Mergers and collaborations are still in vogue in the biosimilars arena. The latest firms to announce deals are Epirus Biopharmaceuticals (Epirus), which will merge with Zalicus; and Catalent, which has agreed to a biosimilar development collaboration with Zhejiang Hisun Pharma.
US-based Epirus announced on 16 April 2014 that the company had entered into a definitive agreement under which Epirus will merge with a wholly-owned subsidiary of US biologicals company Zalicus in an all-stock transaction. The merged company will operate under the Epirus name and will be focused on building a global biosimilar enterprise. Epirus is currently developing a pipeline of biosimilars, including BOW015, a biosimilar to Remicade (infliximab), BOW050, a biosimilar to Humira (adalimumab), and BOW030 a biosimilar to Avastin (bevacizumab).
Epirus Switzerland, a subsidiary of US-based Epirus Biopharmaceuticals, has also signed a licensing agreement for BOW015 with India-based Ranbaxy Laboratories [1]. Phase I and phase III clinical trial results for BOW015 have shown the ‘bioequivalence’ and ‘clinical comparability’ of BOW015 to Johnson & Johnson’s blockbuster arthritis treatment Remicade (infliximab) [2, 3].
The company has also managed to secure US$36 million in investment capital. The investment will finance further clinical development of BOW015, with an additional phase III clinical trial for BOW015 in Europe planned to start in early 2015, as well as ongoing development of BOW050 and BOW030.
Meanwhile, US-based Catalent Pharma Solutions, a provider of development solutions and drug delivery technologies, announced on 3 April 2014 the signing of an agreement with Chinese generics maker Zhejiang Hisun Pharmaceuticals (Hisun), to provide Hisun with a broad range of biosimilar cell lines, using Catalent’s proprietary GPEx technology for the Chinese market. Under the agreement, Hisun will produce a broad range of biosimilars, including adalimumab, alemtuzumab and infliximab.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Epirus and Ranbaxy sign agreement for infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 9]. Available from: www.gabionline.net/Biosimilars/News/Epirus-and-Ranbaxy-sign-agreement-for-infliximab-biosimilar
2. GaBI Online - Generics and Biosimilars Initiative. Positive phase I data for infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 May 9]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-I-data-for-infliximab-biosimilar
3. 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 May 9]. Available from: www.gabionline.net/Biosimilars/Research/Positive-phase-III-data-for-Epirus-infliximab-biosimilar
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Source: Catalent, Epirus, Zalicus
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