Un générique de l’imatinib est développé en Amérique du Sud
Background: Imatinib is a tyrosine kinase inhibitor that has been established as a highly effective therapy for chronic myelogenous leukemia and gastrointestinal stromal tumors. A new generic, once-daily 400-mg tablet of imatinib has been developed by a pharmaceutical company in Argentina, where the regulatory standard for marketing authorization of an imatinib generic is in vitro dissolution testing.
http://cat.inist.fr/?aModele=afficheN&cpsidt=22136914
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cousineg
- Messages : 1058
- Enregistré le : lun. août 14, 2006 4:36 am
- Localisation : Montréal (Ar. Saint-Laurent)
-
cousineg
- Messages : 1058
- Enregistré le : lun. août 14, 2006 4:36 am
- Localisation : Montréal (Ar. Saint-Laurent)
Re: Les génériques de l'imatinib à travers le monde
Des génériques de l’imatinib sont développés en Inde. En voici quelques-uns:
La compagnie Sun Pharma vend l’imatinib sous le nom commercial ‘Imalek'
La compagnie Cipla vend l’imatinib sous le nom commercial ‘Imatib’.
La compagnie Natco vend l’imatinib sous le nom commercial ‘Veenat’
La compagnie Ranbaxy Laboratories Ltd vend l’imatinib sous le nom commercial ‘Zoleta’
Autres liens:
Failure of a non-authorized copy product to maintain response achieved with imatinib in a patient with chronic phase chronic myeloid leukemia: a case report
A 50-year-old woman presented with CML-CP and was initially treated with branded imatinib (Glivec®) 400 mg/day. She rapidly achieved a complete hematologic response (CHR), at which point she switched therapy to a copy version of imatinib (Imatib). She received 400 mg/day of Imatib for 3 months, during which time her platelet count decreased from 250 × 109 to 105 × 109/L and her hemoglobin count fell from 12.8 to 11 g/dL. The patient’s total leukocyte count rose rapidly from 4 × 109 to 70 × 109/L, and the CHR was lost. At this point, therapy was switched back to Glivec at 400 mg/day, and the CHR was rapidly regained. Furthermore, the patient achieved a major cytogenetic response by 6 months after reintroduction of Glivec. This case report suggests a difference in clinical efficacy between the authorized form of imatinib (Glivec) and the copy version of the drug (Imatib). The exact reasons for the observed difference in clinical efficacy are unknown, but likely relate to the use of alternative polymorphic forms of the drug. Glivec can be obtained directly from the manufacturer (Novartis Pharmaceuticals) through a variety of patient access programs that should be fully explored when needed.
Extrait de http://www.springerlink.com/content/x33820867g150117/
Compte-rendu sur les génériques de l'imatinib dans le monde
''Generic Gleevec is not FDA approved and will not be until the patent on gleevec expires in 2015''
Extrait de http://gistsupport.medshelf.org/Generic_Gleevec
La compagnie Sun Pharma vend l’imatinib sous le nom commercial ‘Imalek'
La compagnie Cipla vend l’imatinib sous le nom commercial ‘Imatib’.
La compagnie Natco vend l’imatinib sous le nom commercial ‘Veenat’
La compagnie Ranbaxy Laboratories Ltd vend l’imatinib sous le nom commercial ‘Zoleta’
Autres liens:
Failure of a non-authorized copy product to maintain response achieved with imatinib in a patient with chronic phase chronic myeloid leukemia: a case report
A 50-year-old woman presented with CML-CP and was initially treated with branded imatinib (Glivec®) 400 mg/day. She rapidly achieved a complete hematologic response (CHR), at which point she switched therapy to a copy version of imatinib (Imatib). She received 400 mg/day of Imatib for 3 months, during which time her platelet count decreased from 250 × 109 to 105 × 109/L and her hemoglobin count fell from 12.8 to 11 g/dL. The patient’s total leukocyte count rose rapidly from 4 × 109 to 70 × 109/L, and the CHR was lost. At this point, therapy was switched back to Glivec at 400 mg/day, and the CHR was rapidly regained. Furthermore, the patient achieved a major cytogenetic response by 6 months after reintroduction of Glivec. This case report suggests a difference in clinical efficacy between the authorized form of imatinib (Glivec) and the copy version of the drug (Imatib). The exact reasons for the observed difference in clinical efficacy are unknown, but likely relate to the use of alternative polymorphic forms of the drug. Glivec can be obtained directly from the manufacturer (Novartis Pharmaceuticals) through a variety of patient access programs that should be fully explored when needed.
Extrait de http://www.springerlink.com/content/x33820867g150117/
Compte-rendu sur les génériques de l'imatinib dans le monde
''Generic Gleevec is not FDA approved and will not be until the patent on gleevec expires in 2015''
Extrait de http://gistsupport.medshelf.org/Generic_Gleevec