Most drugs are high-priced, and certain segments of people simply cannot afford to buy what they need. Lots of medications that are currently present on the market are known as “generics“.
Those normally come as cheaper versions of branded drugs and are often offered at various pharmacies on the web. As of today, many users feel uncertain whether or not they should try the less pricey versions of their meds, fearing that this somehow may be connected with drug potency and efficiency.
However, those fears are totally ungrounded – to understand this we are going to look on the nature of generics from a closer perspective.
What are generics and how come they cost less
When it comes to the heavy price of a branded drug, the entire scheme of drug development and licensing is the culprit.
Before the drug can be released on the market it needs to undergo several years (sometimes, a decade) of development, and this business can cost to company more than $2 billion. There are three phases of clinical trials and they consume most of the money and time because it is the only way the company can get its medication licensed and sold for a specific condition.
As soon as the company is through with licensing it is granted patent protection, which ensures that it can sell the drug exclusively for a period of 20 years and compensate for its expenses.
Generic drugs allow their manufacturers to cut down on expenses greatly because their release does not involve research; on average, this makes for an 80% to 85% difference in the final price.
Does this still mean generic drugs are safe?
Even though free from the necessity to pass clinical trials, generics are required to meet a lot of other strict requirements.
As dictated by the FDA, a generic drug can only end up on a pharmacy’s shelf if it complies with the following six conditions:
- is used for the same indications;
- during its manufacture process, meets the regulations of FDA’s good manufacturing;
- is produced in accordance with the same batch requirements for quality, identity, purity, and strength;
- has the same composition as the innovator drug (chemically identical active ingredients);
- is bioequivalent;
- is identical in dosage forms (capsules, tablets), strength, and drug administration way.