Myth and Reality

ISS Claims of Venofer® equivalency.

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

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

The Study Conclusion:

1. Inflammation & Allergy - Drug Targets, 2012, 11, 66-78

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

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?

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)

FDA – Guideline for Iron sucrose Generics:

Thank you