Building Trust in Generics and Biosimilar: Strengthening Regulatory Confidence
Mohammad Sharif Abu Hassan, Farshila Emran, Sharifah Fauziyah Syed Mohthar, Roziana Ab Rahim, Amielia Ab Hamid · 2025
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Description
Mohammad Sharif Abu Hassan and co-authors make the case that Malaysia's drug regulators have earned trust in cheaper medicines, in a 2025 article. Generic drugs and biosimilars widen access, especially in poorer countries, yet patients and doctors often suspect them of being weaker copies. The authors describe the Malaysian system: the national regulator demands bioequivalence testing where the measured difference from the original drug averages only about three and a half percent.
Manufacturing audits, post-marketing surveillance, and registration standards reinforce the testing. A private regulatory services firm is presented as part of the ecosystem upholding those standards, from product registration to safety monitoring and training. The article argues that confidence is a regulatory product in its own right: when the checking is visibly strict, affordable medicines stop looking like second-class ones.
Catalog record
| CREATOR | Mohammad Sharif Abu Hassan, Farshila Emran, Sharifah Fauziyah Syed Mohthar, Roziana Ab Rahim, Amielia Ab Hamid |
|---|---|
| YEAR | 2025 |
| COLLECTION | PAPERS |
| FORMAT | TXT |
| FILE SIZE | 11 KB |
| VERSION | 1.0 |
| LICENSE | CC BY 4.0 |
| RIGHTS | CC BY |
| SOURCE | Europe PMC |