fo - june 2014 venofer new anti generic presentation
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venofer by RG companyTRANSCRIPT
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Myth and Reality
ISS Claims of Venofer® equivalency.
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Latest development
Comparison of Oxidative Stress and Inflammation Induced by Different Intravenous Iron Sucrose
Similar (ISS) Preparations in a Rat Model1.
• Physico-chemical analyses showed that the molecular structure of most of the ISSs differed greatly from that of the ISORIG.
• These differences may be responsible for the organ damage and oxidative stress observed in the ISS groups.
1. Inflammation & Allergy - Drug Targets, 2012, 11, 66-78
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1.Venofer®, Vifor (International), Switzerland2. ISSFERP (Ferplex® SS, Himont Pharmaceuticals, Lahore, Pakistan),3. ISSFERI (Ferijet, Akson Pharmaceuticals, Azad Kashmir, Pakistan),4. ISSFERO (Ferosoft® S, Hilton Pharma Ltd., Karachi, Pakistan),
The real difference …
1. Inflammation & Allergy - Drug Targets, 2012, 11, 66-78
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The Study Conclusion:
1. Inflammation & Allergy - Drug Targets, 2012, 11, 66-78
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Current Medical Research & Opinion 2012
“ISSs differ from the iron sucrose originator in safety and efficacy profiles”.
Current Medical Research & Opinion Vol. 28, No. 2, 2012, 241–243
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Importance of Therapeutic equivalency
• Administration of 200mg of Venofer results in increase in hemoglobin equivalent to 1gm/dl.
• Equivalent amount i.e. 200mg of ISS do not gives the same results.
Q. Where the rest of the iron goes?
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Venofer® - The Global brand
• 36 generic copies of Venofer® in Pakistan• Few copies in India.• 2 Copies in Taiwan
• Venofer Price in US - $68 per injection• No copy of Venofer in US till to date, (12 years)
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FDA – Guideline for Iron sucrose Generics:
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Thank you