Adalimumab biosimilar(Prestige BioPharma Ltd.)

Prestige BioPharma Limited (950210: KRX), a Singapore-based biopharmaceutical with operations in USA and South Korea, announced positive efficacy and safety results of the Phase 3 study for HD201 (TROIKA), a biosimilar to Herceptin® (trastuzumab), published in JAMA Oncology on March 4, 2022. The publication highlights comparative efficacy and safety data for patients who received 1-year of treatment with HD201 or referent trastuzumab and completed a median follow-up of 31 months. 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 results regarding secondary endpoints bpCR, overall response, and response based on mammography, ultrasonography, or clinical tumor evaluations supported the comparable efficacy between HD201 and referent trastuzumab. Similar safety, PK and immunogenicity results were reported for the two treatment arms. 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. Tuznue® has secured global distribution partnerships in major markets including Europe, the Middle East, South America, and Asia. It is currently under Marketing Authorization Application (MAA) review in EU EMA, Canada and South Korea. Prestige’s robust pipeline in clinical stage also includes an Avastin biosimilar HD204 (Vasforda®) in global Phase 3, and a Humira biosimilar PBP1502 in Phase 1 clinical trial in Europe. Lisa S. Park, CEO of Prestige BioPharma, commented: “We are pleased to demonstrate HD201’s excellence through the Phase 3 study results published in JAMA Oncology” and “the company will accelerate global launch of Tuznue that can enhance affordability of trastuzumab to the patients in need”.

Prestige BioPharma and Pharmapark LLC announced that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige BioPharma´s Trastuzumab biosimilar in the Russian Federation. SINGAPORE, July 08, 2019 / B3C newswire / -- Prestige BioPharma and Pharmapark LLC today announced that the two companies have entered into a binding agreement for the exclusive partnership and supply for the commercialization of Prestige BioPharma´s Trastuzumab biosimilar in the Russian Federation. Prestige´s Trastuzumab is a mAb biosimilar to Roche’s Herceptin®, which is used to treat patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. The product has recently been accepted for review at the European Medicines Agency (EMA), based on excellent clinical results achieved with regard to the products´ safety and efficacy pro to Herceptin®. The partnership arrangement includes the exclusive rights for Pharmapark to commercialize the Trastuzumab biosimilar in the Russian Federation, leveraging the company’s strong sales and marketing capabilities and experience in successfully bringing new biosimilars to market. Whilst the terms of the deal are not being disclosed, Prestige BioPharma will assume responsibility for product commercial supply out of its manufacturing facilities in Osong, Korea, while Pharmapark will be responsible for local registration, sales and marketing in the Russian Federation with the option to manufacture the product in Russian Federation in line with the Russian import substitution strategy. Lisa S. Park, CEO of Prestige BioPharma, commented : “We are very pleased to partner with Pharmapark to commercialize our lead biosimilar program in Russian Federation. We are excited to bring our high-quality product to another key market with the ultimate goal to make the product available globally.“ Vasily Skrypin, CEO of Pharmapark, commented: “The partnership with Prestige BioPharma demonstrates the successful execution of our strategy and marks a further milestone for our company as we work to expand our existing pipeline of biosimilars for the Russian and CIS markets. We are excited about the opportunity of bringing an additional biosimilar product to our market that would provide a new safe and effective treatment option for our citizens.” About Prestige BioPharma Prestige BioPharma is a Singapore-based biopharmaceutical company focusing on the development of biosimilars and new antibody therapeutics. Its lead program, HD201 trastuzumab biosimilar, has been filed with EMA and will also be filed with USFDA in 2019. Prestige BioPharma´s next products in line include a Bevacizumab biosimilar (HD204) in Phase III, an Adalimumab biosimilar (PBP1502) in Phase I and an innovative anti-PAUF mAb (PBP1510) for the treatment of pancreatic cancer in preclinical stages. Manufacturing facilities for global commercial supply are located in Osong, South Korea. For more, please visit , or click on Facebook , LinkedIn . About Pharmapark LLC Pharmapark is a privately-owned Russian biopharmaceutical company that is focused on development, manufacture and commercialization of biosimilar products. The company possesses the know-how and has a successful track record performing complete biotechnological drug development through commercial production. Pharmapark successfully market 5 biosimilar products and has in-house pipeline of novel formulations and biosimilars focused on value-adding treatments. Contacts Prestige BioPharma Global Communication Team Ms. Felicia Ang +65 6924-6535 info@pbpsg.com Pharmapark LLC Vyacheslav Lebedyansky Chief Operating Officer +7 903 726 17 81 lebedyansky@pharmapark.ru