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Global biosimilars guideline development – EGA’s perspective Posted 28/09/2009

Biosimilar guidelines and regulations are being developed all over the world, as outlined at the 7th EGA Annual Symposium on Biosimilars recently held in London, UK by Ingrid Schwarzenberger, Head Regulatory Affairs Biopharmaceuticals at Sandoz and member of European Generic medicines Association’s (EGA) European Biopharmaceutical Group.
Countries with biosimilar guidelines
Jurisdiction hurdle “This is unnecessary, unethical (because it requires duplication of preclinical and clinical studies) and uneconomical,” stressed Ms Schwarzenberger. “Reference products are often the same or highly similar in different countries, even though licensed under different jurisdictions. Often, documentation is available in the public domain, confirming that the products are the same. Comparability of reference products of one original manufacturer from different highly regulated countries (EU, US) can be clearly established by stringent analytical and functional studies. Under these premises it should not be required to duplicate preclinical and clinical studies for each country or region.” According to Ms Schwarzenberger, there should be a way to let a science-based approach towards global development overcome the regulatory burden. “The first step should be the obligation by applicants to show comparability between a biosimilar and the relevant reference products. The next step (if necessary) should be the exchange of information on reference products between regulators in the context of confidentiality agreements. The importance of this issue is demonstrated by inclusion of biosimilar development into the ‘EU-FDA Transatlantic Simplification Initiative’. The current pharmacovigilance activities require ‘single identification of medicines’. Global development is a must to remain competitive and financially viable. It is the only way to improve worldwide availability, affordability and access to biosimilars,” she concluded.
As pointed out by Ms Ingrid Schwarzenberger, the European regulations, the Japanese guideline, and probably also the future US legislation, require the use of a reference product authorised in their jurisdiction. This would mandate the performance of separate, full-development programmes for each ICH country/region utilising the reference products authorised in each region. ICH stands for ‘The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use’.
Source: EGA
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