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Tasks of a GMP Development Manager for Biosimilars
Copy of Biological Drugs
Biosimilars - Copying biopharmaceutical drugs
Since patent protections of biopharmaceutical drugs are running out several biotech companies started to copy these drugs. In contrast to generics (copy of low molecular drugs, e.g. Aspirin) these copies may possess microheterogeneities due to different expression systems, thus the name biosimilars was chosen. To copy biopharmaceuticals next to agent, effiency and application also production process of original manufacturer must be adapted which represents major challenge in this business.
Prospective project managers dealing with biosimilar development and production have to face new international guidelines expecting bioequivalence of follow-on drug which drastically depends on imitation of original manufacturing.
This seminar illustrates biosimilar production and its hazards. Examples from industry and necessities of compliance in biosimilar production are demonstrated.