Darbepoetin alfa is a synthetic form of erythropoietin, which stimulates erythropoiesis (increases red blood cell levels) in patients with anaemia due to chronic kidney disease or cancer chemotherapy. More than 100,000 new patients in India every year need renal replacement therapy, i.e. dialysis, and chronic kidney disease is a rapidly growing issue in India. Drugs such as darbepoetin alfa are therefore essential to maintain haemoglobin levels and reduce the need for blood transfusions.

The ‘similar biologic’ will be marketed in collaboration with Indian generics maker Cipla. This will be Cipla’s second ‘similar biologic’. The company launched its first ‘similar biologic’ Etacept (etanercept), which is a version of Amgen’s arthritis blockbuster Enbrel (etanercept), in India in April 2013 [1].

Actorise is a ‘similar biologic’ of Amgen’s blockbuster anaemia treatment Aranesp (darbepoetin alfa). The patents on Aranesp are set to expire in Europe in July 2016 and in the US in May 2024 [2].

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 EU. 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.

Related article

‘Similar biologics’ approved and marketed in India

References
1. GaBI Online - Generics and Biosimilars Initiative. Cipla launches first etanercept ‘similar biologic’ in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 20]. Available from: www.gabionline.net/Biosimilars/News/Cipla-launches-first-etanercept-similar-biologic-in-India
2. GaBI Online - Generics and Biosimilars Initiative. US$67 billion worth of biosimilar patents expiring before 2020 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 20]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020

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