Dr. Peter Kalinka is a pioneer in the field of Biosimilars and biopharmaceuticals. He has over 20 years of experience in leading the development of biosimilars, biobetters and biologics that have received regulatory approval in highly-regulated markets around the world. He was responsible for setting up the pioneering Biopharmaceuticals Division at Sandoz and the development of Omnitrope, the very first biosimilar to be approved in the EU, Australia and the US. He also spearheaded the development of Valtropin while at BioPartners in Switzerland, which was the second biosimilar to be approved in the EU. Dr Kalinka also established the Biopharmaceuticals Division at Apotex Inc., the largest generics company in Canada, where he developed a G-CSF biosimilar that was the first Indian manufactured biosimilar to be approved by EMA. Finally, he has been involved in the planning and construction of bioharmacetical manufacturing facilities. Dr. Kalinka’s expertise encompasses virtually all aspects of biosimilar development, including cloning, process development, scale up, analytical development, bioassays, pre-clinical, clinical Phases I - IV, manufacturing and regulatory affairs. Dr. Kalinka has also regularly appeared before FDA, EMA, Health Canada regulators during the scientific advice, pre-submission and submission phases of BLAs and aBLAs.
