Natalizumab, the world’s first biosimilar drug for multiple sclerosis, produced in Poland, has been approved by the European Medicines Agency (EMA), adding to the biosimilar legacy that Warsaw seems to be building in the hope of improving the Polish economy, but also patients’ lives across Europe.
The European Commission approved natalizumab based on a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP).
This biosimilar natalizumab, a monoclonal antibody, has been completely developed and manufactured by Polish company Polpharma Biologics. It is now set to become available in the European market, with distribution rights granted to Sandoz, Polpharma Biologics’ commercial partner.
Natalizumab has received approval in Europe as a disease-modifying therapy for adults with highly active relapsing-remitting multiple sclerosis (RRMS). RRMS is a progressive, chronic, and inflammatory neurodegenerative disease affecting the central nervous system, with significant impacts on patient mobility, necessitating lifelong treatment.
What exactly is a biological and biosimilar drug?
These drugs are characterised by their active substances, which are produced by living organisms. They encompass a wide range of different substances, often complex mixtures of sugars, proteins, and nucleic acids.
What sets biological drugs apart is that they are obtained by purification from living cells, whether from humans, animals, or microorganisms. In contrast, other medications are classified as ‘small molecules’ and are usually chemically synthesised.
Biological drugs have played a transformative role in the field of medicine, proving effective in treating conditions that were previously resistant to traditional pharmaceuticals.
Biosimilar drugs, as the name suggests, are drugs that are similar to substances already on the market, known as reference drugs, whose market exclusivity has expired.
Other pharmaceutical companies can develop new methods of producing these “look-alike” substances. The term “look-alike” is used because it is practically impossible for a living cell to produce an exact copy of the original substance.
Biosimilars primarily focus on maintaining the effectiveness and safety of the drug, which is confirmed through clinical studies.
While biosimilars are sometimes likened to “biological generics,” this comparison oversimplifies the situation. Generic drugs are small molecules that can be identically replicated by different companies using various technologies.
Given that biological drugs are often expensive, their accessibility is notably insufficient, especially in Poland. These therapies are available for Polish patients only in special drug programmes, for which only patients who meet very stringent criteria are eligible.
Krzysztof Kopeć, president of National Drug Manufacturers, believes that the emergence of competitive biosimilar drugs may lead to a greater presence of these pharmaceuticals in the market, ultimately reducing therapy costs for healthcare systems and improving patient access.
“For instance, after the introduction of another biosimilar drug, infliximab, medicine prices in Poland decreased by over 60% in just a few years,” he told Euractiv.
Biosimilars: a positive impact on the economy
Kopeć noted that “Central Statistical Office data show that the domestic biotechnology industry is one of the most innovative and that the new competencies of domestic companies raise the level of innovation of the entire Polish economy”.
This innovation demands the employment of highly skilled professionals, offering them opportunities to work in advanced development and production centres throughout the entire biological drug development process.
Piotr Korycki, president of the management board of Polpharma Biologics in Poland, emphasised the competitiveness and world-class quality of Poland’s biotechnology sector, leading to the return of more than 50 Polish scientists from abroad.
“Foreign specialists also view Poland as the place to be,” he said.
“As a result, Polish biotechnological companies file more and more patents in the field of biotechnology – 37 in the past year.”
Including the biosimilar natalizumab, Polpharma Biologics has two biosimilar drugs in its portfolio, which have been approved both by the FDA and EMA.
Ranibizumab, used for treating eye diseases, is already offered to patients in Europe and the US. Five remaining projects at various stages of development will target, among other diseases, multiple sclerosis, Crohn’s disease, and psoriasis.
At least four projects are aimed to be in the commercialisation phase by the end of the decade, with more than 15 to be in development.
(Paulina Mozolewska – Edited by Vasiliki Angouridi/Zoran Radosavljevic Euractiv.com)
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