Merck Millipore to collaborate with Turkish firm on biosimilars

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Merck Millipore to collaborate with Turkish firm on biosimilars

Home/Pharma News | Posted 06/11/2015 0 Post your comment

The Life Science division of Merck, Merck Millipore and Turkish biosimilars start-up Turgut Ilaç are to collaborate on biosimilars.

The two companies announced on 22 October 2015 that they had entered into a strategic alliance during which Merck Millipore will provide their Provantage End-to-End Services for development and manufacturing of biologicals.

Under this multi-year agreement with Turgut Ilaç, Merck Millipore will provide process development, equipment for a pilot facility, cGMP (Current Good Manufacturing Practice) manufacturing, facility design and ultimately, technology transfer of the manufacturing process to Turgut’s facility for commercial production.

Phase I of the agreement will focus on monoclonal antibody biosimilars for non-small cell lung carcinoma and rheumatoid arthritis.

‘Turgut Ilaç was one of the founding companies of the pharmaceutical sector in Turkey and one of the first to develop generics’, according to Mr Kaya Turgut, Founder and Chairman of the Board.

Family-owned Turgut Ilaç was one of the first generics companies to emerge in Turkey in 1951. Their small-molecule business was sold to Actavis in 2003. The company expects to commercially manufacture biosimilars in a facility just outside Istanbul.

Another notable biosimilars deal for Turkey includes that of Russian non-originator biologicals manufacturer Biocad, who signed an agreement with Turkish oncology specialist Koçak Farma for the export of biosimilar darbepoetin alfa active pharmaceutical ingredients (APIs) in 2013 [1].

Editor's comment
It should be noted that ‘biosimilars’ approved in Turkey 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.

Related article
Attitudes towards generics in Turkey

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biocad signs deal for biosimilar darbepoetin alpha in Turkey [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 6]. Available from: www.gabionline.net/Biosimilars/News/Biocad-signs-deal-for-biosimilar-darbepoetin-alpha-in-Turkey

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Source: Merck Millipore