AP06 (trastuzumab biosimilar) / Aprogen - LARVOL DELTA

At a pre-BLA meeting with the U.S. Food and Drug Administration (FDA), Aprogen announced on the 8th that it has secured the FDA's judgment that the Herceptin (Trastuzumab) biosimilar "AP063" can be developed based on analysis data, clinical pharmacokinetics (PK), and immunogenicity evaluation without confirmatory phase 3 clinical trials. (Maeil Business Newpaper) - "Following the EMA, the FDA confirmed its regulatory judgment that biosimilar verification is possible without phase 3 clinical trials, further increasing the predictability of AP063's global product approval strategy....The FDA comprehensively reviewed the Phase 1 clinical results submitted by Aprogen, analytical equivalence data, pharmacokinetics (PK), and immunogenicity data. As a result, it was suggested that additional phase 3 clinical trials were not required. Accordingly, the final appropriateness of the approach will be determined during the review process of the Biologics License Application for actual sales."

FDA event • Breast Cancer

Aprogen announced on the 12th that it is accelerating the global development of biosimilars and new drug pipelines, expanding CMO (consignment production) and CDMO (consignment development production) capabilities, and speeding up the leap forward of global bio companies (Maeil Business Newpaper) - "In particular, as major pipelines such as Herceptin and Humira biosimilars and immuno-cancer drugs 'PMC-309' are materialized, expectations for copyright contracts and licenses are growing in the future....Herceptin biosimilar 'AP-063' has reorganized its development strategy in line with changes in the global regulatory environment....Humira biosimilar 'AP-096' is also in the final stages of preparation for entering the global market."

Commercial • Breast Cancer • Colorectal Cancer • Melanoma • Mesothelioma

Aprogen meets with U.S. FDA BPD next month for Herceptin biosimilar (Pulse by Maeil Business News Korea) - "Aprogen...announced on the 21st that it will hold a Type 2 Biological Product Development (BPD) meeting with the U.S. FDA next month...The preliminary meeting is aimed at confirming PPQ (Process Performance Qualification) data for application for product approval for Herceptin biosimilar AP063, which is being pursued in 150 hospitals in 15 countries, including Europe. If the meeting is successful, the company expects Aprogen to significantly shorten the time for applying for product permits and save a lot of money...At this BPD meeting, the company will be reaffirmed by the FDA about applying for product approval only with refined and finished PPQ data for one or two sub-batches (total of three or six sub-batches) for each of the three batches of culture. In this way, Aprogen does not need to make PPQ data for all 18 sub-batch obtained from the 3rd batch of culture, which can greatly save costs and greatly accelerate the time of product approval."

FDA event • Breast Cancer • Oncology • Solid Tumor

[HITAlgong] Hanall Biopharma introduces antibody discovery platform technology [Google translation] (HIT News) - "Aprogen Biologics conducted a paid-in capital increase worth approximately 55.7 billion won. The amount will be used to repay debt to the parent company, Aprogen, and Aprogen plans to receive repayment of the loan and use it for the cost of the global phase 3 clinical trial of Herceptin (HER2-positive breast cancer anticancer drug) biosimilar (project name: AP063)."

Financing • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Aprogen, ‘Herceptin’ similar approved for European EMA phase 3 clinical trial [Google translation] (BioTimes) - "Aprogen...announced on the 12th that it has received approval from the European Medicines Agency (EMA) for the phase 3 clinical trial of AP063, a Herceptin biosimilar it is developing...This phase 3 clinical trial will be conducted as a global clinical trial in over 150 hospitals in 15 countries around the world using a random assignment, double-blind, parallel design equivalence method...The number of patients participating in the clinical trial is 720, and the treatment period is 54 weeks. The main purpose of the clinical trial is to compare the effectiveness, safety, and immunogenicity of AP063 with the original drug Herceptin...The clinical trial will be conducted by Syneos Health...and Catalent in the U.S. will be responsible for supplying test drugs and control drugs....Through this clinical trial, Aprogen aims to expand the scope of indications to not only HER2-positive breast cancer but also metastatic gastric cancer, for which the original Herceptin was approved."

New P3 trial • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

[HITRGong] Aprogen, Herceptin biosimilar approved for phase 3 clinical trial in India [Google translation] (HIT News) - "Aprogen announced on the 5th that it received approval for the phase 3 clinical trial plan for AP063. The region other than Europe is India, and the total number of clinical trial subjects is 720. The target disease name is HER2-positive breast cancer, and the purpose of the clinical trial is to compare the effectiveness, safety, and immunogenicity between AP063 and Herceptin."

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Aprogen Applies for Phase 3 Clinical Trial of Herceptin Biosimilar in India [Google translation] (HIT News) - "Aprogen Applies for Phase 3 Clinical Trial of Herceptin Biosimilar in India = Aprogen announced on the 24th that it has applied for a Phase 3 clinical trial plan in India for its Herceptin biosimilar 'AP063 (development code name)'. The trial was titled 'A randomized, double-blind, parallel-design, equivalence, multicenter Phase III trial to compare the efficacy, safety, and immunogenicity of AP063 to Herceptin in patients with HER2-positive breast cancer.'"

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Aprogen 'FDA∙EMA recognizes AP063 phase 3 clinical trial 'sub batch' as ​​independent batch' [Google translation] (HIT News) - "Aprogen...received a sub-batch approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the Phase 3 clinical trial drug 'AP063 (development code name)', a Herceptin biosimilar currently under development. It was announced on the 31st that Batch) was recognized as an independent batch...The company explains that this is the first clinical drug to be purified by dividing one culture batch into six sub-batches....According to the company, AP063 needs to be produced in large quantities, approximately 120 kg (based on the amount of antibodies in the recovered culture), through one culture in a 2000 liter incubator, so the largest commercially available purification equipment (1.8 m diameter column) was used. It must be divided into 6 parts and processed 6 times."

European regulatory • FDA event • Oncology

Aprogen applies for phase 3 clinical trial of AP063 to the European Medicines Agency [Google translation] (Maekyung Media Group) - "Aprogen...announced on the 27th that it had submitted an application for a phase 3 clinical trial for AP063, a Herceptin biosimilar it is developing, to the European Medicines Agency (EMA)....This phase 3 clinical trial is a test to compare the effectiveness, safety, and immunogenicity of AP063 with the original drug, Herceptin, in HER2-positive breast cancer patients. The clinical trial will be conducted in 147 hospitals around the world using a randomized, double-blind, parallel design equivalence method. Syneos, the U.S. clinical trial agency, has completed detailed discussions with 147 hospitals regarding the clinical trial. The number of patients in the clinical trial is 720, and the treatment period is 54 weeks."

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Nichi-Iko quits Herceptin biosimilar, focus now on Avastin follow-on (Pharma Japan) - "Japanese generic major Nichi-Iko Pharmaceutical said on January 17 that it will discontinue its Herceptin (trastuzumab) biosimilar program, which has been in PI in the US, as it now wants to sharpen its focus on its Avastin (bevacizumab) follow-on..."

Discontinued