October 1, 2019

Impact: High

  • The CHMP adopted a positive opinion recommending a change in the MAA for Remsima to include a new route of administration, new strength, and new pharmaceutical form:
  • Remsima 120 mg solution for subQ injection using prefilled pens or syringes.
  • It is only authorized in the RA indication.

inThought Analysis

This recommendation from the CHMP sheds some light onto how regulatory agencies will consider the subQ formulation of Remsima. It appears that recommendations will be given only for the indications that were evaluated in clinical trials, which is not a surprising outcome considering the debate that occurred at EULAR 2019. While the IV form of Remsima is of course a biosimilar because of the equivalence demonstrated with originator infliximab, the subQ formulation does not have a subQ originator t o be compared with, and would not be considered a biosimilar. Celltrion will very likely contest the suggested indication and argue for extrapolation to other indications.

It is unclear how Celltrion will proceed: will the company pursue trials in each indication? And if so, will they try to obtain patent exclusivity for subQ CT-P13?

Another thing to consider is that physicians will have the option of offering subQ CT-P13 off-label for other indications, though that would likely have a minimal effect on the current market.

Sources: EMA Summary of Opinion

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