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The authors have reviewed applications of novel technologies in the major stages of biosimilars development: process development, pharmacology, toxicology, and clinical trials, with an emphasis on recent regulatory requirements.
Editor’s Note: This paper was reviewed by a member of BioPharm International®’s Editorial Advisory Board.
Peer-reviewed
Article submitted: Jan. 11, 2024.
Article accepted: Feb. 6, 2024.
Biosimilars have transformed access and cost of healthcare globally. There has been an explosion of technological advances in biotechnology and computational systems in the past decade. Regulations have also evolved to meet technological advances; for example, exploring real-world evidence to inform regulatory decisions is mandated by the 21st Century Cures Act. The authors have reviewed applications of these novel technologies in the major stages of biosimilars development: process development, pharmacology, toxicology, and clinical trials, with an emphasis on recent regulatory requirements. The advances in process development include process analytical technology and multivariate analysis methods for real-time monitoring and analysis of critical quality attributes and continuous manufacturing processes, which can reduce the manufacturing footprint and increase efficiencies. The applications of artificial intelligence/machine learning in pharmacology, toxicology, and clinical trials have been reviewed. These processes have accelerated development time and decreased cost of biosimilars development. Regulatory considerations on quality aspects of biosimilars are listed as well as some of the major challenges in biosimilars development.
FDA defines biosimilars as biological products that are highly similar to and have no clinically meaningful differences from existing FDA-approved reference products in terms of safety, purity, and potency (1). Since the first approval of a biosimilar in 2015 (1), the US healthcare system has saved approximately $338 billion (2). The 21st Century Cures Act of 2016 mandates FDA to accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently (3). The regulatory pathways for biosimilar development have evolved to meet the requirements of industry, law, markets, and most importantly, the patient (4,5).
BioPharm International® spoke with Zara Bukhari, a PhD scholar at the University of the Pacific, Stockton, CA, and co-author of the peer-review research paper, Biosimilars Drug Development: Advances in Technologies from Molecule Design to Clinical Trials, published in the July/August 2024 issue, about process development for biosimilars.
Over the past two decades, technological advances and enhancements have improved the process of establishing biosimilarity, which has an impact on global regulatory guidance (6). Some of these technologies range from gene-editing of cell lines to continuous operation of upstream and downstream processes for enhancing operational aspects of manufacturing (4). New instrumentation technologies have enhanced the accuracy and precision of measuring primary, secondary, and tertiary structures of proteins (7,8). Process analytical technology (PAT) and multi-attribute methods (MAMs) have enabled real-time decision-making (9,10). The use of machine learning algorithms has improved predictive methods for pharmacology and toxicology. Finally, the use of adaptive clinical trials and real-world evidence methods have enhanced robustness in clinical assessments of endpoints.
Zara Bukhari is PhD scholar at the University of the Pacific, Stockton, CA. Farogh Gibraiel is senior downstream process development specialist at Polpharma Biologics S.A., Warsaw, Poland. Smritie Sheth is scientist; Chaitrali Bakhale is consultant, and Narendra Chirmule is CEO, all at SymphonyTech Biologics, Philadelphia, Pa.
BioPharm International®
Vol. 37, No. 7
July/August 2024
Page: 28
When referring to this article, please cite it as Bukhari, Z.; Gibraiel, F.; Sheth, S.; Bakhale, C.; Chirmule, N. Biosimilars Drug Development: Advances in Technologies from Molecule Design to Clinical Trials. BioPharm International 2024 37 (7).
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