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Hetero launches adalimumab similar biologic in India Posted 25/05/2018

India-based generics maker Hetero Group (Hetero) announced in January 2018 the launch of its product Mabura, a ‘similar biologic’ of adalimumab, in India.

Mabura is a similar biologic of AbbVie’s Humira (adalimumab), which was approved by the US Food and Drug Administration in December 2002 and by the European Medicines Agency in September 2003 [1]. Humira is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

Zydus Cadila claimed to be ‘the first company anywhere in the world to launch a biosimilar of adalimumab’. They also claimed that their similar biologic, Exemptia, is a ‘fingerprint match with the originator in terms of safety, purity and potency of the product’ [2].

Mabura is Hetero’s fourth similar biologic to be launched in India. The company launched its first ‘similar biologic’ product, Actorise, a ‘similar biologic’ of darbepoetin alfa, in India in June 2014. This was followed by launches of ‘similar biologics’ of rituximab (Maball) in August 2015 and bevacizumab (Cizumab) in June 2016 [3].

Mabura will be manufactured at Hetero’s dedicated state-of-the-art manufacturing facility for biologics, based at Hyderabad, India.

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.

Related article
Biosimilars of adalimumab

1.  Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
2.  GaBI Online - Generics and Biosimilars Initiative. Adalimumab similar biologic launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 25]. Available from: www.gabionline.net/Biosimilars/News/Adalimumab-similar-biologic-launched-in-India
3.  GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 May 25]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India

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Source: Hetero

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