Client Challenge

A European based company engaged in biosimilar drug development requested RCA to develop a regulatory strategy for seeking approval for their drug in the US and EU. The challenge was that the client wanted to utilize the data from a recently completed Phase III clinical trial conducted entirely outside the US and not under an IND. RCAs regulatory affairs team confirmed that CDERs Office of Biotechnology would have jurisdiction and proposed that the client request an initial advisory meeting as their first contact with FDA.

RCA Approach

Originally, the client did not intend to seek FDA approval making the first step verification that the clients clinical data met cGCP and cGMP, as well as the regulations and guidance documents for the Use of Foreign Clinical Data. RCA supported the client as they retrieved the proper records and documents which were sorted to conform to EMAs similar but different requirements. When reconstructed, this documentation essentially met FDAs requirements for cGCP.

Step two was to document a briefing package on behalf of the client to support an Initial Advisory Meeting request with the FDA. As the client was in the process of preparing a Biological License Application in Europe at the time, substantial Safety, Efficacy, Pharmacology and Bioanalytical data was available. The client had substantial bioanalytical data comparing their biosimilar to the European marketed reference listed drug “RLD”. Generation of comparative bioanalytical data that could be used to build a bridge, to the US RLD drug, was still on-going.

RCA submitted the briefing package to the FDA on behalf of the client and the FDA rejected the meeting request based on insufficient bioanalytical comparison data between the clients biosimilar and the US RLD. Over a four- month time period the client was able to generate additional bioanalytical comparison data to the US RLD.

RCA updated the original briefing package to include the additional data and resubmitted another meeting request. This time the meeting request was granted. However, due to the extensiveness of the supporting data presented in the briefing package, FDA offered the option to the client to convert the advisory meeting into a BPD type II meeting request. As a result, the client saved a significant amount of time towards their goal of filing a BLA in the US.

Results

The outcome of the meeting request with FDA is being withheld at this time to maintain confidentiality for our client.