As part of the consideration of the procedure for registration of medicines it is worth paying attention to such groups of drugs as reference (= Brand name), generic and biosimilar drugs. According to statistics, more than 60% of drugs on the Russian market are generics, or reproduced drugs.

1. Definitions

According to the Federal Law 61 reference drug is called a pharmaceutical for medical use which is first registered in the Russian Federation, the quality, efficiency and safety of which is proved on the basis of the results of preclinical drug research and clinical trials of medicinal products, […] and which is used to assess bioequivalence or therapeutic equivalence, quality, efficacy  and safety of reproduced or biosimilar drug;

Reproduced drug (=generic) is a drug, which has the same qualitative composition and quantitative composition of active pharmaceutical ingredients (API) in the same dosage form (DF) as the reference drug and the bioequivalence or therapeutic equivalence to reference drug of which has been confirmed by relevant studies;

Biosimilar drug is a biological preparation similar in terms of quality, efficiency and safety with a reference biological drug in the same DF and having an identical way of introduction.

For example, the original non-steroidal anti-inflammatory drug (NSAID) “Voltaren”, used mainly for pain relief in muscles and joints, has more than 100 generics.

The first developed drug is called reference drug (or original, or Brand name). Usually pharmaceutical companies receive a patent for the invention of such a drug, which gives creators the right to produce and sell it for 20 years. In addition, there is a procedure for extending the validity of the patent for 5 years. Interestingly, the development of a new drug on average takes 8-12 years, respectively, there is not so much time for sales. Upon expiry of the patent protection period, other companies may also proceed with the production, registration and sale of generic drugs.

2.How to determine that a generic is equivalent to a reference drug?

There are several types of research aimed at confirming the quality of generics:

• Study of bioequivalence (identity of pharmacokinetic parameters (absorption, bioavailability, distribution, metabolism and excretion of drugs)
• Study of pharmaceutical equivalence (identity of composition and dosage form)
• Study of therapeutic equivalence (identity of efficacy and safety of compared drugs).

Generics are much easier to enter the market just by carrying out equivalence studies. Thanks to these studies, in most cases, generics do not have the three stages of clinical trials required in the course of the registration of drugs, which makes the process much less difficult and financially costly.

3. Are generics really equivalent to a reference drug?

As a rule, generics are much cheaper than original drugs. In this regard, it is believed that they are less effective and safe. Cheaper generics can be achieved in several ways: the use of obsolete technologies, pharmaceutical substances of low quality, etc.

A number of authors believe that generics may not only be ineffective but also unsafe. According to the literature, about 20 thousand hospitalizations in the United States and Canada are a consequence of replacing amiodarone (antiarrhythmic agent) with its “copy”.

Comparison of the clinical efficacy of the original drug bisoprolol and its generics in patients with stable angina pectoris combined with chronic obstructive pulmonary disease (Grigoryeva N.Yu.) showed significantly lower efficiency of generics compared to the reference drug Conсor®.

It is worth noting that there are quite a lot of such studies, and in rare cases you can find positive results of comparison of generics with reference drug, which creates a very unpleasant impression of their application.

References:

1. https://gmpnews.ru/2017/12/osobennosti-patentovaniya-lekarstvennyx-preparatov-i-bad/
2. https://dsm.ru/docs/analytics/november_2018_pharmacy_analysis.pdf
3. Федеральный закон “Об обращении лекарственных средств” от 12.04.2010 N 61-ФЗ (последняя редакция)
4. Сарсенбаева С.С. Оригинальные препараты и генерики: качественный выбор. Ибуфен // Журн. Медицина. – 2015. – №3 (153). – С. 105-110
5. Максимов М.Л., Ермолаева А.С. Актуальные вопросы взаимозаменяемости лекарственных препаратов: оригинальный бисопролол или воспроизведенные лекарственные средства (дженерики)? // РМЖ. 2018. № 6(I). С. 29–32.