Julphars Director of #Biotechnology Essam Hammad talks about the role of Biosimilars: Generic pharmaceutical companies play a vital role in the biotechnology industry, as it allows Patients to benefit from more affordable, accessible and just as effective biologic medications known as biosimilars. Generic Companies are able to reproduce Biosimilars following patent and exclusivity expiry on the original product. Only after rigorous approval methods and clinical validation take place by the FDA or EMA, Biosimilar manufacturing can begin. Biosimilars are generic medical products whose active substance is made from a living organism, or derived from a living organism by means of human recombinant DNA or controlled gene expression methods. There are significant opportunities for creating a robust biosimilars industry in the region. Europe has already approved the first monoclonal antibody biosimilar, and the US is finalizing its guidelines. The MENA region, however, hasn’t yet initiated structured dialogue on how to address the regulations. Julphar aims to bring together all relevant stakeholders from the private and public sectors to decide on the best ways to establish this platform. Julphar is taking the steps in bringing the UAE up to speed with other markets to develop its own biosimilar and biotechnology sector, rather than depending on imports. Imported medicines are more expensive and supply can be interrupted, affecting accessibility. Establishing our own UAE Biotechnology industry certainly doesn’t come without challenges. Countries in the MENA region do not have a common regulatory framework to approve medicines; every product has to be approved by each individual country. This presents a huge obstacle to innovation in the region and can potentially drive investors away from the business. Biotechnology and biosimilars require huge investments. The advanced diabetes plant which we established in 2012 cost $150m. For more information on Biotechnology visit the Julphar website julphar.net
Posted on: Wed, 22 Jan 2014 07:14:59 +0000
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