This article is a part of Poland Unpacked. Weekly intelligence for decision-makers
Rezon Bio, part of the Polpharma Biologics group controlled by Jerzy Starak, is gearing up to produce biologic drugs for the U.S. market. The company plans to capture orders from Western pharmaceutical giants that have so far been sent to factories in China. It has secured nearly PLN 17 million (EUR 3.6 million) in grants to expand its drug substance manufacturing center.
Jerzy Starak, one of Poland’s wealthiest individuals, is betting this year on a new line of business. His Polpharma Biologics, operating under the Rezon Bio brand for the past few months, will focus on producing biologic medicines on behalf of foreign pharmaceutical companies.
The biotechnology company intends to compete for some of the contracts that currently go to Chinese factories. Rezon Bio is negotiating with potential international partners to relocate production to its facilities in Poland. Drugs manufactured in Poland are expected not only to supply European markets but also to reach the United States.
Preparations for U.S. sales have been underway for several years.
Through the FDA to the U.S. market
The path to U.S. sales for Rezon Bio is paved by accreditation from the U.S. Food and Drug Administration (FDA). The company is the only Polish firm authorized by the FDA to manufacture biologic drugs for the U.S. market. At the end of February, Rezon Bio secured its third FDA approval – this time for its production facility in Warsaw-Duchnice, covering the development and manufacture of the world’s first biosimilar natalizumab for the treatment of multiple sclerosis. The first two approvals had been granted for production lines in Gdańsk in 2022 and 2023.
“FDA verification covers not only production lines but also the management of the manufacturing process for each batch and the entire quality system,” explains Dr. Adriana Kiędzierska-Mencfeld, CEO of Rezon Bio.
She adds that this is an ideal moment to change the company’s operating model.
“We have both the infrastructure and FDA certification, which allows us to grow and supply products to global markets. We have experience with both clinical trial products and commercial products. We also have projects delivered for major partners such as Sandoz and Teva,” emphasizes Dr. Kiędzierska-Mencfeld.
Currently, Rezon Bio operates as a CDMO (Contract Development and Manufacturing Organization), producing drugs on behalf of two companies.
“We are in discussions with additional potential clients about new projects,” says Dr. Kiędzierska-Mencfeld.
A young, yet established company
The Rezon Bio brand is very new – on the market for only five months. It was spun off from Polpharma Biologics following the decision to pivot the company toward contract manufacturing of biologic drugs as a CDMO.
Why now?
“Starting out immediately as a CDMO is extremely risky. No pharmaceutical company will entrust a project to an organization that lacks experience and cannot demonstrate, through its own products, the ability to successfully develop and manufacture medicines,” says the CEO of Rezon Bio.
A rare case where geopolitics works in their favor
The company benefits from the current geopolitical climate. Europe, seeking since the pandemic to reduce dependence on China, is promoting the reshoring of pharmaceutical production within the EU. Regulations being developed in Brussels are expected to include financial support for local manufacturing. Rezon Bio hopes to capitalize on this new policy and aims to reclaim some of the production currently sent to Chinese factories.
“We are not as low-cost as Chinese suppliers, but we are cost-competitive. And FDA certification allows us to offer products in the United States,” says Adriana Kiędzierska-Mencfeld.
The company expects that a portion of orders currently fulfilled in China could be relocated to Poland by Western pharmaceutical companies.
“We are talking to clients who are considering splitting production across multiple locations. In such a model, production for the Chinese market would remain in China, while production for European and U.S. markets would be moved to a company based in Europe. Final decisions have not yet been made, but our advantages in this area are significant. We are seeking orders in global markets – not only in the United States and Europe, but also in other regions,” the CEO explains.
Europe seeks to regain its strength
Brussels is encouraging manufacturers, including drug producers, to bring production back to their home markets. The process has begun, but progress remains extremely slow.
“EU grants are available to support the relocation of production to Europe. We can see that companies outsourcing production are starting to take advantage of these instruments,” says the CEO of Rezon Bio.
A few months ago, the company received a grant from Poland’s National Centre for Research and Development (NCBiR) to implement artificial intelligence for streamlining manufacturing processes. In February, it secured a PLN 16.94 million (EUR 3.6 million) grant from the STEP (FENG) program for the “development of a modern drug substance production center” as part of the Strategic EU Strengthening initiative in biologic medicines.
Krzysztof Kopeć, president of the association of National Pharmaceutical Manufacturers, says that today funding for investments aimed at relocating production to Europe is very limited – if not practically unavailable.
“We are pushing for the creation of a special EU fund to support production relocation to Europe. Without incentives, it will be difficult to convince companies to make major business decisions. We are negotiating in Brussels to ensure that funding is included in the EU’s next financial perspective, starting in 2027,” says Mr. Kopeć.
Łukasz Kościjańczyk from the consulting firm Crido highlights another key condition for successfully relocating drug production to the EU.
“For factory relocation to work, price cannot be the sole criterion when setting reimbursement for a given drug. Many companies, when preparing a business plan for potential investments in Europe, ask whether the payer will consider that production costs in Europe are higher than in China. Without guarantees that European manufacturers will not lose out to those still producing more cheaply in China, it is unrealistic to expect any company to return,” the Crido expert explains.
Key Takeaways
- Geopolitics and funding support order acquisition: Europe seeks to reduce dependence on China, and the EU is promoting the relocation of production from China to the Union. Drug manufacturers are considering splitting supply chains, although relocation is constrained by high costs and a lack of systemic incentives within the EU.
- Rezon Bio, part of Jerzy Starak’s Polpharma group, is developing a contract manufacturing model for biologic drugs (CDMO). The company aims to capture a share of orders currently fulfilled in China and is in discussions with Western pharmaceutical companies to relocate production to Europe and the U.S.
- Key advantages: Rezon Bio is the only Polish firm with FDA accreditation to manufacture biologic drugs for the U.S. market (three approvals, the latest in February 2026). It has modern production facilities and extensive experience collaborating with major partners, including Sandoz and Teva. The company recently secured nearly PLN 17 million (EUR 3.6 million) in grants to expand its production center.