Biologicals and biosimilars

As many pharmaceutical companies seek to diversify their products to include biological drugs as well as small molecules, new regulatory and intellectual property issues are being raised. These range from the procedure of obtaining marketing approval and price reimbursement for biosimilars to difficult questions of patentability for stem cells and DNA based inventions. This toolkit contains useful information on the challenges posed in this area.

Biologicals and biosimilars
Biosimilars and the issue of duplicates
The new overarching guideline for biosimilars
Reimbursement of biosimilars
Biosimilars explained