BSoD-09_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.