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"Biosimilar Clinical Development - Opportunities and Challenges" by D.A. Prasanna presented at CPHI Frankfurt, October 2011 |
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“Biologics”, considered one of the fastest growing sectors of the pharmaceutical industry and related clinical research organization services, has introduced many new treatments to life-threatening and rare illnesses. The first generation of biopharmaceutical products manufactured using recombinant technologies was launched in the 1980s, and they are now on the way to patent expiration. As a result, research based and generic pharmaceutical companies alike are pursuing the opportunity to develop “generic” substitutes for original biologics, herein referred to as biosimilars. However, the process of introducing a biosimilar to an innovator product is far more complex than the relatively straightforward process of introducing a generic equivalent to an innovator product based on a new chemical entity. Biologics are produced by cells in culture or whole organisms, which are inherently more variable than chemical synthesis methods. Therefore, unlike generic pharmaceuticals, it is impossible to generate the same or identical copy of an innovator product.
In this way, biosimilars are “similar but not the same” or in other words biosimilars are “the twin but not the clone” to the original biologic innovator product. Therefore the field of biosimilars presents several important challenges, including i) verification of the similarity, ii) the interchangeability of biosimilars and innovator products, iii) the possible need for unique naming to differentiate the various biopharmaceutical products, iv) regulatory framework, v) commercial opportunities as well as guidelines to assist manufacturers in product development, vi) intellectual property rights, and vii) public safety. |
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| "Biosimilar Strategy & 351K", by D. A. Prasanna, at 'CPhI 2014, Paris 2014 |
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| “Stemcell to Market faster”, by D. A. Prasanna, at ‘IsraStem 2013’, Tel Aviv 2013 |
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| “Cell Therapy Trials - How CROs can impact trial outcome” by Dr. S. Kher at Stemcell Symposium, Tel Aviv 2013 |
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| “Speed to Dermatology Market and Clinical Endpoint studies“ by D.A. Prasanna & Nurjehan Jivani at BA&BE; conference, Mumbai, December 2012 |
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| "World’s First Approved Stem Cell Drug“ – May 2012 |
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| "Stem cell therapy clinical development capabilities“ by D A Prasanna, London, March 2010 |
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Read this whitepaper in PDF format  |
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