Russia’s biggest drugmaker, Pharmstandard, and investment company, Millhouse LLC, have said that they are planning to buy 70% of Russian biosimilars developer Biocad.
Biocad to be taken over by Russian investment firm
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Posted 02/06/2014
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The companies announced on 22 May 2014 that they would acquire stakes in Biocad Holding, the main shareholder in Biocad. Under the terms of the deal, Pharmstandard will acquire 20% of Biocad Holding, while a Millhouse-affiliated entity will purchase a further 50% stake, with the remaining 30% being retained by Biocad founder and CEO, Mr Dmitry Morozov.
Biocad was previously reported to be attracting offers from US-based Pfizer and biotechnology giant Amgen [1].
Biocad received approval for its rituximab non-originator biological, AcellBia (BCD-20) from the Russian Ministry of Health in April 2014. The drug is a non-originator biological of Roche’s rheumatoid arthritis blockbuster MabThera/Rituxan (rituximab) [2].
According to ClinTrials.gov Biocad is also carrying out phase III clinical trials for two of its other non-originator biological candidates, BCD-021 and BCD-022. The products are non-originator biologicals of Roche’s blockbuster cancer drugs Avastin (bevacizumab) and Herceptin (trastuzumab) [1].
Editor’s comment
It should be noted that ‘non-originator biologicals’ approved in Russia 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. Amgen and Pfizer seek deal with Russian biosimilars firm [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 2]. Available from: www.gabionline.net/Pharma-News/Amgen-and-Pfizer-seek-deal-with-Russian-biosimilars-firm
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilar rituximab approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jun 2]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-rituximab-approved-in-Russia
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Source: Pharmstandard
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