Regulatory Rapporteur
January 2025 | Volume 22 | No.1
Welcome to 2025! Our first issue of the year focuses on biologics drug development.
Despite the heterogeneity and complexity of biological medicinal products, we see continued growth in drug development in this area. Recent efforts include the development of biosimilars, modified traditional biologics (such as multi-site specific antibody-derived fusion proteins), tissue, cell and gene therapies and an array of pandemic vaccines.
Our first article, by Asha Kattige and Zeb Younes of Scendea, is relevant to those new to biologics but experienced with generics. It provides key considerations for the stepwise development of biosimilars, discusses the main differences in the development approach and summarises the main risks faced by developers and possible mitigation strategies.
Our second article, by Rajendra Kunda, Slobodanka Cirin-Varadjan, Rick Best, Srinivas Yerraguntla, Purnima Shanmugan, Hao Liu and Steve LoCastro of Syneos Health, discusses the unique aspects of biologics reference standards. Reference standards are pivotal in ensuring pharmaceutical quality, especially for complex biologics. This article reviews definitions and classifications of reference standards, lifecycle management and characterisation. It includes discussion on the two-tiered reference standard programmes and prevention of potency drift. The more recent development of international standards for monoclonal antibodies and their application in biosimilar development is also addressed.
Our next article, by Bethany Aykroyd, Aarti Pattni, Tulasi Yadati and Zeb Younes of Scendea, presents key considerations in the development of allogenic and autologous cell therapies. It outlines the definitions and general manufacturing processes of allogenic and autologous cell therapies and discusses the unique development challenges, in terms of regulatory hurdles, chemistry, manufacturing and controls (CMC), nonclinical studies and clinical development.
Our fourth article moves the issue to a more regulatory focus by addressing the challenges of implementing the common technical document (CTD) in Brazil. Authored by Jane Cristina da Cruz Barcelos of the University of Lisbon, Juliana Schwarz Rocha of N.G. Reis Consulting Ltd, Vanessa Rodrigues Marques of the University of São Paulo, Beatriz Gama Pompeu of the State University of Campinas, Ana Paula Iacuzio Avella of Triade Regulatory Solutions and Gustavo Mendes Lima Santos of Instituto Butantã, this article presents an overview of CTD implementation, its benefits and the challenges faced by Brazilian industry professionals in its adoption.
Our next article, by April Wang of Accestra Consulting, is the fifth article in a six-part series focusing on the regulations in China’s drug market. It presents a comprehensive overview of the generic chemical drug registration process in China, providing essential insights for overseas applicants into key application procedures, timelines, costs and document requirements. The article outlines the registration framework and highlights the specific regulatory hurdles of the Chinese market.
Our final article this month, by Rudy Fuentes, Sean Schofield and Lubomir Zahariev of the PPD clinical research business of Thermo Fisher Scientific, looks to the future and the role of artificial intelligence in regulatory affairs. It explores the potential of artificial intelligence (AI) technologies in regulatory affairs, highlighting how AI can streamline regulatory compliance, expedite submissions, enhance predictive analytics for decision-making, improve pharmacovigilance and elevate regulatory intelligence when properly applied.
Happy reading!
