The deal will give Elpen the rights to distribute Avesthagen’s biosimilar darbepoetin alfa (Avdesp) in seven European Union (EU) and six non-EU territories. The countries included in the agreement are Albania, Bosnia, Bulgaria, Croatia, Cyprus, Former Yugoslav Republic of Macedonia, Greece, Kosovo, Montenegro, Romania, Slovenia, Slovakia and Serbia, covering a population of over 70 million.

Avdesp is a biosimilar of Amgen’s blockbuster Aranesp (darbepoetin alfa) and will be used for the treatment of anaemia resulting from chronic kidney disorders and cancer chemotherapy.

Avesthagen is working with contract research organization, PRA International, to carry out the phase I clinical trial for Avdesp in The Netherlands followed by a phase III clinical trial in India.

The company says that it is working with different outsourcing organizations to make sure the product comes to the market at the earliest opportunity. In the EU, the patent on Enbrel will expire on 6 July 2016, whereas in the US the patent will only expire in 2024 [1]. Aranesp had 2012 sales in excess of US$2 billion.

Avesthagen already has ‘similar biologics’ on the market in India [2] and is also developing an etanercept biosimilar [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 approval of biosimilars in the European Union. 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

Competing biosimilars to Amgen’s biologicals

References

1.  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 2013 Dec 13]. Available from: www.gabionline.net/Biosimilars/General/US-67-billion-worth-of-biosimilar-patents-expiring-before-2020

2.  GaBI Online - Generics and Biosimilars Initiative. Biosimilars to replace 70% of chemical drugs [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Dec 13]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-to-replace-70-of-chemical-drugs

3.  GaBI Online - Generics and Biosimilars Initiative. Development of biosimilars for rheumatology [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Dec 13]. Available from: www.gabionline.net/Biosimilars/Research/Development-of-biosimilars-for-rheumatology

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