Module 9 2021

For biologicals in particular

• The relatively new concept of biosimilar biotechnology derived medicinal products has already been realised in the EU

• This has been a tour de force of collaboration between the CHMP and industry and places Europe far ahead in global achievement

• Founded in part on the principles comparability, the discipline has been enabled by proactive regulation

Regulation of Biosimilars Cecil Nick

The Organisation for Professionals in Regulatory Affairs

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For biologicals in particular

• With the exception of vaccines, the immunogenicity of a biological product is potentially an undesirable attribute

• It must be fully characterised and its consequences evaluated in the context of its potential or actual impact on both product potency and safety in preclinical and clinical studies • Subtle changes in product quality can have far reaching immunological effects which might (and in some cases have) radically alter the benefit/risk balance adversely

Immunogenicity Issues Isabelle Cludts

The Organisation for Professionals in Regulatory Affairs

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