Polish biotechnology is conquering the USA. The FDA issued a landmark decision

The Rezon Bio development and production center in Warsaw-Duchnice received permission to develop and produce biological drugs from the US Food and Drug Administration (FDA). This is the third such approval from the FDA for this company and the highest number of approvals in Central and Eastern Europe.

FDA approval includes the process of developing and manufacturing the world's first biosimilar natalizumab for the treatment of multiple sclerosis.

“For the biotechnology market, the FDA's decision is another confirmation that competences are available in Poland that enable advanced, safe and repeatable production of biological drugs in accordance with American regulatory standards,” the manufacturer notes in the information provided to PAP.

President of Rezon Bio, Ph.D. Eng. Adriana Kiędzierska-Mencfeld points out that for the company's clients – from startups to the largest companies – this is another proof that it is a partner with whom it is possible to develop and scale medicinal substances under the rigor of the FDA. – This fact moves Polish biotechnology from the role of a participant to the role of co-creator of the global market of biological drugs – he claims.

The first two FDA approvals were granted to the research and development center in Gdańsk. It was there that in 2022, the process of producing biosimilar ranibizumab, an active substance used in the treatment of wet macular degeneration, was approved. A year later, approval was granted for the production of biosimilar natalizumab. The latest FDA decision allows this process to also be carried out at the center in Duchnice near Warsaw.

– Rezon Bio is the only Polish company with FDA approval for the production of biological drugs. This shows that it is possible to consistently build world-class biotechnology in Poland, says Jerzy Starak, founder of Rezon Bio.

– The foundations of these competences, as well as the Rezon Bio brand, were created within Polpharma SA, which decided to enter biotechnology in 2010. The third FDA approval that has just been obtained is proof of the maturity of this investment and the work of the teams that developed it – he emphasizes.

The company's representatives believe that long-term investments in biotechnology competences, supported by a stable regulatory environment and public instruments, can lead to the construction of lasting technological capabilities of international importance. The development of biological projects was supported from public funds, including: National Center for Research and Development, Medical Research Agency.

Rezon Bio is a European CDMO (contract development and manufacturing organization) specializing in the production of biological substances in mammalian cell systems. The company operates from two modern centers in Poland: in Gdańsk and Warsaw-Duchnice. Rezon Bio is the only Polish company with FDA approval for biological drugs. The company grew out of the achievements of Polpharma Biologics, whose biological drugs were introduced to global markets. (PAP)

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