Generic Medicine: is it really a copy cat?

When it comes to healthcare we do not want to take risks. We want only the best for our families and ourselves. We may not have considered using a generic medicine because we may be concerned that it is just a copy cat. But how does this copy cat compare to its original brand?

What is Generic Medicine?
All medicines have two names:
Generic name
Brand name

The generic name refers to the active ingredient of the medicine. The manufacturer chooses a brand name that can be recognized, pronounced and remembered by everyone. For example, Zocor® is Merck Sharp & Dohme’s brand name for simvastatin, a generic name.
When a medicine is first developed, it is patented and sold exclusively under a single brand name. This is known as the innovator product. After the patent period expires, generic manufacturers may legally ‘copy’ the same active ingredient and give it a different
brand name. Generic medicines are made to be interchangeable with the innovator product. It contains the same active ingredient but usually contain different amounts of inactive ingredients known as excipients. Occasionally it differs from the innovator product in size, shape or colour. For instance, in Malaysia and Singapore, there are at least 8 brands (generics) competing with the innovator painkiller Voltaren®, all of which contain diclofenac sodium.

Why are Generic Medicines cheaper?
An innovator drug company spends a large sum of money (about US $500 to $600 million) on research and development of a new medicine, performing tests in the laboratory, on animals and humans, and obtaining approval for the medicine to be marketed. The high costs involved explain the high pricing aimed at reaping profits on the initial investment. Conversely, a generic manufacturer need not incur these costs. Therefore, a generic medicine is generally 30 to 60% cheaper than its innovator counterpart.

What about the quality of Generic Medicines?
To be assured of good quality medicine, it is important to check that it is registered with the regulatory authority. The Malaysian Drug Control Authority (DCA) gives registration numbers with MAL followed by 8 numerical digits. Singapore’s Health Science Authority (HSA) registers products with the code SIN followed by 5 numerical digits. DCA and HSA register only products
manufactured under Good Manufacturing Practice (GMP) environment. Periodic audits are performed on these companies to ensure strict compliance to the highest quality.
In vitro (laboratory) tests are performed according to international standards such as the British Pharmacopoeia (BP) and United States Pharmacopoeia (USP). The in vitro tests will show if a particular generic medicine:
• contains the correct amount of active ingredient
• contains excessive impurities and other related substances
• is uniform in size, shape and weight
• has appropriate hardness
• is not friable
• disintegrates and dissolves within a stipulated time frame
• is stable until its expiry date
However, some of us may have experiences whereby only the innovator brand works, not the generic brand. This could be because of our own bias towards generics or the generic is truly of inferior quality compared to the innovator; a condition known as nonbioequivalence.
So many brands – spoilt for choices!
Faced with so many brands for a particular medicine, a simple step is to ask your Pharmacist or Doctor for a professional opinion.
We should constantly exercise our consumer rights to know what we are buying or receiving. We can ask, “Is the product registered?”
If it is a generic, “Is it bioequivalent to the innovator?”
Take responsibility for you and your family’s health. Be an active partner with your healthcare professional in managing your medication needs. The first step in taking responsibility is to raise awareness and increase knowledge – so, congratulations for taking that first step – by reading this article!