16^th European Biosimilars Congress

Biography

Biography: Adriana Kiedzierska-Mencfeld

Abstract

Approval of FYB201- ranibizumab product (Lucentis biosimilar) is key milestone for Polpharma Biologics, which is an international biotechnology company with integrated operations in the European Union (EU), developing and manufacturing biosimilar medicines. Using state-of-the-art platform technologies, Polpharma Biologics develops biosimilar products to treat a range of conditions in major therapeutic areas. Programs at Polpharma Biologics start in cell line development and transition through technical and clinical development to commercial-scale production, preparing drugs for future commercial partnerships with global pharmaceutical organizations. The company pipeline contains more than six biosimilars in different stages. FYB201 was developed by Bioeq, a Joint Venture between Polpharma Biologics and Formycon. The production of biosimilars is a process with high levels of scientific rigor and the approval of FYB201 (Ranivisio®, CIMERLI™ (ranibizumab-eqrn), is the culmination of years of dedication by Polpharma Biologics. Starting from technology transfer and process optimization, method transfer and then process validation, Polpharma Biologics actively participated in development of ranibizumab biosimilar. Currently being commercial manufacturer of drug substance ranibizumab, experienced transformation from development to commercial organization. FYB201 is highly similar to the reference product Lucentis® in terms of comparable efficacy, safety, pharmacokinetics and immunogenicity in patients with age-related neovascular (wet) macular degeneration. FDA-approval and interchangeability designation are based on a totality of evidence including analytical, nonclinical, clinical and manufacturing data. Manufacturing of product for various markets (e.g. UK, US, Europe) requires expertise in many areas, high level of GMP awareness and quality culture.