Aprogen to Hold FDA Meeting for Herceptin Biosimilar AP063 Approval
核心洞察
Aprogen (搜索) will hold a Type 2 Biological Product Development (BPD) meeting with the FDA next month to discuss Herceptin biosimilar AP063.
The meeting aims to confirm PPQ data for product approval, potentially shortening the approval timeline and saving costs for Aprogen (搜索).
Aprogen (搜索)'s perfusion-type culture process yields significantly higher antibody production compared to traditional methods, enhancing price competitiveness.
Aprogen (搜索), a company specializing in antibody drug development, announced it will hold a Type 2 Biological Product Development (BPD) meeting with the U.S. FDA next month regarding its Herceptin biosimilar, AP063. The meeting is a crucial step in securing product approval for AP063, which is currently undergoing trials in 150 hospitals across 15 countries, including Europe.
The primary objective of the BPD meeting is to confirm Process Performance Qualification (PPQ) data for the Herceptin biosimilar AP063. A successful meeting could significantly expedite the product permit application process and result in substantial cost savings for Aprogen (搜索). This meeting represents a pivotal moment in Aprogen's biosimilar business strategy, which aims to establish unparalleled price competitiveness through superior culture productivity.
Aprogen (搜索) distinguishes itself from most biosimilar developers by employing a perfusion-type culture process. According to the company, this method yields approximately 130 kilograms of antibodies from a single 2,000-liter incubator batch for the Herceptin biosimilar. For its Humira biosimilar, the yield exceeds 200 kilograms. This level of production is substantial, requiring only 6 or 7 refinements using a 1.8-meter diameter column, the largest refining equipment available for commercial use. Competitors using traditional pad placement processes would require approximately 4 to 6 15,000-liter incubators to achieve comparable output.
Prior meetings with the U.S. FDA and European EMA have resulted in the recognition of Aprogen (搜索)'s sub-batch refinement process as an independent drug substance (DS) batch, consisting of six sub-batches. During the upcoming BPD meeting, Aprogen aims to reaffirm with the FDA that product approval can be pursued using refined and finished PPQ data from only one or two sub-batches (out of six total) for each of the three culture batches. This approach would eliminate the need to generate PPQ data for all 18 sub-batches obtained from the three culture batches, leading to significant cost reductions and accelerated product approval timelines.
"As the U.S. FDA and the European EMA have already recognized sub-batch as an independent raw material drug placement two years ago, we expect to get the desired results at this meeting," a company official stated. "We have received the same answer from leading overseas consulting institutions."