Biopharmaceuticals, drugs produced by live cell culture, have a fast growing market for the treatment of a range of conditions. Despite their clinical importance, however, their cost could impose an increasing burden on either national healthcare systems or patients’ out-of-pocket expenses. The potential for reducing the costs of biopharmaceuticals is therefore attracting the attention of policymakers in the health sector.
One of the most promising avenues for reducing costs is the manufacture of cheaper versions of biopharmaceuticals, known as biosimilars, once the original patents have expired. To date 14 biosimilars have been approved by the European Medicines Agency (EMA) and are now on the market in the EU. Given the large size and complex nature of biological molecules, however, it is practically impossible to manufacture ‘identical’ copies. The key concept of ‘biosimilarity’ in published guidelines which cover the approval of biopharmaceutical copies relies on a head-to-head clinical comparison to a reference originator biopharmaceutical. However, this might not be the case for the approval and marketing of biopharmaceuticals in poorly regulated markets. Biosimilars in these markets may therefore have different definitions. Some experts believe that performing head-to-head preclinical and clinical trials between brand-name products and biosimilars may not be necessary and that this might deprive patients of effective and affordable treatment.
Iran’s Government has allocated substantial resources for supporting local pharmaceutical companies to manufacture biopharmaceuticals. In Iran, local manufacturers have been producing biopharmaceuticals for the past decade, including copies of non-originator products, such as erythropoietins, interferon and growth hormone. But these have yet to undergo the same rigorous evaluation as products approved as biosimilars in Europe or USA. Pharmaceutical companies in Iran do not have access to the same manufacturing processes as those used for producing originators, including cell cultures, fermentation and purification procedures. They cannot, therefore, claim ‘similarity’ between their copies and the originator brands. However, this situation is likely to change in the future as new science-based companies continue to become established as producers of new biopharmaceuticals.
Until now, the registration of these copied biopharmaceuticals in Iran has mainly followed the registration path for ‘biogeneric’ medicines [1]. Since 2003, Iran’s national regulatory authority (NRA) has registered six copies of branded biopharmaceuticals. Another 16 are in the pipeline and are expected to reach the Iranian market in the coming years.
Although the Iranian NRA has tried to use the WHO guideline on biosimilars for granting marketing authorization, this differs from the current Iranian national guideline for registration of locally produced biopharmaceuticals. Although there are national laws and regulations for the protection of patents and brands registered by Iranian companies inside Iran, these do not apply to foreign companies or products registered outside Iran, because Iran is not currently a member of the World Trade Organization. Providing that local pharmaceutical companies have access to the production procedures for biopharmaceuticals, they would be able to manufacture both patented and off‑patent biopharmaceuticals in Iran.
Although biosimilars have proven to be a cost-effective intervention, regulatory approaches proposed for marketing of these medicines by EMA, FDA or WHO may not suit the needs of the Iranian market. In order to create a balance between regulation of locally produced biopharmaceuticals and their availability and affordability, Iran NRA has used national pharmacovigilance capacity as a tool in regulation of locally manufactured biopharmaceuticals. Currently, the Iranian NRA accepts pharmacokinetic and pharmacodynamic equivalence between the originator and locally manufactured biopharmaceuticals along with a small clinical safety study before granting marketing authorization. Iran then uses a rigorous pharmacovigilance approach to monitor for immunogenicity or other important adverse events following the use of locally produced biopharmaceuticals.
Abstracted by Professor Abdol Majid Cheraghali, Member of International Editorial Advisory Board, GaBI Journal.
Editor’s comment
Readers interested to learn more of the pharmaceutical market in Iran are invited to visit www.gabi-journal.net to view the following peer reviewed manuscript in GaBI Journal:
Current status of Biopharmaceuticals in the Iran Pharmaceutical Market
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Production of 24 biosimilars in Iran by 2012
Reference
1. Cheraghali A M. Biosimilars; a unique opportunity for Iran national health sector and national pharmaceutical industry. DARU Journal of Pharmaceutical Sciences 2012;20:35. Available from: http://www.darujps.com/content/20/1/35
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