Ensuring safe, quality drugs with bioequivalent generics

MANILA, Philippines - High costs of medicine have long impeded many Filipinos from timely and quality healthcare. A solution comes in the form of generics, which are medicine developed from the same active ingredients of their branded counterparts offering similarly safe and potent cure — only cheaper.

Generic drugs have the same dosage, intended use, effects, side effects, route of administration, risks, safety, and strength as the original branded drug.

They are sold inexpensively because the manufacturers have not had the expenses spent by brand-name companies in the research, development, and marketing of a new drug.

Already, generic medicines have gained a foothold in the markets around the world. In the United States, as much as 40 percent of the public prefers the same generic drug counterparts.

In the Philippines, laws like the Generic Drug Act of 1986 have been implemented, making the Philippines the first Asian country to enact a Generics Law.

However, many consumers still hesitate to purchase generic alternatives; it has been reported that only 10 to 15 percent of Filipinos purchase the lower-priced unbranded drugs.

Aside from loyalty of consumers to branded drugs, the problem is also rooted on the notions that cheaper prices translate to lower pharmaceutical potency and that generic drugs are manufactured by substandard factories.

Bioequivalence (BE) tests assure that generic products have the same premium quality as the original and perform in the same — and safe — manner as the pioneer drug.

BE tests ensure identical composition, safety and strength between generic drugs and their branded originals.

These tests also look at similarities in the performance levels of the generic with the original. The US Food and Drug Administration (FDA) determines BE the same way.

BE tests also scrutinize if a generic drug conforms to country-specific regulatory standards. Bioequivalent drugs should have passed clinical trials from contract research organizations (CROs), which are independent private companies.

In general, BE tests guarantee quality generics for quality-conscious Filipinos. Xeno Pharmaceutical Philippines Inc. shares the same goal with its broad range of bioequivalent offerings.

“Xeno products are tested for bioequivalence in world-class scientific laboratories (BE Centers),” said Amado Tadena, Xeno chairman and CEO.

The bioequivalence assurance of products carried by Xeno Pharmaceuticals comes from three reputable laboratories that are compliant to regulatory requirements of the US-FDA.

These are clinical research services Reliance (Newton Pennsylvania and India), Sipra Laboratories, and BioSRL, a full service clinical research organization that conducts bioavailability and bioequivalence testing.

“The manufacturing facilities we use have been certified for product excellence, using state-of-the-art technology and global standards for quality assurance,” adds Tadena.

In addition, the premium products from Xeno are manufactured from facilities approved by three globally acknowledged institutions: US-FDA; the United Kingdom Medicines and Healthcare Products Regulatory Agency, an executive agency of the UK Department of Health; and World Health Organization’s Good Manufacturing Practice, which assures that a manufacturer’s facilities practice quality standard control and products.