Cost for clinical trials : "Approximately $250~650 million" for biosimilars. Generally, biologics can be categorized as recombinant therapeutic proteins, cell therapeutics, gene therapeutics, or biological products. Biological products can be further divided into blood/plasma derivatives and vaccines. Biologics Category Recombinant therapeutic proteins Cell therapy Gene therapy Biological products Blood/Plasma derivatives Vaccines Active ingredient Peptides or proteins produced by genetic recombination technology Living cells cultured, proliferated, selected, and manipulated in vitro Genetic material Blood components and plasma derivatives Proteins or microorganisms used for disease prevention Korean market (Percentage) 551.6 billion Won (30.1%) 10.7 billion Won(0.1%) - 457.6 billion Won (25.7%) 711 billion Won (39.9%) Examples Growth hormone, insulin, anticancer drugs, autoimmune therapeutics Somatic cell therapeutics, stem cell therapeutics DNA vaccines Red blood cells, platelets, plasma albumin, etc Influenza vaccines, pneumococcal vaccines, etc 2) Understanding therapeutic monoclonal antibodies Antibodies are an essential component of our immune system. They recognize and bind to specific antigens, thereby neutralizing their effects. The ability to recognize specific targets have helped antibodies become a useful tool in the treatment of many diseases. The antibodies used for treatment of disease are usually monoclonal, meaning that they are made from identical immune cells and therefore recognize the same part of a certain antigen. These therapeutic monoclonal antibodies bind to specific markers on immunoregulatory proteins or cancer cells, and initiate (or alter) our body’s immune response. 3) Development, clinical trials and approval of biosimilars
The bioreactor animal cell culture process - Assay Method Development : After a cell line has been established and the resulting antibodies have been purified, the next step is to analyze the glycosylation patterns of the antibodies. Glycosylation analysis is essential in understanding the structure of the antibody that has been produced, and demonstrating its biosimilarity to the original drug in terms of safety, purity, and potency. Therefore, developing an elaborate assay for glycosylation analysis is essential in determining the overall success of the biologic. These assays must be conducted regularly, as cells are constantly undergoing change. In addition, the handling and preservation of biologics can be tricky, when compared to drugs, and there is always a risk for the drug being spoiled during distribution. Therefore, biologics need extra attention. 2) The Biosimilars and Novel Therapeutics of CELLTRION Products (Biosimilars) Product Name Target Substance Original Name Major Indication Development Status Remsima/Inflectra Infliximab Remicade (J&J) Autoimmune diseases Approved by the US FDA and MFDS. Also approved in EU, Canada and Japan Biosimilar Candidates Project Name Target Substance Original Name Major Indication Development Status CT-P06 Trastuzumab Herceptin (Roche) Breast cancer Approved by the MFDS CT-P10 Rituximab Rituxan/MabThera (Roche) Non-Hodgkin lymphoma Applied for AEMA approval CT-P05 Etanercept Enbrel (Amgen) Rheumatoid arthritis Pre-clinical study CT-P15 Cetuximab Erbitux (BMS) Colorectal cancer Pre-clinical study CT-P14 Palivizumab Synagis (Asterazeneca) Respiratory diseases Under process development