The interview was conducted by and published in “Kierunek Farmacja” magazine.
The development of biosimilar natalizumab was not merely a project to replicate a molecule; it was a comprehensive process of building end-to-end industrial competence, from cell line development to global regulatory approval. Dr Rafał Derlacz, Innovation Director at Rezon Bio, explains why this initiative has become a milestone for Polish biotechnology know-how.
Aldona Senczkowska-Soroka: Let’s start with the basics: what exactly is natalizumab?
Rafał Derlacz: It is a monoclonal antibody – in other words, a biological drug with a highly specific mechanism of action. Its function is to inhibit the migration of hyperactive leukocytes across the blood–brain barrier, thereby reducing the inflammatory process within the central nervous system. The biosimilar natalizumab developed by our specialists has the same properties and applications as the reference product. For this reason, it is classified as a biosimilar.
Where can it be used?
Natalizumab is primarily indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS). This therapy significantly reduces the frequency of relapses and slows down the disease progression, resulting in a meaningful improvement in patients’ quality of life. From a pharmaceutical and biotechnological perspective, it is worth emphasizing that we are talking about a highly complex drug, both in terms of molecular structure and manufacturing process. It is not a conventional generic that can be quickly reproduced, but a therapy that requires very advanced quality control at every stage of production. It is also worth noting that the biosimilar natalizumab developed in Poland is currently distributed globally by Sandoz under the brand name TYRUKO® in accordance with a license agreement.
The complex work on the biosimilar natalizumab took more than 10 years. What were the key milestones along the way?
I would say it was building the full scientific competence and technological capability required to manufacture the product to a standard accepted by global regulators. So, in the case of natalizumab, it was not simply a matter of reproducing the active substance itself. It was a program aimed at building industrial-scale competence rather than a single research project. The work covered the full cycle of biological drug development – from cell line development, through process development, purification, and scale-up, to the preparation of complete quality and regulatory documentation for submission to the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA). Each of these stages required years of experience, iteration, and learning – including learning from mistakes.
You led this project. Do you recall any particularly difficult challenges?
The greatest challenge was managing the project on multiple fronts simultaneously. We were advancing the technical development of the product, engaging with regulatory authorities, and preparing clinical trials all in parallel. At the time, we did not yet have our own laboratory and manufacturing infrastructure, so we also outsourced some of the work to external partners. At the same time, we were building our own laboratories and production lines, assembling a team that had to become involved in the project immediately. Equally important was the development of know-how that had not previously existed in Poland, because no one had ever undertaken a comparable project comprehensively from start to finish.
Is that why you describe this first Polish monoclonal antibody “groundbreaking”? What does approval by the EMA and FDA mean for Polish patients and for the domestic biotechnology industry?
The groundbreaking nature of this project does not lie merely in the fact that the drug was developed. Natalizumab is an example of a therapy based on monoclonal antibody technology, a platform whose foundations were recognized with the Nobel Prize in the 1980s. The molecule itself was developed later, as part of industrial research and development programs. Natalizumab was first launched on the market in 2004 and has been available in Europe since 2006 as a treatment for patients with multiple sclerosis.
The fact that natalizumab was produced, scaled up, and globally commercialized by Polish experts demonstrates the breadth and depth of the expertise our team has built over the years. Approval by both the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) confirms that the entire process, from molecule development to manufacturing, meets the most stringent global quality and safety standards. For the Polish biotechnology sector, this sends a clear message that domestic centers are not only capable of participating in global value chains, but also of shaping and expanding them. For the system, it provides evidence that sustained investment in biotechnology can have a lasting, rather than an isolated one-off success. For patients, it means greater security of supply and potentially better access to advanced biological therapies.
How was it possible to build a team and infrastructure for such production at a time when the biological medicines sector was practically non-existent in Poland?
It was a gradual process that required a high level of consistency. When the project was initiated in Poland, there was a shortage of experienced specialists as well as infrastructure adapted to the manufacture of drugs in compliance with Good Manufacturing Practice (GMP) standards. In the case of biological drugs such as monoclonal antibodies, GMP compliance is particularly critical. These therapies are produced using living cells, and even minor variations in the manufacturing process can affect the product’s quality, structure, and clinical performance. For this reason, regulatory authorities such as EMA and FDA evaluate not only the molecule itself, but the entire manufacturing system.
The team was built in parallel with the infrastructure. We invested in people who gained experience through real projects, often without established models to follow. Equally important was adopting a long-term perspective: the development of biological drugs, including their biosimilars, does not end after a few years, but requires stability and strategic patience.
Today, it is clear that this effort has paid off: strong competencies have been established and can now be leveraged in subsequent projects, including those delivered within the CDMO model.
The Prix Galien Polska award for natalizumab highlights its innovative character. How important is this distinction for Poland’s position in the European pharmaceutical industry?
The Prix Galien is an award that carries significant weight in the pharmaceutical and biotechnology community. It is not a distinction for declarations, but for the real clinical and technological value of a project. In this case, it confirms that Poland can be seen not only as a location for contract manufacturing or a cost-efficient operations base, but as a source of advanced biological expertise. It sends an important signal to partners across Europe and beyond that it is worth locating projects requiring a high level of know-how here.
Over the long term, such awards strengthen the credibility of the entire ecosystem, from scientific research, through industry, to regulators, and support Poland’s transition from a participant in European biotechnology to a co-creator of its future direction.
Interview by Aldona Senczkowska-Soroka, editor of Kierunek Farmacja magazine
REZON BIO: A European-based CDMO (Contract Development and Manufacturing Organization) built on the scientific and manufacturing legacy of Polpharma Biologics, specializing in the development and manufacture of biological drugs. The company operates facilities in Gdańsk and Warsaw-Duchnice, offering end-to-end CDMO services to global markets.
