Dr. Peter Kalinka is Head of R&D, Innovation and Business Development at Bionovis S.A., Valinhos, possesses in-depth knowledge of drug development and has directed a large number of development projects which include(d) Therapeutic Proteins, Monoclonal Antibodies and Fusion Proteins. Several of these were approved by the EMA, FDA, many were managed by him from inception to submission. His knowledge in overall development spans cloning, process development, scale up, analytical development, bioassays, pre-clinical, clinical Phases, to manufacturing and regulatory affairs. Dr. Kalinka looks back on a large number of meetings with FDA, EMA, Health Canada as well as other jurisdictions and has dealt with these regulators during the scientific advice, pre-submission and submission phases. Dr. Peter Kalinka is a pioneer in the biosimilars arena, being responsible for the development of Omnitrope, the very first biosimilar to be approved in the EU, Australia and the US. He was then involved in the development of the second biosimilar to be approved, Valtropin. This was followed by many other biosimilars, bio-betters and novel biologics. From 2006 to 2013 Dr Kalinka established, de-novo, a functional Biopharmaceuticals Division within a small molecule generics company and successfully initiated the development of 3 therapeutic proteins and 3 monoclonal antibodies. He developed a biosimilar G-CSF which was approved by the European commission in May 2014. This was the first Biosimilar product to be approved in Europe, entirely developed (except for the clinical program) and manufactured in India. In December of 2014 FDA accepted the application for the first biosimilar of Amgens Neulasta, Peg G-CSF, under the 351(k) pathway which was largely developed under his direction. In early 2015 the biosimilar G-CSF mentioned above was also accepted by FDA. To date Dr Kalinka has been in charge of the development of more than 14 Biosimilars and Biobetters.