Regulatory
Rapporteur
Write to the Editor at publications@topra.org
January 2025 | Vol. 22 | No. 1
EDITORIAL
Biologics development: Overcoming regulatory hurdles
The January issue of Regulatory Rapporteur focuses on biologics. 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.
By Zeb Younes
FOCUS
Considerations for generics developers moving into the field of biosimilars
There is significant commercial interest in the pharmaceutical industry from established generic manufacturers keen to move into biosimilars. While many generic developers possess the relevant skillsets to allow this, there are challenges to be addressed, especially as biosimilars cannot be shown to be identical to previously authorised products. This article discusses the potential challenges faced and suggests risk mitigation strategies to help ensure successful entry into the biosimilars market.
By Asha Kattige and Zeb Younes
FOCUS
Unique aspects of biologic reference standards
Reference standards are pivotal in ensuring pharmaceutical quality, especially for complex biologics. This article reviews definitions and classifications of reference standards as outlined by the US Food and Drug Administration (FDA), the World Health Organization (WHO) and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q6B and Q7 guidelines.
By Rajendra Kunda, Slobodanka Cirin-Varadjan, Rick Best, Srinivas Yerraguntla, Purnima Shanmugan, Hao Liu and Steve LoCastro
FOCUS
Considerations in the development of allogenic and autologous cell therapies
A key distinction in the field of cell therapy lies in the type of cells used for therapeutic interventions, notably autologous and allogeneic cell therapies. These two strategies, while sharing the common goal of restoring or improving the body’s natural functions, differ significantly in their sources and the challenges they present. This article analyses the benefits and regulatory hurdles of each approach.
By Bethany Aykroyd, Aarti Pattni, Tulasi Yadati and Zeb Younes
STANDALONE
Addressing the challenges of implementing the common technical document in Brazil
The common technical document (CTD) is the standard format for regulatory dossiers, and has the advantage of streamlining submissions, reducing reformatting needs across jurisdictions and saving time and resources. This article presents an overview of CTD implementation, its benefits and the challenges faced by Brazilian industry professionals in adapting to the implementation.
By Jane Cristina da Cruz Barcelos, Juliana Schwarz Rocha, Vanessa Rodrigues Marques, Beatriz Gama Pompeu, Ana Paula Iacuzio Avella and Gustavo Mendes Lima Santos
STANDALONE
Overview of chemical generics registration in China: Challenges for overseas applicants
As China’s regulatory landscape evolves rapidly, international companies face unique challenges in navigating the registration pathway. This article offers 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.
By April Wang
STANDALONE
The role of artificial intelligence in regulatory affairs
This article explores both the enormous potential of artificial intelligence (AI) technologies in regulatory affairs, but also the complexities of integrating it, including the challenges of algorithm interpretability, data quality, regulatory compliance, fairness, security, privacy and model accuracy. It also emphasises the collaborative efforts of the global regulatory community in developing guidelines and frameworks for the safe and effective use of AI.
By Rudy Fuentes, Sean Schofield and Lubomir Zahariev
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