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They include proteins, monoclonal antibodies and vaccines that are considered to be “ highly similar ” to biological products that have already been approved by the FDA. Significantly, insulin was deemed to be a biologic as of March 23, 2020, making it a reference product for the development of biosimilar versions.
2) Darzalex (daratumumab) Darzalex is a targeted monoclonal antibody that slows or stops the progression of multiple myeloma (a blood cancer) by binding to the CD38 protein on multiple myeloma cells. The monoclonal antibody targets CD20, a protein found on the surface of B lymphocytes (B cells). billion in 2022, a 32.44
The rising demand for protein therapeutics, such as monoclonal antibodies and vaccines , is driving advancements in protein expression technology to ensure efficient and scalable production. Prokaryotic Expression System: This expression system is used in structural analysis, antibody generation and functional assays.
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