仿制药追赶原研药：一致性评价不可沦为“一次性评价”

Core Viewpoint - The increase in mycoplasma infections leading to pneumonia has raised concerns about the choice between generic and original drugs, with a focus on the effectiveness and quality of these medications [1] Group 1: Differences Between Generic and Original Drugs - Patients are increasingly accepting domestic generic drugs, but some still prefer original drugs, especially in critical situations [2] - Differences in drug absorption and effectiveness are attributed to individual body responses and the physical characteristics of the drugs, such as different crystal forms [2] - Variations in manufacturing processes and excipients used by generic drug manufacturers can lead to differences in taste and efficacy compared to original drugs [3] Group 2: Regulatory and Quality Standards - China has a high proportion of generic drugs, with over 95% of approved chemical drugs being generics [4] - The implementation of consistency evaluation standards has improved the quality of generic drugs, allowing them to compete more effectively with original drugs [5] - The consistency evaluation is seen as a starting point for ensuring drug quality, with ongoing monitoring necessary to prevent it from becoming a one-time assessment [6] Group 3: Challenges in Quality Assurance - Some manufacturers may alter packaging or excipients post-evaluation to reduce costs, which could impact drug quality and efficacy [6] - There are concerns about the validity of stability studies when extending the shelf life of generic drugs, as some may not follow proper protocols [7] - Regulatory bodies are enhancing oversight to ensure that the quality and efficacy of generic drugs remain consistent with original drugs [7]