Since 2001, the patents of innovative biological medicines which have revolutionised the treatment of diabetes, tumours, and other diseases, have increasingly expired. At the same time, the so-called biosimilar medicines are appearing, their prices being nearly 25 percent lower.
Biosimilar medicines are substitutes of innovative biological medicines such as human insulin, heparin growth hormones, interferons, erythropoietin, monoclonal antibodies and recombinant vaccines. They are used in the treatment of numerous diseases, including diabetes, tumours, haemophilia, viral hepatitis, multiple sclerosis, rheumatoid arthritis and inflammatory bowel disease.
More medicines
The expiration of the patents for some of these medicines frees the path to the market for biological products with similar effect, that is biosimilar medicines.
The first of these was the human growth hormone, which contains a recombinant product. It was registered in the European Union in 2006. Today, other than Europe and Poland, it is used by physicians in the USA, Japan and Australia. It is similar to a biological medicine containing the same active substance. Although it is produced in a different way, its properties are similar.
In September 2013 the European Commission registered the first biosimilar medicine containing a monoclonal antibody. It contains infliximab, an active substance for 15 years used to treat rheumatoid arthritis, ulcerative spine rheumatoid arthritis, ankylosing spondylitis and psoriasis. This medicine has revolutionised the treatment of these diseases.
Lower costs
Prof. Piotr Wiland, President of the Polish Rheumatologic Association, believes that the introduction of biosimilar medicines to the market affords a great opportunity for the patients, particularly in Poland, where the high prices of innovative medicines limit the access to biological treatment.
The state budget also profits from this, as do the budgets of insurance companies and hospitals. Professor Paweł Grieb of the Medical Research Centre of the Polish Academy of Sciences in Warsaw estimates that reducing the prices of several leading biological medicines by just 20 percent would bring to the European Union annual savings of over EUR 1.6 billion.
An example is the longest-used biosimilar growth hormone. According to Professor Jacek Spławiński of the National Medicines Institute, it allows the National Health Fund to save 15 million PLN every year.
Citing the growth hormone as an example, Prof. Tomasz Romer, an endocrinologist, argues that patients can switch from a biological innovative medicine to its biosimilar counterpart even after many years of treatment.
Patient safety
Other experts assure that patients should not be concerned about the quality of biosimilar medicines, as compared to innovative medicines, because they are “nothing more than" their substitutes. Professor Grieb assures that all medicines must satisfy specific requirements which are more strict than those for the long-used substitute chemical medicines referred to as generics.
The producers must conduct preclinical and clinical studies, although they are abbreviated to cut the costs. However, they must prove that the medicine is safe and effective. Biosimilar medicines also require establishment of similarity (biobalance) at the chemical, biological and clinical levels.
Since 2005, all these requirements have been governed by the European Medicines Agency (EMA), which also controls the registration and permission for use of biosimilar medicines.
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