India-based generics manufacturer Cipla announced on 17 April 2013 the launch of its ‘similar biologic’ product Etacept, the first ‘similar biologic’ of etanercept in India.
Etacept is ‘similar biologic’, as the Indian regulatory authorities call these products, of Amgen’s arthritis blockbuster Enbrel. The product is a result of Cipla’s collaboration with China-based Shanghai CP Guojian Pharmaceutical and marks Cipla’s entry into the ‘similar biologic’ market.
Cipla has been working on ‘similar biologic’ since 2010, when it acquired a 40% stake in Goa-based Mab Pharm and a 25% stake in Bio Mabs, Shanghai [1]. The company is introducing Etacept at a 30% discount compared to the innovator price. To which Cipla’s Medical Director Dr Jaideep Gogtay, commented that this would ‘enable access of this drug to a greater number of patients in India’.
Dr Gogtay added that ‘the higher cost of biologic[al]s has been a major hindrance, limiting its affordability and accessibility to millions of patients’. He also pointed out that savings could be ‘enhanced further if we consider the results of a recent study that showed in patients who were successfully treated with etanercept for six months, a 50% reduced dose worked just as well as continuing the current dose’.
Similar biologics have been on the market in India for some years already and India has by far shown the greatest acceptance of such products. However, regulatory guidelines for similar biologics were only implemented in September 2012. Prior to this similar biologics were approved in India following the generics pathway, but with more data being required [2].
The main patent on Enbrel in the US was set to expire in October 2012, but has been extended until 22 November 2028, and in Europe patents are expected to expire in February 2015 [3].
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 biosimilars in the EU. EMA 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
Cipla enters the biosimilars market
References
1. GaBI Online - Generics and Biosimilars Initiative. Cipla invests in biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 19]. Available from: www.gabionline.net/Biosimilars/News/Cipla-invests-in-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 19]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
3. GaBI Online - Generics and Biosimilars Initiative. New Amgen Enbrel patent could block biosimilars until 2028 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 19]. Available from: www.gabionline.net/Biosimilars/News/New-Amgen-Enbrel-patent-could-block-biosimilars-until-2028
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