12.17.20 -- 2020's Greatest Biosimilar Achievements

This case serves as a reminder that sometimes it is impossible to fully evaluate the likelihood of success in biosimilar litigation before the challenge begins.

In Part 2 of this two-part article, we discuss what information is critical to support the sponsor’s argument that the proposed product is biosimilar to the designated reference product, when it is appropriate to do so, and what level of detail it should have for each stage of interaction with the FDA.

As the members of the Biosimilar Development Editorial Board emphasize here, there is a lot to be thankful for in the biosimilar world. Check out the first of what will be a four-part series showcasing the editorial board’s thoughts on the past year and the year(s) ahead.