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Cortex - Life Sciences Insights

| less than a minute read

What’s in a name? The Latest Considerations in Naming Biosimilars

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:

  1. How do the European Medicines Agency and the Food and Drug Administration differ in their approach to the naming of biosimilars;
  2. What relevance does the EMA’s new guidance on defining medicine names offer in the context of biosimilars?
  3. How did the FDA alter its naming criteria in 2017?
  4. 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.   


life science, ipt, italy, biosimilars