Hervelous (trastuzumab biosimilar) / Hanwha Solutions, Alvogen, Prestige BioPharma, Mundipharma, Dr. Reddy’s - LARVOL DELTA

Comparative Preclinical Evaluation of Tuznue Versus Referent Herceptin: A Registered Trastuzumab Biosimilar. (PubMed, Drugs R D) - "The comprehensive analytical characterization confirms the biosimilarity of Tuznue® to Herceptin®. This supports Tuznue® as a safe and effective alternative, offering a more affordable option for patients and healthcare systems. Biosimilar development requires overcoming inherent challenges, particularly when reference products exhibit variability in quality attributes over time. Regulatory guidance and scientific rigor are essential to ensuring biosimilar similarity, facilitating broader patient access to life-saving therapies."

Journal • Preclinical • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Prestige Biopharma swings to ₩32.1 bil. profit as Tuznue milestone payments roll in (Korea Biomedical Review) - "After years of development setbacks, Prestige Biopharma has crossed a major threshold, reporting its first-ever net profit-32.1 billion won ($22 million)-for the second half of 2024. The Korean antibody-based biosimilar maker, which has struggled to turn a profit since going public in 2021, also posted 2.1 billion won in revenue during the period, primarily fueled by milestone payments from Tuznue (trastuzumab), its Herceptin biosimilar. Operating loss narrowed to 54 billion won, a sharp improvement from the 200 billion won loss recorded a year earlier....The financial turnaround comes after Tuznue’s European approval last year. The company has already received an initial 1.7 billion won from a licensing partner, with more payments expected as sales ramp up across 30 European markets and beyond, including Russia, the Middle East, and South America."

Commercial • Gastric Cancer • HER2 Positive Breast Cancer

Prestige Biopharma and Dr. Reddy’s push Herceptin biosimilar into Brazil (Korea Biomedical Review) - "The Korean biosimilar developer said Tuesday that its partner, Dr. Reddy’s Laboratories, has submitted a marketing authorization application for Tuznue, its trastuzumab biosimilar, to Brazil’s National Health Surveillance Agency (Anvisa)....Tuznue, a biosimilar of Genentech’s blockbuster drug Herceptin, is approved for HER2-positive early breast cancer, metastatic breast cancer, and advanced gastric cancer....Prestige Biopharma said it expects a decision in 2025 and is working closely with Dr. Reddy’s to expedite the approval process....Regulatory applications are also under review in the Middle East and Russia, where final evaluations are ongoing."

Filing • Gastric Cancer • HER2 Positive Breast Cancer

Prestige Biologics signs 6.7 billion won supply contract for Tuznue raw pharmaceutical products [Google translation] (Medipana) - "Prestige Biologics...announced on the 10th that it had won a 6.7 billion won contract to supply the raw drug substance (DS) of 'Tuznue' from Prestige Biopharma. For a company that recorded sales of 2.1 billion won (June closing corporation) last year, this contract is 310% of the previous year's sales...This contract includes the cost of trial production and stability testing for 'Tuznue'...The parent company, Prestige Biopharma, has placed a minimum order in advance for final confirmation of the process and preparation for mass production ahead of signing a sales license-out with a European partner. With the stable supply of raw drug substances (DS), finished drug product (DP) production, which includes preparation, filling, inspection, and packaging, will proceed....As of this year, Prestige Biologics' DS production experience exceeded 100 batches."

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

Prestige Biopharma announced its goal of reaching a market cap of 30 trillion won in 6 years. [Google translation] (HIT News) - "Prestige Biopharma has 15 biosimilar pipelines and is about to receive approval for Tuznue, a Herceptin (ingredient: trastuzumab) biosimilar...Currently, Tuznue's partners are Doctor Redis, Tabuk, Cipla, and Pharmapark...'We expect to receive a total of 14.5 billion won in milestones from these companies based on approval and sales launch.'...'The list of European partner candidates has been narrowed down to about three out of eight partners.'....'We plan to receive accelerated approval from the U.S. Food and Drug Administration (FDA) for PBP1510 in 2028. We are targeting sales of KRW 2.48 trillion by 2030.'"

Financing • Sales projection • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Prestige BioPharma secures EC approval for Herceptin biosimilar Tuznue (Korea Biomedical Review) - "Prestige BioPharma, a Singapore-based biopharmaceutical company, said Monday that it has received final approval from the European Commission (EC) for its Herceptin biosimilar, Tuznue (ingredient: trastuzumab). Approval follows a recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on July 26. Tuznue is now positioned as a biosimilar to Herceptin, a treatment for breast cancer and metastatic gastric cancer, which commands an annual market value of approximately 5.5 trillion won ($4.1 billion)."

EMA approval • Gastric Cancer • HER2 Positive Breast Cancer

Prestige Biopharma "Expects to Sign European License Out Agreement" [Google translation] (Newspim) - "Prestige Biopharma dismissed concerns over the recent stock market plunge and announced on the 5th that it is in the process of negotiating a sales license out for the European region...Prestige Biopharma said that it currently has eight sales companies lined up for the sales license out in Europe and has begun the process of selecting a strong partner that can most quickly settle Tuznue into the market. The company explained that it is currently negotiating the contract terms because it is in an advantageous position to select a partner by taking advantage of Prestige Biologics’ unit price competitiveness with EU-GMP, given that CHMP has recommended approval...Prestige Biopharma will be revealed for the first time at the corporate briefing held at the Conrad Hotel in Yeouido on the 19th....In particular, the Tuznue sales strategy, CDMO business status, and the clinical progress of the world's first pancreatic cancer antibody new drug PBP1510 will be disclosed for the first time."

Clinical • Licensing / partnership • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Prestige BioPharma secures EMA's positive opinion for Herceptin biosimilar (Korea Biomedical Review) - "Prestige BioPharma said it received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for its Herceptin (ingredient: trastuzumab) biosimilar, Tuznue, intended for the treatment of breast cancer and metastatic gastric cancer...Following the CHMP's recommendation for marketing approval, Prestige BioPharma expects to receive authorization from the European Commission (EC) and launch the drug across 30 European countries starting this October...Tuznue, also known by its pipeline name HD201, has been licensed out to multinational pharmaceutical companies such as Dr. Reddy's, Tabuk Pharmaceuticals , Cipla, and Pharmapark....Upon final approval, Prestige BioPharma will receive milestone payments, marking the onset of its first sales."

Biosimilar launch • EMA approval • Financing • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Prestige Biologics launches '1st Quality Culture campaign' [Google translation] (eDaily) - "Prestige Biologics...is strengthening its quality management ahead of full-scale CDMO orders...Prestige Biologics, a biopharmaceutical contract development and manufacturing (CDMO) company, announced on the 10th that it successfully held the '1st Quality Culture Campaign' for all employees in the headquarters auditorium...This event by Prestige Biologics was held in anticipation of the approval of the first biosimilar product by its parent company, Prestige Biopharma. The recent issue of the US Biosecurity Act has led to a series of love calls from pharmaceutical and biotech companies, and the imminent start of full-scale operation of each plant has also become an opportunity to advance the launch of this quality culture campaign. As soon as the production of orders currently underway at Plant 1 is completed, the company plans to enter into contract manufacturing of biopharmaceuticals for global pharmaceutical and biotech companies along with the parent company's product, HD201."

Licensing / partnership • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Prestige Biopharma submits response to European product approval for 'HD201' [Google translation] (Nate) - "Prestige Biopharma...responded to the inquiry regarding the product approval application for 'HD201' from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) on the 2nd. It was announced on the 28th that a response was submitted....The European Medicines Agency's Drug User Advisory Committee sends an inquiry form required for approval review 120 or 180 days after the company applies for product approval. The company will submit a response, and the review process will stop until the response is submitted, which is called the 'stop clock' period. After 210 days, the Drug User Advisory Committee issues an opinion, and after 277 days, the European Medicines Agency confirms whether to approve the license."

EMA filing • Breast Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Prestige Biopharma expects first biosimilar approval between July and September [Google translation] (Nate) - "EMA receives ‘no grounds for rejection’ opinion; introduces 15 types of similar drugs and 16 types of new antibody drugs; Innovative New Drug Research Institute opens in September; expects to receive second order after Celltrion...Prestige Biopharma's first biosimilar approval has been given the green light. This is after receiving an opinion from the European Medicines Agency (EMA) stating that there are ‘no major problems’ with regard to the Herceptin biosimilar HD201...'We expect to know whether the product has been approved by July or September.'....If HD201 receives approval, it is expected to become Prestige Biopharma's first biosimilar."

CHMP • EMA approval • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

[VIRTUAL] A double-blind, randomized, parallel group study to demonstrate the equivalent pharmacokinetic properties of a single intravenous dose HD201, a trastuzumab biosimilar candidate, versus EU trastuzumab and US trastuzumab (ESMO 2020) - P1, P3 | "Legal entity responsible for the study: Prestige Pharma. Funding: Prestige Pharma."

Clinical • PK/PD data • Breast Cancer • Oncology • Solid Tumor

HD201: Analytical biocomparability and clinical trial progression of trastuzumab. (ASCO 2019) - "HD201 is demonstrated to be equivalent in analytical biocomparability and in clinical response, safety and PK profile to Herceptin in human study. Additional data for Pharmacokinetic from Troika trial will be reported in Asco meeting. Clinical trial information: 2012-000805-56."

Clinical

Final analysis of the phase III randomized clinical trial, comparing HD201 vs referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting (ESMO Asia 2022) - P3 | "Eligible patients received 4 cycles of docetaxel, 75 mg/m2, followed by 4 cycles of epirubicin, 75 mg/m2, and cyclophosphamide, 500 mg/m2 with either HD201 or referent trastuzumab (loading dose, 8 mg/kg; maintenance dose, 6 mg/kg) every 3 weeks in the neoadjuvant setting and then, 10 cycles of HD201 or referent trastuzumab after surgery, according to their initial randomization. During the post-treatment follow up period, AEs were reported for 64 (27.4%) and 72 (29.8%) patients in the HD201 and the referent trastuzumab groups respectively and no serious event was related to study treatment. Conclusions This final analysis of the TROIKA trial further confirms the comparable efficacy and safety of HD201 and referent trastuzumab."

Clinical • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Final analysis of the phase 3 randomized clinical trial comparing HD201 vs. referent trastuzumab in patients with ERBB2-positive breast cancer treated in the neoadjuvant setting. (PubMed, BMC Cancer) - P3 | "This final analysis of the TROIKA trial further confirms the comparable efficacy and safety of HD201 and trastuzumab."

Clinical • Journal • P3 data • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Tuznue: Withdrawal of the marketing authorisation application (European Medicines Agency) - "Prestige Biopharma Belgium BVBA withdrew its application for a marketing authorisation of Tuznue for the treatment of certain forms of breast cancer and gastric (stomach) cancer. The company withdrew the application on 14 September 2022."

European regulatory • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Hervelous: Withdrawal of the marketing authorisation application (European Medicines Agency) - "Prestige Biopharma Belgium BVBA withdrew its application for a marketing authorisation of Hervelous for the treatment of early breast cancer and breast cancer that has spread to other parts of the body. The company withdrew the application on 14 September 2022."

European regulatory • Breast Cancer • Oncology • Solid Tumor

Prestige Biopharma Submitted Pre-BLA Type 4 Meeting Request to FDA for Herceptin Biosimilar (Businesswire) - "Prestige Biopharma Limited...has submitted a request to the U.S. Food and Drug Administration (FDA) for a pre-submission meeting to discuss the company’s planned Biologics License Application (BLA) for its Herceptin Biosimilar, HD201(Tuznue)....The meeting is expected to take place around November, and the BLA submission by the end of the year....Currently, a New Drug Submission (NDS) for HD201 is under review by Health Canada and a Marketing Authorisation Application (MAA) by the Korea Ministry of Food and Drug Safety. In addition to filing a new MAA to the European Medicines Agency (EMA), the company also plans to apply for authorisation in other advanced biosimilars markets such as UK, Australia, and Singapore."

BLA • Canadian regulatory • FDA event • Non-US regulatory • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Prestige BioPharma voluntary withdraws EU license application for Herceptin biosimilar (Korea Biomedical Review) - "Prestige BioPharma said Thursday it has voluntarily withdrawn its European Medicines Agency (EMA) application for the re-examination of approving HD201 (brand name: Tuznue), a biosimilar referencing Herceptin to treat breast cancer and metastatic gastric cancer....The withdrawal comes after the company received a negative opinion on the marketing authorization for HD201 from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on May 19....However, even in the re-examination, the company was not able to resolve the opinion difference with CHMP in six out of the 46 EMA’s equivalence analyses criteria and decided to withdraw its application. The company plans to apply for marketing approval again by adding test and analysis data to meet the criteria for equivalence analysis required by CHMP."

European regulatory • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Prestige BioPharma’s Herceptin biosimilar fails to get European permit (Korea Biomedical Review) - "Prestige BioPharma, a Singapore-based company, listed on the Kospi market, said it failed to get marketing approval for its Herceptin biosimilar product in Europe. The company’s stock price tanked immediately after the announcement. In a public disclosure on Friday, Prestige BioPharma said it received a negative opinion on the marketing authorization for HD201 (brand name: Tuznue), a Herceptin biosimilar from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on Thursday....'The company plans to apply for a re-examination of HD201 to the EMA'."

European regulatory • Stock price • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

TROIKA: A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients (clinicaltrials.gov) - P3 | N=503 | Completed | Sponsor: Prestige Biopharma Limited | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

The Result of the Phase 3 Study for Prestige BioPharma’s Herceptin Biosimilar, HD201(Tuznue), Published in JAMA Oncology (Businesswire) - P3 | N=500 | TROIKA (NCT03013504) | Sponsor: Prestige Biopharma Limited | "Prestige BioPharma...announced positive efficacy and safety results of the Phase 3 study for HD201 (TROIKA)...The study met its primary endpoint (tpCR) and showed equivalent efficacy and comparable safety profile. The tpCR rates were 45% and 48.7% for HD201 and referent trastuzumab, respectively. The difference between the two groups was not significant at −3.8% (95% CI, −12.8% to 5.4%) and fell within the predefined equivalence margins...The final analysis for the 3-year Event-free survival (EFS) and Overall survival (OS) results is currently ongoing. The preliminary results of the current final analysis indicate highly comparable 3-year EFS and OS rates for HD201 and reference trastuzumab."

P3 data • Oncology

Efficacy of HD201 vs Referent Trastuzumab in Patients With ERBB2-Positive Breast Cancer Treated in the Neoadjuvant Setting: A Multicenter Phase 3 Randomized Clinical Trial. (PubMed, JAMA Oncol) - P3 | "Patients with ERBB2-positive early breast cancer were randomly assigned to receive HD201 or referent trastuzumab in the neoadjuvant setting for 8 cycles, concurrently with 4 cycles of docetaxel, which was followed by 4 cycles of epirubicin and cyclophosphamide. The results of this randomized clinical trial found that HD201 demonstrated equivalence to referent trastuzumab in terms of efficacy for the end point of tpCR, with a similar safety profile. ClinicalTrials.gov Identifier: NCT03013504."

Clinical • Journal • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

"Prestige BioPharma’s Herceptin Biosimilar, Tuznue®, Receives EU-GMP Certification https://t.co/AemlQXimRT" (@NewsFromBW)

Prestige BioPharma’s Herceptin Biosimilar, Tuznue, Receives EU-GMP Certification (Businesswire) - "Prestige BioPharma Limited...announced that the manufacturing facility for its Herceptin® biosimilar, Tuznue®, in Prestige Biologics Co., Ltd. (334970: KOSDAQ), has received European Union Good Manufacturing Practices (GMP) certification. EU-GMP certification is one of the highest standards of pharmaceutical production in the world, and it provides pharmaceuticals with the foundation to start selling their products into European markets."

European regulatory • Breast Cancer • HER2 Positive Breast Cancer • Oncology