How do concerns about the safety of domestic biologicals limit the uptake of ‘similar biologics’ in India? This is a question that author Malipatil tried to address in his review of similar biologics in India [1].
Despite the high acceptance of similar biologics in India, some physicians remain sceptical with regards to the safety and efficacy of similar biologics and are slow to adopt these drugs. One problem with all biologicals is immunogenicity, or their ability to induce a humoral and/or cell-mediated immune response. This was highlighted in the late 1990s when cases of pure red cell aplasia (PRCA) were reported after the formulation of Eprex (epoetin alfa) was changed [2].
Although patients, physicians, insurance providers and the Indian Government are attracted by the cost savings offered by similar biologics compared to originator biologicals, there remain concerns regarding the safety, efficacy and quality of these products. This is mainly due to the lack of stringent evaluation guidelines from the Indian drug regulatory system.
This lack of stringent regulation is highlighted by the fact that noticeable differences in potency have been found between several Indian similar biologics compared to their reference biologicals. A study carried out by Boehringer Ingelheim revealed that the India-registered Elaxim (tenecteplase; Emcure) was not a similar biologic to Metalyse (tenecteplase; Boehringer Ingelheim). The study also concluded that differences in the manufacturing process had introduced impurities that affected the potency and efficacy of the similar biologic. Similarly, Roche conducted studies comparing their originator biological Rituxan (rituximab) with Reditux (rituximab; Dr Reddy’s) and highlighted numerous differences including a much higher level of remaining host cell proteins in Reditux compared to Rituxan, as well as differences in glycosylation.
Conflict of interest
The authors of the research paper [1] declared that there were no conflicts of interest.
Editor’s comment
It should be noted that ‘similar biologics’ approved in India might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.
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References
1. Malipatil NB, Haridas KM, Shruthi DP. Biosimilars and regulations: a review. J Pharm Biomed Sci. 2015;05(06):453-68.
2. GaBI Online - Generics and Biosimilars Initiative. Epoetin alfa and pure red cell aplasia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Feb 26]. Available from: www.gabionline.net/Biosimilars/Research/Epoetin-alfa-and-pure-red-cell-aplasia
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