List of Biosimilars Companies in Poland - 2

Bioton S.A. - European Biotech Company producing human insulin: API and finished forms in cartridges and vials. For more than 20 years, we have been providing people with diabetes with efficacious and safe medicines. Bioton S.A. is an unquestionable leader on the Polish market, and in the world’s top eight commercial manufacturers of recombinant human insulin. Bioton S.A. continuously invests in the development of Polish biotechnology. We were the first company in Poland which, in cooperation with one of Polish scientific institutes, managed to commercialize the results of the Biotech Transfer. We apply the most current therapeutic and technological solutions to alleviate diabetes treatment for patients. We strive to build comprehensive solutions for the prevention and treatment of diabetes. Bioton S.A. offers CMO/CDMO and QC services. Our activities are based on QbD in line with cGMP standards. Bioton S.A. supplies also a range of innovative gastroenterological FSMP (Foods for Special Medical Purposes).

Mabion S.A. is a Polish biopharmaceutical CDMO providing extensive drug development and biomanufacturing services to pharmaceutical and Biotech companies globally. We offer services for clinical and commercial manufacture of recombinant protein therapeutics, including process and analytical development services, GMP manufacture of Drug Substance (from small scale up to 4 x 2.000 liter single-use bioreactor sizes), GMP manufacture of Drug Product in our state-of-the-art filling line and an extensive set of analytics and QC tests. This is supported by a robust quality assurance and regulatory affairs department. In addition to our regular CDMO offering, Mabion also took part in the global fight against the coronavirus pandemic by signing a record contract with Novavax Inc. in October 2021 for the commercial production of the antigen for their COVID-19 vaccine. This partnership has proven to be very successful, leading to several subsequent additional services offered by Mabion, augmenting the main commercial-scale manufacturing contract. We aim to establish ourselves as a key global player in the global contract manufacturing and contract drug development market offering a broad range of high-quality integrated services to the Biotech and pharmaceutical market. Mabion is a public Company, listed on the Warsaw Stock Exchange (WSE: MAB). For more information about the Company, please visit www.mabion.eu