Biosimilars and the issue of duplicates
Belinda Lavin and Paul England discuss the use of duplicate naming for biosimilars and its possible implications.
The new overarching guideline for biosimilars
Matthew Royle examines the EMA's three new draft guidelines applying to all biosimilars.
Reimbursement of biosimilars
With much interest focussing on biosimilars, lawyers from our European team discuss the difficult issue of how these are reimbursed.
Biosimilars explained
Biosimilars are biological medicinal products that are similar to another biological product that has already been authorised.
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.