Everything we need to know about generic drugs

Generic drugs – modern, reliable, affordable therapy

The use of generic drugs is on the rise worldwide. In Serbia, a regular supply of the market with quality generics is ensured, the same ones that are used to treat patients in the most developed European countries.

General public often doesn’t understand the connection between a generic and an innovative (originator) drug, so patients often wonder what a generic drug is?

Generic drug is a high-quality pharmaceutical product, developed on the model of the corresponding innovative drug, and used in the same indications and equal doses as the originator drug. According to its composition, efficacy, as well as possible adverse reactions, a generic drug is completely identical to the corresponding innovative drug. As a local industry leader, Hemofarm meets the highest global production quality standards in its manufacturing plants.

Milestone in the Treatment of Chronic Diseases

According to the report of the French National Agency for the Safety of Medicines - l’Agence nationale de sécurité du médicament - As the population ages, expenditures in the treatment of chronic diseases are growing rapidly, so generic drugs as quality but cheaper therapeutic alternatives are crucial for the future sustainability of healthcare systems. With the price in France that is lower by up to 60% than the originator drugs, generic drugs are becoming the milestone in the treatment of chronic diseases, according to this report.

Is a generic drug equally effective? Why is the price of a generic drug lower?

The launch of a generic drug is preceded by the development of an innovative drug. The main characteristic of an innovative drug is that it contains an active substance that was not used for treating people previously, or else the drug contains a new combination of previously used active substances. Some innovative drugs make some serious breakthroughs and open up completely new possibilities in the treatment of a certain disease.

When an innovative drug is developed, since it is a completely new drug, its efficacy and safety must be proven, and therefore preclinical and clinical trials are conducted on animals and humans, which are very expensive and sometimes impose costs of as many as several billion dollars per drug on an innovative pharmaceutical company.

When the medicine appears on the market, the innovative company that has produced it is granted a patent protection for 15 or 20 years, meaning that no other company has the right to produce that drug in the indicated period. In this period, the drug is expensive and particularly in poor countries, it is less available to patients who need it.

What happens when patent protection expires?

Upon expiration of the patent protection, pharmaceutical companies that are capable of producing the relevant drug, are entitled to produce it. The drug is now called a generic drug and is completely equal in terms of composition, quality, and efficacy to the previously innovative medicine. Equal in terms of efficacy means that it renders equally good result in the treatment as the innovative drug and is used in the same indications and equal doses. The only difference is a more affordable price.

A Pillar of Global Health

The US magazine Wall Street Journal assesses generic drugs as a ‘pillar of global health’, because they are available to a much larger number of patients and thus directly contribute to raising the quality of treatment in the countries around the world. Patients receive a modern therapy, but now at a more affordable price. At the same time, due to the more affordable price, generic drugs also support the sustainability of healthcare systems. In the United States, 80% of prescription medicines are generic drugs.

Why is the price of a generic drug lower?

The price of a generic drug is more affordable because the drug manufacturing process does not require expensive preclinical and clinical trials that were already conducted when the drug was in an innovative phase of development. Due to the more favourable price, the availability of the drug significantly increases, and the greater availability of the most effective therapies enables quality treatment for all patients who need a particular drug. Patients therefore receive modern therapy, but now at a more affordable price.

Why does the name of a generic drug differ from the name of an innovative (originator) drug on the model of which it has been developed?

The name of the originator drug is a commercial brand name given by the laboratory in which it was developed.

Generic drug receives the name according to the used drug substance (international non-proprietary name: INN). There is a predominant practice in Europe that a generic drug has only INN, while in Serbia, a generic drug can either have INN only, or it can also have a brand name (which is the case with the majority of Hemofarm’s drugs).

Thus, regardless of the difference in name, the drug in question is equally effective in therapy, which is most important thing for patients.

‘Generic drugs, which are safe and affordable at lower prices than their alternatives, are an integral part of a cost-effective healthcare system, as they free up otherwise limited resources for new, innovative therapies, and can enable the treatment of all patients who need the therapy’, Thomas Altmann, Senior Consultant at IMS Health.