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 Cell therapy Gene Biological products therapeutic therapy Blood/Plasma Vaccines proteins derivatives Active Peptides or Living cells Genetic Blood Proteins or ingredient proteins cultured, material components microorganisms produced by proliferated, and plasma used for genetic selected, and derivatives disease recombination manipulated prevention technology in vitro Korean 551.6 billion 10.7 billion - 457.6 billion 711 billion Won market Won (30.1%) Won(0.1%) Won (25.7%) (39.9%) (Percentage) Examples Growth Somatic cell DNA Red blood Influenza hormone, therapeutics, vaccines cells, platelets, vaccines, insulin, stem cell plasma pneumococcal anticancer therapeutics albumin, etc vaccines, etc drugs, autoimmune therapeutics 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
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
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