The product is a biosimilar of Johnson & Johnson’s blockbuster arthritis treatment Remicade, which was approved by the European Medicines Agency (EMA) in August 1999. Remicade had worldwide sales of US$9.27 billion in 2013, making it the world’s best-selling medicine and a lucrative target for biosimilars developers. The patent in the US expired in 2011, and in Japan and elsewhere globally the patent is expected to expire in 2014. In the European Union, however, Remicade was granted a six-month paediatric extension giving it patent protection until February 2015.

Epirus has already announced phase I and phase III clinical trial results showing the ‘bioequivalence’ and ‘clinical comparability’ of BOW015 to Remicade [1, 2].

Under the terms of the agreement, Epirus will develop and supply BOW015, and upon regulatory approval Ranbaxy will market the ‘similar biologic’ in India and other emerging markets, including South East Asia and North Africa. In exchange for the rights to BOW015 in the territories, Epirus will receive upfront, milestone and royalty payments over the term of the agreement.

There is currently no infliximab ‘similar biologic’ approved in India. In Europe, the first monoclonal antibody biosimilar [Remsima/Inflectra (infliximab)], which was made as a collaboration between South Korean biotechnology company Celltrion and US-based generics major Hospira, was approved in September 2013 [3]. Celltrion has also gained approval for Remsima in South Korea [4] and Colombia [5], and has applied for approval in Japan [6]. 

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. 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

Biocad and Epirus to invest in biosimilars in Brazil

References

1.  GaBI Online - Generics and Biosimilars Initiative. Positive phase I data for infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 7]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-data-for-infliximab-biosimilar

2.  GaBI Online - Generics and Biosimilars Initiative. Positive phase III data for Epirus infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 7]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-data-for-Epirus-infliximab-biosimilar

3.  GaBI Online - Generics and Biosimilars Initiative. EC approves first monoclonal antibody biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 7]. Available from: www.gabionline.net/Biosimilars/News/EC-approves-first-monoclonal-antibody-biosimilar

4.  GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 7]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea

5.  GaBI Online - Generics and Biosimilars Initiative. Remsima approved in Colombia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 7]. Available from: www.gabionline.net/Biosimilars/News/Remsima-approved-in-Colombia

6.  GaBI Online - Generics and Biosimilars Initiative. Celltrion applies for biosimilar infliximab approval in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Feb 7]. Available from: www.gabionline.net/Biosimilars/News/Celltrion-applies-for-biosimilar-infliximab-approval-in-Japan

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