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Tyruko: a breakthrough biosimilar medicine

Biosimilar medicines are an innovative solution in the field of pharmacology. They are increasingly becoming a key part of healthcare, offering patients access to effective biological therapies. Based on biotechnology, these substances are designed to mimic already existing biological drugs, while lowering costs and increasing availability. What does Poland have to do with this?

Dr. Rafal Derlacz – a biotechnologist at the University of Warsaw, played a key role in the development of Tyruko, a breakthrough biosimilar drug. Tyruko was designed to replicate the effects of natalizumab, a monoclonal antibody known for its use in treating diseases such as multiple sclerosis. This remarkable achievement was made by Polpharma Biologics SA, a leading pharmaceutical company based in Poland, which recently received certification from the U.S. Food and Drug Administration (FDA). [1]

It is worth mentioning that Dr. Derlacz boasts an impressive track record, combining his knowledge of biotechnology with his proficiency in managing drug development and registration projects. His career began at the University of Warsaw, where he earned his PhD in biological sciences, focusing on the modulation of mammalian topoisomerase I relaxation activity by the protein kinase ck2. Dr. Derlacz’s contributions extend beyond academia – he held an assistant professor position in the Department of Biology while gaining invaluable experience in the pharmaceutical industry. 

Tyruko, the Polish equivalent of natalizumab, is compatible with the reference drug (Tysabri) in terms of the intravenous route of administration and dosing regimen. This innovative drug was meticulously developed through the collaboration of scientists, biotechnologists, clinicians and Polpharma Biologics experts. The company announced it is ready to produce Tyruko for the global market. It is noteworthy that Tyruko has successfully passed the FDA certification process, which is famous for its stringent criteria. The company anticipates that the European Medicines Agency will grant marketing approval for it soon

What’s next?

The FDA granted market approval for the drug Tyruko after reviewing a comprehensive dataset that included analytical, functional and clinical information. This approval comes with the requirement to label the drug with safety warnings and establish a risk evaluation and mitigation strategy (REMS), similar to the approach used for the reference drug Tysabri. Once Tyruko is on the market, the drug will be available under a REMS program overseen by Sandoz. [2]

New generation of biotechnologists in Poland

The University of Warsaw and Polpharma Biologics have strengthened their collaboration in 2020, being a significant step toward connecting academia and industry. The cooperation paves the way for biotechnology students at the Faculty of Biology to be comprehensively prepared for careers in the biopharmaceutical industry. [1]

How will this solution affect the future of the Polish market? We will find out soon.

Bibliography:

[1] University of Warsaw, Dr. Rafal Derlacz, lecturer at the Faculty of Biology of the University of Warsaw, co-developer of a Polish drug registered by the FDA, https://www.biol.uw.edu.pl/dr-rafal-derlacz-wykladowca-na-wydziale-biologii-uw-wspoltworca-polskiego-leku-zarejestrowanego-przez-fda/, (accessed on October 5, 2023).

[2] Puls Medycyny, FDA approves first biosimilar drug for MS treatment, https://pulsmedycyny.pl/fda-zatwierdzila-pierwszy-lek-biopodobny-do-leczenia-sm-1194155, (accessed on October 5, 2023).

Zuzanna Czernicka
Bio:
I am deeply immersed in the dynamic world of banking and FinTech. My focus encompasses critical areas such as foreign exchange, payments, and the cutting-edge landscape of FinTech regulation. My academic interests span a broad range of topics including electronic payments, Open Banking, blockchain impacts, the DeFi ecosystem, NFTs, ICOs, and tokenization. I am dedicated to understanding and analyzing the new regulatory frameworks shaping the FinTech world. Currently, I am writing my Bachelor\'s thesis on the robo-advisory services. This work reflects my commitment to understanding and contributing to the regulatory frameworks that are vital for the growth and governance of emerging financial technologies.
Written by:

Zuzanna Czernicka

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