Evolution of biological agents: how established drugs can become less safe

Casadevall, Nicole; Floßmann, Oliver; Hunt, David

doi:10.1136/bmj.j1707

Cited by 5 publications

(1 citation statement)

References 31 publications

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“…Since the 1980s, there has been a significant increase in biologics research and production, leading to notable advancements in the creation of novel therapeutic strategies for diseases, including cancer, immunological disorders, and rare genetic illnesses, among others [6]. The creation, manufacturing, and synthesis of a wide variety of complex designer molecular, protein, gene, cell, and tissue-based agents capable of highly selective targeting have expanded the scope of science, which was once limited to the extraction of naturally occurring chemicals [9].…”

Section: Introductionmentioning

confidence: 99%

A Proposed Global Medicines Agency (GMA) to Make Biological Drugs Accessible: Starting with the League of Arab States

Niazi

2023

Healthcare

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Medical anthropology teaches us of historical disparity in the accessibility of medicines in the developing world due to their lack of availability and affordability, more particularly of biological drugs, including therapeutic proteins, gene therapy, CRISPR-Cas9, mRNA therapeutics, CART therapy, and many more. This challenge can be resolved by establishing an independent regulatory agency, proposed as the Global Medicines Agency (GMA), with a charter to allow originators from the Stringent Regulatory Agency (SRA) countries to receive immediate registrations applicable to all member states, expanding the market potential as an incentive. For non-SRA countries, it will be limited to biological drugs that are allowed their copies to be made, only biosimilars. A transparent approval process will involve using a rapporteur, a third-party product-related current Good Manufacturing Practice (cGMP), and assurance of the integrity of samples tested for analytical similarity and clinical pharmacology testing. GMA membership will be open to all countries. Still, it is suggested that the League of Arab States, representing 22 states with a population of 400 million, takes the lead due to their cultural and language homogeneity, which is likely to provide a concurrence among the member states. However, some states, like the Gulf Cooperative Council, are already accustomed to this approach, albeit with a different perspective. The target drugs are biotechnology and gene therapy pharmaceuticals, and their scope can be expanded to any drug.

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Section: Introductionmentioning

confidence: 99%