MANILA, Philippines?A study presented during last year?s 12th meeting on Recent Developments in Pharmaceutical Analysis (www.rdpa2007.com) held in Italy painted an alarming picture of generic drugs?the existence of those that do not measure up to the innovator product that they are supposed to duplicate.

The drug in question is docetaxel, which is a first line drug in the treatment of early-stage breast cancer, for someone who have just had, or soon will have, surgery to remove one or more invasive tumors from the breast and also for those with hormone-resistant prostate cancer.

The study analyzed 31 docetaxel formulations produced from 14 countries and compared it to Taxotere (Sanofi-Aventis), the innovator product that these generic drugs duplicated.

Results of the said study were published in a special symposium issue of the Journal of Pharmaceutical and Biomedical Analysis.

Identical

?A generic drug should not only be more affordable but it should also be identical to the innovator product it duplicated. It is supposed to be taken in the same manner as the innovator product, in other words, similar dosage, similar time duration, similar strength and similar instructions,? explained Dr. Antonio Villalon, professor of oncology, University of the Philippines-Philippine General Hospital.

He explained that if the generic drug is found to have an insufficient quantity of the active ingredient and has substantial amount of impurities not present in the innovator product, then doctors will be likened to prescribing an untested drug and will not be confident if it will be as effective and as safe.

?Cancer is a very serious disease and in its treatment, doctors follow a detailed plan of medical treatment or procedure, which is often based on clinical trials that employed the innovator product. This means if a doctor will use the generic drug, he or she must be sure it will exhibit the same efficacy and safety,? Villalon reminded.

Conventions

Villalon said that through international and local conventions as well as peer-reviewed journals, doctors are able to learn trends as well as be updated on issues regarding their field of expertise.

?These become one of their bases when examining and choosing what particular treatment to give their patients,? he added.

Villalon said that since Taxotere has been shown from various trials to significantly improve the survival rate of women with breast cancer and at the same time reduce their risk of relapse while giving them less severe side effects as compared with other therapy, its generic counterparts should exhibit the same performance.

?This is why it is important for the Bureau of Food and Drugs to ensure that the generic drugs that are available here are equally safe and effective. On the part of the doctors, they should always be updated and always on the lookout for studies, findings or researches being published since their decision will have a significant impact on their patients,? Villalon reminded.