There are innovator molecules and there are generic alternatives. The innovator is the original molecule developed by the company that discovered it. Upon expiration of its patent, the generic alternatives come in. Over the years we have developed a certain level of trust in using the original brand because the companies that market these have provided us with clinical data on efficacy and safety for its indicated treatment. We cannot say the same for all generic alternatives.

There are several ways of defining generic drugs based in the following:

•	Pharmaceutical equivalents contain the same active ingredient(s), have the same dosage form and route of administration, and are identical in strength or concentration. Equivalent products contain the same amount of ingredient in the same dosage form but may differ in characteristics, such as shape, release mechanisms, and packaging.
•	Pharmaceutical alternatives contain the same therapeutic moiety but have different salts, esters, or complexes of the same moiety, of different dosage forms, or of different strengths.
•	Therapeutic equivalents are expected to have the same clinical effect and safety profile as the innovator brand.” Under therapeutic equivalents are the following:
		• Pharmaceutical equivalents • Bioequivalent • Approved as safe and effective • Adequately labeled • Manufactured in compliance with current Good Manufacturing Practice (GMP) regulations

Concept of bioavailability and bioequivalence. • Bioavailability (BA) is the rate and extent to which the active ingredient in pharmaceutical equivalents becomes available at the site of drug action. • Bioequivalence (BE) means that there are no significant differences between pharmaceutical equivalents in rate and extent of absorption when administered to patients or subjects at the same molar dose under similar experimental conditions. In other words, product B should be equal to product A in its pharmacokinetic profile in order for product B to claim the same therapeutic effect.” (See FDA Requirements on Bioequivalence below)

Bioequivalence studies have three (3) parameters. • AUC or Area Under the Concentration-Time Curve • Cmax of the maximum plasma concentration. • Tmax or the time to maximum concentration

Not all drugs of the same generic have the same pharmacokinetic profile.

As the innovator of a research-based product Cilostazol (Pletaal), Otsuka Philippines Pharmaceutical, Inc. in cooperation of the UST Center for Drug Research Evaluation and Studies, Inc. (CeDRES), (BFAD-accredited drug research center) a bioequivalence study was conducted to compare and evaluate the bioavailability of the generic drug Cilostazol 100mg versus the innovator drug product Cilostazol 100mg following a single dose administration.

The protocol of the BE study was approved by the Institutional Review Board of UST CeDRES on February 6, 2008.

Figure 1. Plots of mean plasma concentration-time curves of test (A) and reference (B) drug products	Figure 2. Logarithmic plots of mean plasma concentation-time curves of test (A) and reference (B) drug products.

The above data (Figure 1.) showed that the test product (Clazol 100mg tablet) is not comparable to that of the reference product (Pletaal 100mg tablet) because the test drug is suprabioavailable compared to the reference drug. There was too much drug than was required giving the test drug a questionable safety profile.

Dr. William Torres, President of UST CeDRES and Head Investigator of the study concluded that the generic test drug Cilostazol Clazol 100 mg tablet is not bioequivalent to the reference/innovator drug product, Pletaal 100mg.

True enough, “not all Cilostazols are the same”, based on this credible study the innovator is still the tried and tested brand of Cilostazol.

As healthcare partners, Otsuka Philippines Pharmaceutical Inc. only wants safe, effective and quality medicines for our patients.

We create products based on evidence of safety, efficacy and finest quality.

“The most expensive medicine is the one that does not work.”

Download CILOSTAZOL BE Summary Report>>