Summary of studies evaluating the outcomes of generics after switching from the original molecule
| Authors . | Country . | Sample size, n . | Line of treatment (switched from branded IM/frontline) . | Median duration of branded IM before switch, years (range) . | Response level at the time of switch . | Median follow-up duration after switch, mo (range) . | Molecular response after switch (%) . | New or worsening adverse events at all grades after switch . | Name of generic and/or manufacturer . | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CCyR (%) . | ≥MMR (%) . | Stable . | Improved . | Worsened . | ||||||||
| Alwan et al9 | Iraq | Generics: 126 | Switched | 4 (0.5-7) | NR | NR | ≥9* | NR | NR | NR | NR | Imatib (Cipla) |
| Eskazan et al20 | Turkey | Generics: 80; Branded IM: 65 | Switched (n: 76) Frontline (n: 4) | ∼5 | 100 | 77 | 12 (4-16) | 83.75 | 8.75 | 7.5 | NR | Imatis (Deva): ● n = 63 (switched) ● n = 2 (frontline) Imatenil (Logus) ● n = 13 (switched) Imavec (Koçak) ● n = 2 (frontline) |
| Bonifacio et al21 | Italy | Generics: 294 | Switched | 7.4 (0.5-16.7) | NR | 92 | 7.5 (0-12.2) | 61 | 25 | 14 | 17% | Imatinib Sandoz |
| Lejniece et al22 | Latvia | Generics: 25 | Switched | ≥ 2 | NR | 100 | 24 | 100 | 0 | 0 | NR | Tibaldix Meaxin Imatinib Teva Itivas Imatinib Accord Imatinib Sano Swiss |
| Abou Dalle et al23 | United States | Generics: 38 | Switched | 2 (1.5-17) | 100 | 95 | 19.4 (3.4-46.3) | 89 | 8 | 3 | 39% | Sun Pharmaceuticals Apetex Teva Mylan |
| Scalzulli et al24 | Italy | Generics: 168 | Switched | 12 (1-16) | 100 | 100 | 19 (4-22) | 84 | 6 | 10 | 20% (15% ≥grade 3) | Imatinib Accord |
| Gemelli et al25 | Italy | Generics: 200 | Switched | 8.9 (3-17.4) | 100 | 100 | 20 | 69 | 25.5 | 5.5 | NR† | Accord (n = 117) Sandoz (n = 41) Teva (n = 109) Dr. Reddy (n = 1) Mylan (n = 1) |
| Authors . | Country . | Sample size, n . | Line of treatment (switched from branded IM/frontline) . | Median duration of branded IM before switch, years (range) . | Response level at the time of switch . | Median follow-up duration after switch, mo (range) . | Molecular response after switch (%) . | New or worsening adverse events at all grades after switch . | Name of generic and/or manufacturer . | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| CCyR (%) . | ≥MMR (%) . | Stable . | Improved . | Worsened . | ||||||||
| Alwan et al9 | Iraq | Generics: 126 | Switched | 4 (0.5-7) | NR | NR | ≥9* | NR | NR | NR | NR | Imatib (Cipla) |
| Eskazan et al20 | Turkey | Generics: 80; Branded IM: 65 | Switched (n: 76) Frontline (n: 4) | ∼5 | 100 | 77 | 12 (4-16) | 83.75 | 8.75 | 7.5 | NR | Imatis (Deva): ● n = 63 (switched) ● n = 2 (frontline) Imatenil (Logus) ● n = 13 (switched) Imavec (Koçak) ● n = 2 (frontline) |
| Bonifacio et al21 | Italy | Generics: 294 | Switched | 7.4 (0.5-16.7) | NR | 92 | 7.5 (0-12.2) | 61 | 25 | 14 | 17% | Imatinib Sandoz |
| Lejniece et al22 | Latvia | Generics: 25 | Switched | ≥ 2 | NR | 100 | 24 | 100 | 0 | 0 | NR | Tibaldix Meaxin Imatinib Teva Itivas Imatinib Accord Imatinib Sano Swiss |
| Abou Dalle et al23 | United States | Generics: 38 | Switched | 2 (1.5-17) | 100 | 95 | 19.4 (3.4-46.3) | 89 | 8 | 3 | 39% | Sun Pharmaceuticals Apetex Teva Mylan |
| Scalzulli et al24 | Italy | Generics: 168 | Switched | 12 (1-16) | 100 | 100 | 19 (4-22) | 84 | 6 | 10 | 20% (15% ≥grade 3) | Imatinib Accord |
| Gemelli et al25 | Italy | Generics: 200 | Switched | 8.9 (3-17.4) | 100 | 100 | 20 | 69 | 25.5 | 5.5 | NR† | Accord (n = 117) Sandoz (n = 41) Teva (n = 109) Dr. Reddy (n = 1) Mylan (n = 1) |
IM, imatinib; NA, not available; NR, not reported.
Patients switched back to branded imatinib after at least 9 months of generic use but exact median duration under generic is not reported.
Fatigue, muscle cramps, myalgia, edema of limbs and periorbital area, diarrhea, and rash were significantly lower with generics.