A total of three biosimilars will be registered and subsequently commercialized as a part of the agreement. TRPharm will also manufacture the drug substance and drug product once it completes its biotech manufacturing facility.

Executive Vice President & Head Branded Markets (India and Emerging countries), M V Ramana, said that ‘Turkey is a key emerging market’ for Dr Reddy’s and that this ‘partnership will also enable Dr Reddy’s to widen the global footprint of its biosimilar business’.

TRPharm has already begun laying out the groundwork for the technology transfer. The collaboration will contribute to TRPharm’s ongoing biologicals development and manufacturing business in the region.

The companies did not state which biosimilars will be involved in the agreement. Dr Reddy’s already markets four ‘similar biologics’ (darbepoetin alfa, filgrastim, peg-filgrastim, rituximab) in India [1] and a similar biotherapeutic product (rituximab) in several Latin American countries (Bolivia, Chile, Ecuador, Paraguay, Peru) [2].

Editor’s comment
It should be noted that ‘similar biologics’ approved in India and ‘similar biotherapeutic products’ approved in Latin America and ‘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
Merck KGaA and Dr Reddy’s to collaborate on biosimilar mAbs

References
1.    GaBI Online - Generics and Biosimilars Initiative. ‘Similar biologics’ approved and marketed in India [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Apr 8]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
2.    GaBI Online - Generics and Biosimilars Initiative. Similar biotherapeutic products approved and marketed in Latin America [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Apr 8]. Available from: www.gabionline.net/Biosimilars/General/Similar-biotherapeutic-products-approved-and-marketed-in-Latin-America

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