19.11.08

Masterpiece & Others

Original Pharmaceuticals vs Generics

From FDA: 9 Steps Before Saying The Same

The everlasting "Me Too" message of generics usually tries to hammer the meaning of equivalence to original brand. But are they really the same? FDA had specified 9 steps to undertake before saying a generic product is equivalent to the original. These are:
  • In-vivo Bioequivalence Tests
    1.CMAX
    (the maximum concentration of the active ingredient reached in patients blood stream) should be within 90% of the pioneer
    2.CAVG (the average concentration of active ingredient reached in patients' blood stream) should be within 90% of the pioneer
    3.TMAX testing (The time after dosing when Cmax concentration occurs) within 80-125% of the pioneer.
    4.TLAG testing (The lag time before active ingredient appears in plasma)
    5.AUC should be within 80-125% of the pioneer. AUC is the area under the plot of plasma concentration of drug (not logarithm of the concentration) against time after drug administration. The area is conveniently determined by the "trapezoidal rule": the data points are connected by straight line segments, perpendiculars are erected from the abscissa to each data point, and the sum of the areas of the triangles and trapezoids so constructed is computed. When the last measured concentration (Cn, at time tn) is not zero, the AUC from tn to infinite time is estimated by Cn/kel.
  • Therapeutic Equivalence
    6.Active ingredient's purity: As degree of purity varies greatly according to source of the raw materials.
    7.Route efficiency testing: To determine the pharmacokinetics of the generic against the pioneer.
    8.Dose scaling: to determine the efficient dose compared to the pioneer brand
    9.Stability testing: Under the recommended conditions
The question now is, How many of the generics in the Egyptian market pass through these steps efficiently?

Why Cheaper? Sources of Price Difference in Generics
From the headquarters of generics itself, the Generic Pharmaceutical Association, wherein they should be defending the ideology of generics, we got their own claims justifying the price difference between a generic and the originator product.
On their official website: http://www.gphaonline.org/ they stated the reasons are;
  1. No R& D cost
  2. No regulatory approval costs
  3. Cheaper chemicals sourcing
  4. Reduced manufacturing costs sometimes with toll manufacturing.
  5. Lower marketing costs

Now, let us analyze these claims to reveal its real meanings

  • No. R& D cost = No ability for product performance monitoring, no chance for product development.
  • No regulatory approval cost = No bioavailability testing, no therapeutic equivalence testing.
  • Cheaper chemicals sourcing = Low purity active ingredients, low quality carriers and adjuvant à less bio-availability / less stability
  • Toll-manufacturing with reduced manufacturing costs = No GMP guidelines, No standardized procedure, poor quality control & poor quality assurance.
  • Lower marketing costs = Lower participation in educational activities, charitable activities & CVME

Copyrights© 2007. Eyad Harfoush

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