Really looking forward to meeting you at the IP Forum for Life Sciences in April. I will be hosting a discussion with tregard to naming of biosimilars, touching inter alia the following points:
- How do the European Medicines Agency and the Food and Drug Administration differ in their approach to the naming of biosimilars;
- What relevance does the EMA’s new guidance on defining medicine names offer in the context of biosimilars?
- How did the FDA alter its naming criteria in 2017?
- What are the critical considerations for any new naming effort?
This is an area of crucial importance for pharmaceutical companies, and a tremendous opportunity for IP lawyers with an interest in life sciences.