LETTER TO THE EDITOR
Year : 2019 | Volume
: 67 | Issue : 8 | Page : 1384--1385
Ophthalmic biosimilars: Lessons from India
Ashish Sharma1, Nilesh Kumar1, Baruch D Kuppermann2, Bandello Francesco3, Anat Lowenstein4,
1 Department of Vitreoretina, Lotus Eye Hospital and Institute, Coimbatore, Tamil Nadu, India
2 Gavin Herbert Eye Institute, University of California, Irvine, CA, USA
3 Department of Ophthalmology, University Vita-Salute, Scientific Institute San Raffaele, Milano, Italy
4 Division of Ophthalmology, Tel Aviv Sourasky Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Israel
Dr. Ashish Sharma
Department of Vitreoretina, Lotus Eye Hospital and Institute, Coimbatore - 641 014, Tamil Nadu
|How to cite this article:|
Sharma A, Kumar N, Kuppermann BD, Francesco B, Lowenstein A. Ophthalmic biosimilars: Lessons from India.Indian J Ophthalmol 2019;67:1384-1385
|How to cite this URL:|
Sharma A, Kumar N, Kuppermann BD, Francesco B, Lowenstein A. Ophthalmic biosimilars: Lessons from India. Indian J Ophthalmol [serial online] 2019 [cited 2020 Jul 8 ];67:1384-1385
Available from: http://www.ijo.in/text.asp?2019/67/8/1384/263143
India has been on the forefront of biosimilar development for ophthalmic therapeutics by developing and commercially marketing Razumab® (Intas Pharmaceuticals, Ahmedabad, India), the first commercially available biosimilar to Ranibizumab (Leucentis®), an innovator molecule (Genentech, South San Francisco, CA, USA). Many other similar molecules are in the Reserach and Development (R&D) phase globally. Razumab was approved for the Indian market in 2015 for clinical use and has grown its user base rapidly. This is reflected by the fact that the number of units sold in 2018 alone were almost equal to the total sale of Razumab since its launch. (Unpublished data from manufacturer).
Yet a major hindrance in the success of Razumab is the occurrence of adverse drug reaction (ADR) sterile endophthalmitis, being reported for specific batches of Razumab, putting a question on its safety. ADR is an inherent part of any drug administration and has been reported in innovator molecules also. However, cluster occurrence in specific batches of Razumab brings the interbatch variability to the limelight, and puts a question on the quality control. To counteract the nocebo about these complex molecules being perceived as generic drugs with lower safety and efficacy, stricter guidelines to validate the postapproval inter batch comparability of biosimilars should be enforced.
There are many potential ophthalmic biosimilar molecules which would be entering the global market in the next few years. Manufacturers of these molecules can take the following lessons from India.
There is a need of biosimilars especially in developing countries where the presence of compounding pharmacies is rare. It is an opportunity for ophthalmic biosimilar manufacturers globally.Strict pharmacovigilence and the careful choice of immunogenicity testing assay prior to market approval can reduce the nocebo effect around these molecules.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
|1||Sharma A, Reddy P, Kuppermann BD, Bandello F, Loewenstein A. Biosimilars in ophthalmology: Is there a big change on the horizon? Clin Ophthalmol 2018;12:2137-43.|
|2||Available from: https://www.moneycontrol.com/news/business/companies/exclusive-complaints-prompt -intas-to-recall-batch -of-biosimilar -razumab-in-india-2251273.html. [Last cited on 2019 Mar 03].|
|3||Souied EH, Dugel PU, Ferreira A, Hashmonay R, Lu J, Kelly SP. Severe ocular inflammation following ranibizumab or aflibercept injections for age-related macular degeneration: A retrospective claims database analysis. Ophthalmic Epidemiol 2016;23:71-9.|
|4||Sharma A, Kumar N, Kuppermann BD, Francesco B, Loewenstein A. Biotherapeutics and immunogenicity: ophthalmic perspective. Eye 2019 Apr 09.|