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Oncobiologics and IPCA create biosimilars alliance Posted 13/06/2014

US-based Oncobiologics announced on 2 June 2014 the creation of a two-part alliance for the development, manufacture and commercialization of biosimilar monoclonal antibodies with Indian generics maker IPCA Labs (IPCA).

Under the first part of the agreement, IPCA will in-license and commercialize biosimilars for India and associated markets. These products will be developed by Oncobiologics to US Food and Drug Administration (FDA) and European Union regulatory standards for global commercialization.

In the second part, Oncobiologics will replicate its biologicals R & D and manufacturing facility in India to create a world-class capability for IPCA for further biosimilar commercialization. Oncobiologics expects the R & D facility, which will be designed for the development and commercialization of complex monoclonal antibodies, to be operational in 2015 and the manufacturing facility to be operational by 2016.

Although the biosimilars in question are not mentioned, Oncobiologics states in its press release that they ‘are among the most popular therapies in the world for immunology and oncology disease indications’. These are likely to include biosimilars of Roche’s cancer and arthritis treatments Avastin (bevacizumab), Herceptin (trastuzumab) and Rituxan (rituximab), Eli Lilly’s cancer drug Erbitux (cetuximab) and Abbott’s arthritis treatment Humira (adalimumab), all of which are ‘in the pipeline’ according to the website of Oncobiologics.

Oncobiologics also made biosimilars agreements in 2013 with Viropro and Zhejiang Huahai Pharmaceutical for the development, manufacture and commercialization of several biosimilar monoclonal antibodies [1, 2].

Oncobiologics expects this latest partnership to launch its first biosimilar in 2017.

References

1. GaBI Online - Generics and Biosimilars Initiative. Oncobiologics and Viropro make biosimilar deal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 13]. Available from: www.gabionline.net/Biosimilars/News/Oncobiologics-and-Viropro-make-biosimilar-deal

2. GaBI Online - Generics and Biosimilars Initiative. Huahai and Oncobiologics make biosimilars deal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 13]. Available from: www.gabionline.net/Biosimilars/News/Huahai-and-Oncobiologics-make-biosimilars-deal

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