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Turkish approval for rituximab biosimilar Redditux Posted 01/06/2018

Turkish pharma start-up firm TRPharm announced on 9 March 2018 that it had received Turkish approval and was ready to launch its rituximab biosimilar Redditux.

The company gained approval for Redditux on 30 January 2018 for the treatment of non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic lymphoma (CLL). The product was developed by Dr Reddy’s Laboratories (Dr Reddy’s) and first approved by Indian health authorities on 22 March 2007[1]. It is currently used by physicians and patients in more than 17 countries.

Dr Reddy’s and TRPharm entered into a strategic collaboration agreement for a portfolio of similar biotherapeutic products (SBP) in Turkey back in March 2016 [2]. A total of three SBPs 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.

Mehmet Göker, Chairman and Chief Executive Officer of TRPharm pointed out that the approval of Redditux marks ‘the first monoclonal antibody (mAb) drug substance to be produced in Turkey’. He added that the company is looking forward to ‘continued expansion of this vision beyond Turkey and into the rest of the MENA region’.

Editor’s comment
It should be noted that ‘similar biologics’ approved in India and similar biotherapeutic products 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.

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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 2018 Jun 1]. Available from: www.gabionline.net/Biosimilars/General/Similar-biologics-approved-and-marketed-in-India
2. GaBI Online - Generics and Biosimilars Initiative. Dr Reddy’s and TRPharm collaborate on biosimilars in Turkey [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Jun 1]. Available from: www.gabionline.net/Pharma-News/Dr-Reddy-s-and-TRPharm-collaborate-on-biosimilars-in-Turkey

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Source: TRPharm

Comments (2)

Response to Reditux posted 05/06/2018 - by Louis B, GaBI Online Editorial Office

Dear Glenn R Pilkington, Thank you for your valuable comments and insight received on 4 June 2018. Upon checking, please be advised that Redditux was not approved under the Indian guidelines for ‘Similar Biologic’ established in 2012, it was approved in 2007. We appreciate very much your kind feedback. Thank you for your interest in GaBI, and please continue with your valuable comments to GaBI Online. Best Regards, Louis

Reditux posted 04/06/2018 - by Glenn R Pilkington

Reditux was not approved in India as a "Biosimilar", under the Indian "Biosimilar Guidelines", but as a "Similar Biologic", prior to establishment of the guidelines.

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