US-based Epirus Biopharmaceuticals (Epirus) announced on 9 September 2015 that it has acquired Netherlands-based biopharmaceutical company Bioceros Holding (Bioceros).
The deal, which will cost Epirus US$14.1 million, is intended to expand the company’s biosimilars pipeline and development capabilities. Bioceros is focused on the development of monoclonal antibodies (mAbs) and generation of GMP-ready cell lines. Over the past decade, Bioceros has developed numerous biosimilar cell lines from its proprietary, well-characterized CHO platform (CHOBC®).
Bioceros has three preclinical biosimilar candidates to add to the Epirus pipeline. The first, BOW080 is a candidate biosimilar of Alexion Pharmaceuticals’ Soliris (eculizumab), which is indicated to treat ultra-rare blood disorders, including paroxysmal nocturnal hemoglobinuria (PNH) and atypical haemolytic uremic syndrome (aHUS). BOW090 is a candidate biosimilar for Janssen Pharmaceutica’s psoriasis treatment Stelara (ustekinumab). While, finally BOW100 is a candidate biosimilar for Janssen Pharmaceutica’s rheumatoid arthritis treatment Simponi (golimumab).
Epirus expects to file for approval of these biosimilars in 2020 for BOW080, 2021 for BOW090 and 2022 for BOW100. According to Epirus, these three candidate biosimilars represent a global growth opportunity for the company since their reference biologicals are estimated to generate combined 2020 peak sales of US$12 billion.
Mr Amit Munshi, President and Chief Executive Officer, Epirus, said that the ‘combined biosimilar pipeline targets reference biologic[al]s with sales of US$29 billion, which we estimate to be a biosimilar market opportunity of more than US$9 billion’.
Epirus has also made deals for its infliximab biosimilar (BOW015) with biosimilars specialist mAbxience [1] and Ranbaxy [2]. And in fact launched the similar biologic in India in December 2014 [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. 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.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Latin American deal for infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 2]. Available from: www.gabionline.net/Biosimilars/News/Latin-American-deal-for-infliximab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Epirus and Ranbaxy sign agreement for infliximab ‘similar biologic’ [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 2]. Available from: www.gabionline.net/Biosimilars/News/Epirus-and-Ranbaxy-sign-agreement-for-infliximab-similar-biologic
3. GaBI Online - Generics and Biosimilars Initiative. First infliximab ‘similar biologic’ launched in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 2]. Available from: www.gabionline.net/Biosimilars/News/First-infliximab-similar-biologic-launched-in-India
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