologic disease-modifying antirheumatic drugs inrheumatoid arthritis. Arthritis Rheum. 2008;59:762e784.

10. Malaviya AN, Kapoor S, Garg S, Ahmad I, Raja RR. A newstrategy of drug treatment in NSAID-unresponsive ankylosingspondylitis: combination of pamidronate and methylpredniso-lone monthly intravenous infusions on the background ofa combination of disease modifying drugs sulfasalazine andmethotrexate. J Assoc Physicians India. 2007 Mar;55:193e197.

11. Kakar A, Kumar A. Current status of combination therapywith disease modifying antirheumatic drugs in rheumatoidarthritis. J Indian Rheumatol Assoc. 2002;10:36e44.