2023-06-14
Taiwan CDE Consultation Preparation and Application for Biosimilar Registration
EffPha’s team of scientific and regulatory experts have a strong understanding of the local and global regulatory pathways. We are able to provide scientific insights and regulatory strategic input relying on our extensive experience to facilitate your drug development projects.
The Challenge
A global pharmaceutical company reached out to EffPha for assistance in preparing and submitting a consultation request to the Center for Drug Evaluation (CDE) in Taiwan.
The client intended to seek approval of their biosimilar product in Taiwan, and had to determine an approved biological drug as the reference product of their biosimilar.
The client has completed a Phase 1 PK study using their biosimilar, US reference drug and EU reference drug. In addition, a Phase 3 study was conducted by the client to demonstrate similarity between the biosimilar and EU reference drug.
The primary challenge was to obtain the CDE’s agreement on the adequacy of the existing clinical data in support of biosimilar registration application in Taiwan without additional comparability study required using Taiwan reference drug.
The Solution
After reviewing the CMC, non-clinical and clinical similarity study data and reports and a briefing package, the team collaborated closely with the client and formulated relevant questions to ensure that the questions were clear and kept on point.
The EffPha team also met with CDE informally after submitting the consultation request to clarify the meeting purposes. After receiving CDE's written responses, we assisted in further discussion between the client and the CDE to ascertain the recommendations.
Results
With clear-cut questions and robust scientific evidence provided in the meeting package, the CDE was capable of evaluating the adequacy of the non-clinical and clinical data, and providing certain feedback and guidance on the different sources as selection of the reference listed drug (RLD) in their written response. We also guided the client on preparation of the drug manufacturing information to address the regulatory requirements for biosimilar registration in Taiwan based on the Agency’s recommendations.
Following the CDE consultation, the EffPha team prepared and submitted the biosimilar registration dossier and Plant Master File (PMF) applications to the Taiwan Food and Drug Administration (TFDA). Ultimately, the biosimilar successfully obtained marketing authorization and four PMF approvals from the TFDA.
The Challenge
A global pharmaceutical company reached out to EffPha for assistance in preparing and submitting a consultation request to the Center for Drug Evaluation (CDE) in Taiwan.
The client intended to seek approval of their biosimilar product in Taiwan, and had to determine an approved biological drug as the reference product of their biosimilar.
The client has completed a Phase 1 PK study using their biosimilar, US reference drug and EU reference drug. In addition, a Phase 3 study was conducted by the client to demonstrate similarity between the biosimilar and EU reference drug.
The primary challenge was to obtain the CDE’s agreement on the adequacy of the existing clinical data in support of biosimilar registration application in Taiwan without additional comparability study required using Taiwan reference drug.
The Solution
After reviewing the CMC, non-clinical and clinical similarity study data and reports and a briefing package, the team collaborated closely with the client and formulated relevant questions to ensure that the questions were clear and kept on point.
The EffPha team also met with CDE informally after submitting the consultation request to clarify the meeting purposes. After receiving CDE's written responses, we assisted in further discussion between the client and the CDE to ascertain the recommendations.
Results
With clear-cut questions and robust scientific evidence provided in the meeting package, the CDE was capable of evaluating the adequacy of the non-clinical and clinical data, and providing certain feedback and guidance on the different sources as selection of the reference listed drug (RLD) in their written response. We also guided the client on preparation of the drug manufacturing information to address the regulatory requirements for biosimilar registration in Taiwan based on the Agency’s recommendations.
Following the CDE consultation, the EffPha team prepared and submitted the biosimilar registration dossier and Plant Master File (PMF) applications to the Taiwan Food and Drug Administration (TFDA). Ultimately, the biosimilar successfully obtained marketing authorization and four PMF approvals from the TFDA.