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- Title
Drug Lag for Biosimilar Medicines in Malaysia: A Kaplan-Meier Survival Analysis.
- Authors
My Hoang Nguyen Thao; Omotayo Fatokun; Farrukh, Muhammad Junaid
- Abstract
The availability of biosimilar medicines increases access to biological therapies at potentially lower costs. However, drug lag, defined as the delay between the global first approval and the approval from the national regulatory authority in each country, can minimise the cost-saving benefit of biosimilar medicines. This study assesses the drug lag from the first approval of a biosimilar medicine in Europe to the first approval of the corresponding biosimilar medicine in Malaysia as of December 31, 2022, and examines the difference in drug lag between the biosimilar medicines based on biological classification. The list of approved biosimilar medicines by their international non-proprietary names (INN) with their approval dates in Europe as of July 1, 2022, was obtained from the literature and the drug approval database of the European Medicines Agency. Data on approved biosimilar medicines (INN) in Malaysia was obtained from the approved biosimilar medicine database of the Malaysian national pharmaceutical regulatory authority. Drug lag (in median time) was assess using Kaplan-Meier survival analysis. The difference in drug lag between the biosimilar medicines based on biological classification was assess using the log-rank test. Statistically significant level was set at p < 0.05. All analyses were conducted using IBM SPSS version 25. A total of 18 biosimilar medicines (INN) were first approved in Europe as of July 1, 2022, of which 15 (83.3%) were approved in Malaysia as of December 31, 2022. The drug lag to the first approval of biosimilar medicine in Malaysia was 1572 days (95% CI = 503.25 - 2640.75). The log-rank test shows there was a statistically significant difference in drug lag between monoclonal antibody biological products (506 days) and nonmonoclonal antibody biological products (2161) days, X2(1) = 11.924, p = 0.001. On average, it took about 52 months for a biosimilar medicine to be approved in Malaysia after it was first approved in the global market. Monoclonal antibody biosimilar medicines experienced a significantly shorter drug lag compared to non-monoclonal antibody biosimilar medicines. Further research can examine the factors associated with drug lag for biosimilar medicines and the impact on access to biological therapies in Malaysia.
- Subjects
MALAYSIA; BIOSIMILARS; SURVIVAL analysis (Biometry); MONOCLONAL antibodies; BIOLOGICAL classification; MEDICAL databases; LOG-rank test
- Publication
Current Trends in Biotechnology & Pharmacy, 2023, Vol 17, p96
- ISSN
0973-8916
- Publication type
Article