Temporal Trends in the Prescription of Biosimilars and the Status of Switching from Original Biologics to Biosimilars at Individual and Institutional Levels in Japan

Abstract

Purpose: To describe the temporal trends in the prescription of biologics in Japan, with additional analysis focusing on switching from original biologics to biosimilars at the individual and institutional levels.

Methods: Using the JMDC claims database from January 2005 to May 2024, we identified patients who received at least one prescription for 17 biologics (original biologics or biosimilars). We elucidated the monthly trends in the proportions of original biologics and biosimilars. We also estimated the proportion of patients receiving original biologics only, those receiving biosimilars only, and those switching from original biologics to biosimilars (and vice versa) during the study period. Finally, we estimated the proportion of medical institutions that started prescribing biosimilars during the study period based on the type of medical institution.

Results: Temporal trends in the proportions of original biologics and biosimilars varied widely. In May 2024, the proportion of biosimilar prescriptions was 13.6% for somatropin and 92.5% for filgrastim. At the individual level, the proportion of patients switching from original biologics to biosimilars was low (1.2-14.0%), indicating that switches do not often occur within the same patient, while more recent new users of biologics start biosimilars. At the institutional level, university-related hospitals and clinics were more and less likely, respectively to introduce biosimilars than public and other types of hospitals.

Conclusion: Temporal trends in the prescription of biosimilars and switching patterns varied widely by the type of biologics. The type of medical institution should be considered when assessing and promoting the use of biosimilars. Further research and strategies to increase the use of biosimilars in clinics may be needed.

Keywords: Administrative claims; Biological products; Biosimilar pharmaceuticals; Drug utilization; Pharmacoepidemiology.

Figure 1

Monthly trend in the proportion of prescriptions of original biologics (colored gray) or biosimilars (colored black) among the total prescriptions for each biologic during the study period. Although all original biologics or biosimilars available in Japan were included in the main analysis, the sensitivity analysis made the following changes (Supplementary Table S1): For somatropin, we considered Genotropin vs. Somatropin BS. For erythropoietin, we considered Espo vs. Epoetin Alfa BS (Epoetin Kappa). For insulin glargine, we considered Lantus (not including Lantus XR) vs. Insulin Glargine BS. For darbepoetin alfa, we considered Nesp vs. Darbepoetin Alfa BS (not including Darbepoetin Alfa authorized generic). For insulin lispro, we considered Humalog (not including Humalog Mix and Humalog N) vs. Insulin Lispro BS. For insulin aspart, we considered NovoRapid (not including NovoRapid Mix) vs. Insulin Aspart BS.

Figure 1

Monthly trend in the proportion of prescriptions of original biologics (colored gray) or biosimilars (colored black) among the total prescriptions for each biologic during the study period. Although all original biologics or biosimilars available in Japan were included in the main analysis, the sensitivity analysis made the following changes (Supplementary Table S1): For somatropin, we considered Genotropin vs. Somatropin BS. For erythropoietin, we considered Espo vs. Epoetin Alfa BS (Epoetin Kappa). For insulin glargine, we considered Lantus (not including Lantus XR) vs. Insulin Glargine BS. For darbepoetin alfa, we considered Nesp vs. Darbepoetin Alfa BS (not including Darbepoetin Alfa authorized generic). For insulin lispro, we considered Humalog (not including Humalog Mix and Humalog N) vs. Insulin Lispro BS. For insulin aspart, we considered NovoRapid (not including NovoRapid Mix) vs. Insulin Aspart BS.

Figure 2

Distribution of patients receiving only original biologics or biosimilars during the study period or switchers. For switchers, only the first switch was assessed and counted (i.e., some patients switched twice or more). Although all original biologics or biosimilars available in Japan were included in the main analysis, the sensitivity analysis made the following changes (Supplementary Table S1): For somatropin, we considered Genotropin vs. Somatropin BS. For erythropoietin, we considered Espo vs. Epoetin Alfa BS (Epoetin Kappa). For insulin glargine, we considered Lantus (not including Lantus XR) vs. Insulin Glargine BS. For darbepoetin alfa, we considered Nesp vs. Darbepoetin Alfa BS (not including Darbepoetin Alfa authorized generic). For insulin lispro, we considered Humalog (not including Humalog Mix and Humalog N) vs. Insulin Lispro BS. For insulin aspart, we considered NovoRapid (not including NovoRapid Mix) vs. Insulin Aspart BS.

Figure 3

Distribution of medical institutions prescribing only original biologics (colored gray) or original biologics and biosimilars (colored black) during the study period. Although all original biologics or biosimilars available in Japan were included in the main analysis, the sensitivity analysis made the following changes (Supplementary Table S1): For somatropin, we considered Genotropin vs. Somatropin BS. For erythropoietin, we considered Espo vs. Epoetin Alfa BS (Epoetin Kappa). For insulin glargine, we considered Lantus (not including Lantus XR) vs. Insulin Glargine BS. For darbepoetin alfa, we considered Nesp vs. Darbepoetin Alfa BS (not including Darbepoetin Alfa authorized generic). For insulin lispro, we considered Humalog (not including Humalog Mix and Humalog N) vs. Insulin Lispro BS. For insulin aspart, we considered NovoRapid (not including NovoRapid Mix) vs. Insulin Aspart BS.

Figure 3

Distribution of medical institutions prescribing only original biologics (colored gray) or original biologics and biosimilars (colored black) during the study period. Although all original biologics or biosimilars available in Japan were included in the main analysis, the sensitivity analysis made the following changes (Supplementary Table S1): For somatropin, we considered Genotropin vs. Somatropin BS. For erythropoietin, we considered Espo vs. Epoetin Alfa BS (Epoetin Kappa). For insulin glargine, we considered Lantus (not including Lantus XR) vs. Insulin Glargine BS. For darbepoetin alfa, we considered Nesp vs. Darbepoetin Alfa BS (not including Darbepoetin Alfa authorized generic). For insulin lispro, we considered Humalog (not including Humalog Mix and Humalog N) vs. Insulin Lispro BS. For insulin aspart, we considered NovoRapid (not including NovoRapid Mix) vs. Insulin Aspart BS.