According to Sandoz the new draft guideline ‘safeguards patient safety without compromising access to these important therapies’. Points to note in the draft revision include:

• The power of pharmacokinetics (PK) and pharmacodynamic (PD) studies in demonstrating biosimilarity over traditional efficacy trials involving large numbers of patients is emphasized.
• Strategies involving non-approved indications and non-inferiority trial designs may also be acceptable in certain circumstances.
• EMA suggests that laboratory studies be conducted before determining whether any human trials are necessary.

Sandoz supports EMA in recognizing the importance of considering the totality of evidence – analytical, preclinical and clinical data – when determining the extent of data required for the extrapolation of safety across indications, but requests that the agency provides ‘more concrete language around the requirements for extrapolation in its final guideline’. The company is still to provide comprehensive feedback to the agency on the draft guideline.

Sandoz has a vested interest in making sure its opinion is taken into account when new guidelines for biosimilars are developed. Sandoz currently has more than two biosimilars on the market and the company has 8–10 molecules at various stages of development [1].

EMA released a revision of the guideline addressing the clinical and non-clinical issues related to biosimilars on 10 June 2013 and feedback can be submitted to EMA until the end of November 2013 [2].

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Reference

1.  GaBI Online - Generics and Biosimilars Initiative. Everybody jumping on the biosimilars bandwagon [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 21]. Available from: www.gabionline.net/Biosimilars/News/Everybody-jumping-on-the-biosimilars-bandwagon   

2.  GaBI Online - Generics and Biosimilars Initiative. Revision of guideline on clinical and non-clinical issues for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Jun 21]. Available from: www.gabionline.net/Guidelines/Revision-of-guideline-on-clinical-and-non-clinical-issues-for-biosimilars

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