Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs)
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Guidelines on evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs)
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The objective of this paper is to provide considerations based on comprehensive case studies important for regulatory evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs) with a special emphasis on clinical aspects. Scientific principles from WHO Guidelines on SBPs were used as a basis for the exercise. Working groups consisted of regulators, manufacturers and academia....
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REFERENCES 1. Scientific considerations in demonstrating biosimilarity to a reference product: guidance for industry. US FDA; 2015. 2. Guidelines on evaluation of similar biotherapeutic products (SBPs). WHO; 2009. 3. Guideline on similar biological medicinal products. EMA; 2014. 4. Column proportions test [user guide]. IBM Corporation; 2013. 5. Leading autoimmune patient advocacy group survey f...
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