Date: 27 November 2012 Source: Essentialdrugs.org
Dear colleagues
Since the past decade some newly established science based Iranian pharmaceutical companies started projects on developing biopharmaceuticals. The Iran government has also allocated substantial resources for supporting local pharmaceutical companies to manufacture biopharmaceuticals. Pharmaceutical companies in Iran as a non WTO member do not have access to the production procedures of originators including cell type, fermentation and purification procedures. Therefore they could not claim “biosimilarity” for their products to those of originator brand.
Despite the fact that biopharmaceuticals that were produced by the local Iranian industry in the past decade including INFs, GCSF and GH have received marketing authorization for the local market, none of them received formal evaluation according to those of international guidelines for “Biosimilars”. Since 2003 locally produced biopharmaceuticals including erythropoeitins, INFs, Factor VIIa, GH and GCSF have been registered by the Iran national authority as “non originator copy”. Another 16 are in the pipeline and expected to reach Iran market with a similar approach in coming years.
Although Iran NRA has tried to use WHO guidelines on Biosimilars for granting marketing authorization, there are clearly differences between WHO guidelines and current Iran national guidelines for registration of locally produced biopharmaceuticals. In Iran if a local pharmaceutical company could have access to the production procedures of biopharmaceuticals, it would be able to manufacture both patent and off patent biopharmaceuticals. Some scientists in Iran believe that the WHO biosimilar guideline is mainly adapted from EMA guidelines and there is no proof that this guideline is in fact in line with the needs and interests of national pharmaceutical markets in low resourced countries such as Iran.
For more information on the subject click on following link: [Biosimilars; a unique opportunity for Iran national health sector and national pharmaceutical industry by Abdol M Cheraghali, DARU Journal of Pharmaceutical Sciences] http://www.darujps.com/content/20/1/35
-- Professor Majid Cheraghali Tehran- Iran Fax: (9821) 88601580 Tel: (9821) 88601582 cheraghali@ibto.ir
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