Thursday, December 13, 2012

Biosimilars: The complex process to determine safety and efficacy

To bring a biomilar to market is difficult.  One of the most challenging parts of the process is copying the original innovator product.  Dove Press published a paper that takes an in-depth looking to this process.

Here's an excerpt on the looking at that topic:

Various complexities associated with approval of a biosimilar include: i) evidence of integrity and consistency of the manufacturing process, ii) conformance of manufacturing standards to applicable regulations, iii) demonstration of product consistency with appropriate innovator product or comparators using assays that should be relevant and most of all standardized, so that several biosimilars of the same biologic can be comparable, including comparative pharmacokinetic and pharmacodynamic data and the extent of clinical data, and iv) experience with the approved product. (12)   Further, issues like post-translation modification and immunogenicity are the key concern related to approval of biosimilar products.13 Scientists are of the opinion that the use of biosimilars is an opportunity for us to use cutting-edge technology to solve health problems and guide clinical processes.

12. Covic A, Cannata-Andia J, Cancarini G, et al. Biosimilars and biopharmaceuticals: what the nephrologists need to know – a position paper by the ERA-EDTA Council. Nephrol Dial Transplant. 2008;23: 3731–3737.

Read the full white paper here.

This year,the Biopharmaceutical Production and Development Week will address Biosimilar Development and Production in detail focusing on the develop biosimilars for the global market through critical understanding of market dynamics and regulatory challenges, precise analytical characterization and innovative production.  For more information on this portion of the program, download the agenda.  If you'd like to join us in register by December 14 and mention BDPW13BLOG to save $300 off the standard price! 

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