na vrh

Medical conference - Generic and biosimilar drugs

The definition of a generic drug states that: "a generic drug, a drug that has the same qualitative and quantitative composition of active substances and the same pharmaceutical form as the reference drug and whose bioequivalence with the reference drug has been proven by appropriate bioavailability tests." Different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of the active substance are considered the same active substance, unless there are significant differences in their properties in terms of therapeutic safety and/or effectiveness. Different oral forms with immediate release are considered the same pharmaceutical form" (Law on Medicines).

The role of generic drugs:

The role of generic drugs is very important both for the state and for society. Generic and biosimilar medicines increase the availability of essential, safe and effective medicines to patients while ensuring the sustainability of the health care system.


Generic medicines are already a cornerstone of health care sustainability:

Generic drug manufacturers are the main suppliers of drugs in the EU, accounting for 56% of distributed drugs with only 22% of pharmaceutical expenditure . By 2020, it is expected that generic drugs will make up as much as 70-80% of drugs used in Europe. Generic medicines have enabled all European countries to achieve productivity profits that can be invested in other components of the healthcare system.

Statistical data from 2014 show that, if there was no competition from generic drugs, patients would have to pay as much as €100 billion more for drugs. At the same time, generic drugs significantly increase the availability of essential drugs to patients. Between 2005 and 2014, generic drugs enabled the treatment of twice as many patients in seven key therapeutic areas without affecting the total cost of treatment.

Also, generic drugs have a positive impact on adherence to therapy, which improves the availability of therapy and the health of patients, and reduces unnecessary costs in the health care system . It is well known that adherence to therapy is inversely related to participation (participation in payment) of patients. As generic medicines are associated with lower co-payments in many countries across Europe, the impact on patient adherence to therapy is also positive.  

In addition, the increased availability of generic drugs can also improve health outcomes: between 1998 and 2010, the mortality rate in Germany for patients with hypertension decreased by 50%. Also, it has been shown that greater accessibility to (ACE) inhibitors, in addition to increased cost-effectiveness, also has a key contribution in decreasing mortality.

According to the OECD (Organization for Economic Co-operation and Development), generic medicines are important in promoting increased cost sustainability of healthcare systems, without compromising the availability and quality of medicines. They state: "All EU countries consider the development of the generic market as a good opportunity to increase the efficiency of health care funds, however, many of the countries do not actually use the full potential of generic drugs."

This is precisely reflected in the example given in the table, which shows a large number of European countries through significant opportunities for the use of generic drugs, in order to achieve the most effective results:

According to the table, we can conclude that Austria, Belgium, Greece, Norway, Switzerland have an unused potential in savings, in contrast to Great Britain, the Netherlands, Sweden, Germany, and to some extent France and Spain, which enabled greater access to generic drugs.


The definition from the law on medicinal products of CALIMS states that: "a biologically similar drug is a drug of biological origin similar to a reference drug of biological origin that does not meet the requirements for a generic drug in relation to differences in raw materials and differences in the manufacturing processes of that biologically similar drug in relation to reference biological drug".

The role of biosimilar medicines in the sustainability of the health care system is very significant.

Pharmaceutical science, legislation and health policy are rapidly changing areas, especially in the area of ​​biotechnology, perhaps most in the area of ​​biological medicine, part of which is biosimilar drugs.

Biologically similar drugs currently account for about 30% of the turnover of all pharmaceutical products in Europe, with a tendency for significant growth . Over the past ten years, the growth rate of the biological market has been continuous and exceeds the growth rate of the overall pharmaceutical market.

However, the high cost of biological drugs, together with limited resources, makes them inaccessible to all patients, creating financial problems for health care systems. Biologically similar drugs provide an opportunity for state authorities to deal with this problem and enable the treatment of a greater number of patients at the expense of the state.  

A biologically similar drug is a medicinal product that has the same specification as an already approved original biological medicinal product (reference medicinal product) in the EEA. Similarity to the reference medicinal product in terms of qualitative characteristics, biological activity, safety and efficacy based on a comprehensive comparability test is determined. Clinical data clearly show that reference products and biologically similar drugs do not have clinically significant differences, so biologically similar drugs are interchangeable with reference products under the supervision of a doctor.

Since the introduction of the first biosimilar medicines in the EU in 2006, biosimilar medicines have already led to 400 million days of hospitalization  and created savings of around €1.5 billion in the EU-5 alone.

However, future opportunities are even greater with an expected cumulative spending of €47 billion (2016-2020) from 8 biologics, for which patent protection is expected to expire in the EU-5. The potential is clear from this: a 30% reduction in the price per day of treatment compared to the analyzed 8 originator biological drugs, through the introduction of competitive biosimilar drugs on the market, can produce cumulative savings in the health care systems of Europe of around €15 billion over the next five year.   

At the same time, biosimilar drugs increase the accessibility of modern treatment of patients: the availability of a biological drug similar to filgrastim ensured an increase in the number of treated patients in the EU-5 by 44% in the period between 2006-2014. The EU is an example of a leading industrial base for research and development of biologicals, including biosimilars, despite a demanding regulatory framework. The EU has a leading and key role in this area because, within 16 countries, it has its own production sites for biosimilar medicines approved in the EU or products in the development or evaluation phase.  

Biosimilar drugs stimulate competition in the market and provide better access to treatment.

It is clear that European governments must increase their efforts to support the medical justification for the use of biosimilar medicines, as their application is accepted differently in EU countries, in order to ensure their continued use. Due to the clinically proven interchangeability, the profit from the use of biologically similar drugs is multiple and shared between different stakeholders, and the most important for patients and health authorities.

Figure 7: Penetration of biosimilar drugs on the available market (December, 2015)

Source IMSQuintiles Health 2016.

Clear incentives to stimulate the use of generic and biosimilar medicines

Although European governments have already made efforts to encourage the use of generic and biosimilar medicines, it is clear that there are still opportunities to do more. Increasing the use of generic and biosimilar drugs will not only bring additional savings, but it is the only way to ensure the long-term sustainable production of generic and biosimilar drugs, which is also necessary due to market competition.

Below are some examples of European countries' governments encouraging the use of generic and biosimilar medicines:

· Education and information of healthcare professionals and patients about the quality, safety and effectiveness of generic drugs and biologically similar drugs

· Supporting the prescribing of generic and biosimilar drugs by introducing clinical guidelines and/or an electronic drug prescribing system

· Speeding up the pricing and reimbursement process for generic and biosimilar drugs


Below are several examples from the EU (France, Netherlands, Bulgaria, Spain, Ireland) which are

increase the profitability of the health care sector by promoting the use of generic drugs:

– By treating all new patients with generic drugs

- By implementing a national information and educational campaign, and prescribing guidelines on generic drugs

- By removing barriers to approval for price formation and cost reimbursement in order to improve the faster availability of generic drugs to patients

- By simplifying tender procedures with an intensive digitization process.

Generic and biosimilar drugs have proven to be a basic and integral part of health care across Europe. Without the savings from generic and biosimilar drugs, governments and payers likely would not have been able to meet the enormous demand for drugs over the past decade. For this reason, the European Association of Generic Medicines proposes and strongly encourages the governments of European countries to enable this industry to operate in a sustainable environment, which will inevitably bring positive results through healthy competition in the market of medicines whose patent has expired.