Teva CFS Book English

36 What are biological drugs? The biological original drugs that became available in the mid 80s are completely different to the drugs that we were familiar with until then. The active ingredient in biological drugs is a protein built from a very large number of molecules and that is manufactured by a living organism (plant cells, bacterial or mammal cells) in controlled and complex conditions and environment. The cost of treatment with biological drugs is significantly higher than the cost of treatment with any other drug, and therefore the availability of these treatments is limited. The biological drugs have been proven as effective and life saving in a variety of therapeutic contexts and for fatal diseases. Stimulating the imagination and creating revolutionary value When Teva entered the world of biological products, there was a need for a vision, creativity, and reading the strategic map. It was also clear that it was the largest challenge that required special evaluation and the development of new capabilities. The biological products are extremely complex products. They are composed of large molecules whose active raw material is a protein, sensitive to environmental conditions like temperature and vacillation. Therefore, the investment in materials and processes is immense and the actual products are much more expensive compared to non- biological products. The company started developing a portfolio of “biosimilar” products, meaning generic versions of original biological drugs. Since the protein is actually a huge molecule, it can’t be exactly identical to the original molecule. Therefore, in the context of biological products, it is not biogenerics but biosimilar and we don’t commit to complete identicalness between these products, but the similarity is strong. 2020 is already here Anat Cohen, Section Head at the T&SA Department, explains: “With generics, comparisons are made and the similarity between your preparation and the innovator's preparation is shown. If a work process of 3-4 years suffices with regular generics, with biological preparations, it is more like 7-8 years. This is because you need to characterize the substance, synthesize it, produce it, and conduct clinical trials that take several years and then submit for approval. In 2011 we started with projects whose launches were planned for 2018-2019 and we are currently dealing with products whose launches are planned for 2020 and on. Since the site in Kfar Saba entered the picture at an advanced stage and not right away, it’s possible to say that the overall work on a biological product can last even a decade”. The news came out of Kfar Saba Teva’s goal was to continue establishing Kfar Saba as the flagship plant of manufacturing the biological products in addition to Copaxone. Entering the domain was a huge challenge and the pride for choosing the plant as a global leader in biological products production was great. The employees were very committed, the learning process was serious, and the excitement for the new domain was high. According to Anat Cohen: “If Kfar Saba didn’t have proven results, leadership, and excellence, there is no doubt that we would not have been allocated the The next leap - biological products Teva’s entrance to the world of biological products in 2012 and the choice of Kfar Saba as a global leader in their production, was a source of immense pride and the preparation required a great deal of creativity. Filgrastim - The first biological product that was launched, is manufactured and marketed from Kfar Saba to the entire world and additional products are already following its footsteps. Meet the contemporary generation of drugs, that make it possible for the body to heal itself.