Biosimilars are follow-on biologics of originator biologics. They have very similar physicochemical characteristics, clinical efficacy and safety profile to the reference product. These characteristics are proven in comprehensive comparability studies.
Since 2013, we have launched four biosimilar products for the therapy of autoimmune, oncology and oncohematology illnesses. From 2010 onwards, we have carried out infrastructure developments at our site in Budapest for this entirely new pharmaceutical area—and have acquired new expertise regarding the analysis, packaging, storage, logistics, marketing and distribution of biosimilar products.
In our biological quality control laboratory we perform analytical testing for the final pre-marketing quality assessment of biosimilar products.
Reference to the innovator product is an integral component of the approval.