Generic Drugs

Generic drugs are copies of brand-name drugs that have exactly the same dosage, intended use,
effects, side effects, route of administration, risks, safety, and strength as the original drug. In
other words, their pharmacological effects are exactly the same as those of their brand-name
counterparts.

An example of a generic drug, one used for diabetes, is metformin. A brand name for metformin
is Glucophage. (Brand names are usually capitalized while generic names are not.) A generic
drug, one used for hypertension, is metoprolol, whereas a brand name for the same drug
is Lopressor.

Many people become concerned because generic drugs are often substantially cheaper than the
brand-name versions. They wonder if the quality and effectiveness have been compromised to
make the less expensive products. The FDA (U.S. Food and Drug Administration) requires that
generic drugs be as safe and effective as brand-name drugs.

Actually, generic drugs are only cheaper because the manufacturers have not had the expenses of
developing and marketing a new drug. When a company brings a new drug onto the market, the
firm has already spent substantial money on research, development, marketing and promotion of
the drug. A patent is granted that gives the company that developed the drug an exclusive right to
sell the drug as long as the patent is in effect.

As the patent nears expiration, manufacturers can apply to the FDA for permission to make and
sell generic versions of the drug; and without the startup costs for development of the drug, other
companies can afford to make and sell it more cheaply. When multiple companies begin
producing and selling a drug, the competition among them can also drive the price down even
further.

So there's no truth in the myths that generic drugs are manufactured in poorer-quality facilities or
are inferior in quality to brand-name drugs. The FDA applies the same standards for all drug
manufacturing facilities, and many companies manufacture both brand-name and generic drugs.
In fact, the FDA estimates that 50% of generic drug production is by brand-name companies.
Another common misbelief is that generic drugs take longer to work. The FDA requires that
generic drugs work as fast and as effectively as the original brand-name products.

Sometimes, generic versions of a drug have different colors, flavors, or combinations of inactive
ingredients than the original medications. Trademark laws in the United States do not allow the
generic drugs to look exactly like the brand-name preparation, but the active ingredients must be
the same in both preparations, ensuring that both have the same medicinal effects. [ CITATION
Sto \l 13321 ]

A generic drug is a medication created to be the same as an already marketed brand-name drug
in dosage form, safety, strength, route of administration, quality, performance characteristics,
and intended use. These similarities help to demonstrate bioequivalence, which means that a
generic medicine works in the same way and provides the same clinical benefit as its brand-
name version. In other words, you can take a generic medicine as an equal substitute for its
brand-name counterpart.

Any generic medicine modeled after a brand-name medicine must perform the same in the body
as the brand-name medicine. This standard applies to all generic medicines. A generic medicine
is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and
quality, as well as in the way it is taken and the way it should be used. Generic medicines use the
same active ingredients as brand-name medicines and work the same way, so they have the same
risks and benefits as the brand-name medicines. The FDA Generic Drugs Program conducts a
rigorous review to make certain generic medicines meet these standards, in addition to
conducting 3,500 inspections of manufacturing plants a year and monitoring drug safety after the
generic medicine has been approved and brought to market.

It is important to note that there will always be a slight, but not medically important, level of
natural variability—just as there is for one batch of brand-name medicine compared with the
next batch of brand-name product. This variability can and does occur during manufacturing, for
both brand-name and generic medicines. When a medicine, generic or brand-name, is mass
produced, very small variations in purity, size, strength, and other parameters are permitted. FDA
limits how much variability is acceptable.
For example, in a very large research study1 comparing generics with brand-name medicines, it
was found that there were very small differences (approximately 3.5%) in absorption into the
body between generic and the brand-name medicines. Some generics were absorbed slightly
more, some slightly less. This amount of difference is expected and acceptable, whether for one
batch of brand-name medicine tested against another batch of the same brand, or for a generic
tested against a brand-name medicine. As a rule, the difference for the generic-to-brand
comparison was about the same as the brand-to-brand comparison.

Trademark laws in the United States do not allow a generic drug or medicine to look exactly like
other drugs already on the market. Generic medicines and brand-name medicines share the same
active ingredient, but other characteristics, such as colors and flavorings, that do not affect the
performance, safety, or effectiveness of the generic medicine, may be different.

Drug companies can submit an abbreviated new drug application (ANDA) for approval to
market a generic drug that is the same as (or bioequivalent to) the brand-name version. FDA's
Office of Generic Drugs reviews the application to make certain drug companies have
demonstrated that the generic medicine can be substituted for the brand-name medicine that it
copies.

An ANDA must show the generic medicine is equivalent to the brand in the following ways:

 The active ingredient is the same as that of the brand-name drug/innovator drug.
o An active ingredient in a medicine is the component that makes it
pharmaceutically active — effective against the illness or condition it is treating.

o Generic drug companies must provide evidence that shows that their active
ingredient is the same as that of the brand-name medicine they copy, and FDA must
review that evidence.

 The generic medicine is the same strength.

 The medicine is the same type of product (such as a tablet or an injectable).

 The medicine has the same route of administration (such as oral or topical).

 It has the same use indications.

 The inactive ingredients of the medicine are acceptable.
o Some differences, which must be shown to have no effect on how the medicine
functions, are allowed between the generic and the brand-name version.

o Generic drug companies must submit evidence that all the ingredients used in
their products are acceptable, and FDA must review that evidence.

 It lasts for at least the same amount of time.

o Most medicines break down, or deteriorate, over time.

o Generic drug companies must do months-long "stability tests" to show that their
versions last for at least the same amount of time as the brand-name.

 It is manufactured under the same strict standards as the brand-name medicine.

o It meets the same batch requirements for identity, strength, purity, and quality.

o The manufacturer is capable of making the medicine correctly and consistently.

 Generic drug manufacturers must explain how they intend to manufacture
the medicine and must provide evidence that each step of the manufacturing process
will produce the same result each time. FDA scientists review those procedures, and
FDA inspectors go to the generic drug manufacturer's facility to verify that the
manufacturer is capable of making the medicine consistently and to check that the
information the manufacturer has submitted to FDA is accurate.

 Often, different companies are involved (such as one company

manufacturing the active ingredient and another company manufacturing the finished
medicine). Generic drug manufacturers must produce batches of the medicines they
want to market and provide information about the manufacturing of those batches for
FDA to review.

 The container in which the medicine will be shipped and sold is appropriate.

 The label is the same as the brand-name medicine's label.

o The drug information label for the generic medicine should be the same as the
brand-name label. One exception is if the brand-name drug is approved for more than one
use and that use is protected by patents or exclusivities. A generic medicine can omit the
 protected use from its labeling and only be approved for a use that is not protected by
patents or exclusivities, so long as that removal does not take away information needed for
safe use. Labels for generic medicines can also contain certain changes when the drug is
manufactured by a different company, such as a different lot number or company name.

 Relevant patents or exclusivities are addressed.

o As an incentive to develop new medicines, drug companies are awarded patents
and exclusivities that may delay FDA approval of applications for generic medicines. FDA
must comply with the delays in approval that the patents and exclusivities impose.

The ANDA process does not, however, require the drug applicant to repeat costly animal and
clinical research on ingredients or dosage forms already approved for safety and effectiveness.
This allows generic medicines to be brought to market more quickly and at lower cost, allowing
for increased access to medications by the public. [ CITATION USF17 \l 13321 ]

When the pain reliever acetaminophen was developed in the 1950s, it was only available under its
brand name, Tylenol. Today, acetaminophen can be found in many generic and store-brand versions.
Similarly, many drug products, prescription and over-the-counter, have generic versions available.
An estimated 44 percent of all prescriptions in the United States are filled with generic drugs.

New drugs are developed by innovator firms. Patents protect these companies' investments by giving
them the sole right to sell the drug while the patents are in effect. When patents or other periods of
exclusive marketing for brand-name drugs are near expiration, manufacturers can apply to the Food
and Drug Administration to sell generic versions.

The law that allows approval of generic products, the Drug Price Competition and Patent Term
Restoration Act of 1984, builds in certain protections for the original drug developer (including
patents and marketing exclusivities), but also allows drug sponsors of identical products to apply for
FDA approval without repeating the original developer's clinical trials. The law also encourages
generic firms to challenge innovator patents by awarding marketing exclusivity to the first generic
version challenger.
Generic drugs are safe, effective and FDA-approved. According to Gary Buehler, M.D., director of
the FDA's Office of Generic Drugs, "People can use them with total confidence." [ CITATION Web
\l 13321 ]

Generic drugs in the Philippines.  Are they safe?  Are they really affordable? Are there better
options? Our impression is that the Philippine pharmaceutical industry manufactures few drugs.
Mostly it buys raw ingredients, or semi-finished products, repackages and markets them. The
vast majority of drug manufacturing for Asia (and the rest of the world)  is in India and China.
Increasingly U.S. pharmaceutical firms are farming-out their drug manufacturing to developing
countries, especially India.  Even the biggest, most established Indian drug makers have had
quality control problems. If they market in the U.S., their plants are to be inspected by the FDA.
The FDA found problems at Dr. Reddy, which is now owned by a Japanese drug company. It’s
probably the cream of the crop. Usually you have no idea where the generic drug in a Philippine
pharmacy actually comes from. I have never seen any generic drugs from the big established
generic firms such as Teva or Mylan.

Filipino physicians are themselves suspicious of generic drugs in the Philippines. A survey of
physicians showed that 70% are opposed to the 1988 generic drugs act.  Why?  A majority of
these physicians believe that the Philippine Bureau of Food and Drugs is not capable of ensuring
the quality of the generic drugs.  Filipinos also tend to buy brand name drugs.  It’s hard to know
if these suspicions are justified.  Pharmaceutical sales reps overrun the offices of Philippine
doctors, just as they do in the U.S.  Most of them are articulate, well groomed and attractive.  It
would be surprising if they did not encourage physicians to be suspicious of the generics which
are a threat to their employers and their own jobs.  This is a replay of what happened in the U.S.
in the early days of generics.

In our experience, Philippine physicians mostly seem uninterested in the affordability of the
drugs they prescribe.  Most specify expensive brand-name drugs.  We usually ask physicians
about the availability of generics.  Sometimes they seem surprised and disappointed with their
patient that they would stoop to use generics.  The the drug company brain washing seems to
work!
We have used Philippine generics for years.  We stick to buying them at Mercury or another
reputable pharmacy such as Rose or Watson’s.  Usually we buy United Labs or Pharex products.
These are the two biggest generic drug makers in the Philippines.  The drugs work as they
should.  We have had no problems.  But, Philippine generics are not inexpensive by world
standards. For example, Bob takes the drug Finasteride each day and will have to for the
remainder of his life.  A generic version costs $1.08 (USD) per pill at Mercury.  The same tablet
from a big Indian pharmaceutical company (Cipla) costs $.40.   Pfizer Atorvastatin (Lipitor –
made in Turkey) 40mg costs $1.17 at Mercury.  The Cipla product costs $.68 (plus postage)
at https://www.alldaychemist.com.
So, if they can afford it, expats and well-to-do Filipinos can stick with overpriced brand name
drugs at very high prices. We tend to shop at Mercury Drug or Watson (owned by a big Hong
Kong corporation) in the hope that they might exercise some judgment over the generics they
sell.  I read that a Mercury rep suggests that their generics are suitable for the middle classes —
that is those who can’t afford brand name drugs but who don’t feel comfortable with ordinary
generics. [ CITATION MyP12 \l 13321 ]

So how much exactly can you save? Here’s a comparative study I did on generic cholesterol
medicine and other similar products. Prices quoted are in Philippine Pesos.

CHOLESTEROL
Fenofibrate cap 200 mg: 17.00 vs 24.00
Simvastatin tab 20 mg: 1.50 vs 11.00

HYPERTENSION
Amlodipine tab 10 mg: 2.25 vs 4.70
Nifedipine cap 10 mg: 3.45 vs 9.90

ASTHMA
Salbutamol 100 mcg Inhaler: 129.25 vs 347.40

ARTHTRITIS / BODY PAIN

Naproxen cap 500 mg: 6.00 vs 15.00
NERVOUS SYSTEM
Fluoxetine cap 20 mg: 7.80 vs 32.25

DIABETES
Human Insulin 1 vial: 180.00 vs 280.00
Metformin tab 500 mg: 2.00 vs 5.30

[ CITATION Vil16 \l 13321 ]

References
(n.d.). Retrieved from WebMD: https://www.webmd.com/a-to-z-guides/questions-about-generic-drugs-
answered#1

(2012, March 25). Retrieved from My Philippine Life: http://myphilippinelife.com/philippine-generic-

drugs/

(2017, November 28). Retrieved from U.S. Food and Drug Administration:
https://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm

Stoppler, M. (n.d.). Retrieved from Medicine.Net: https://www.medicinenet.com/script/main/art.asp?

articlekey=46204

Villafuerte, F. (2016, June). Retrieved from https://fitzvillafuerte.com/generic-medicines-a-comparative-

price-study-on-generic-cholesterol-and-other-maintenance-medicines.html