Lead Product(s) : Trastuzumab,Docetaxel,Epirubicin Hydrochloride
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Prestige Biopharma's Herceptin Biosimilar Tuznue® Receives Positive CHMP Opinion
Details : Tuznue (trastuzumab-biosimilar) is a HER2/neu receptor antagonist, which is indicatedfor the treatment of HER2 overexpressing breast cancer & metastatic gastric adenocarcinoma.
Product Name : Tuznue
Product Type : Antibody
Upfront Cash : Inapplicable
July 31, 2024
Lead Product(s) : Trastuzumab,Docetaxel,Epirubicin Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Trastuzumab
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Prestige Biopharma Submitted Pre-BLA Type 4 Meeting Request to FDA for Herceptin Biosimilar
Details : Tuznue (trastuzumab) targets HER2, which is overexpressed in some types of cancer cells and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.
Product Name : Tuznue
Product Type : Antibody
Upfront Cash : Inapplicable
October 13, 2022
Lead Product(s) : Trastuzumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Bevacizumab
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Intas Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Partnership
Details : Prestige´s bevacizumab (HD204) is a mAb biosimilar to Roche’s Avastin®, an inhibitor of vascular endothelial growth factor (VEGF), which is used in combination with other therapies to treat patients with multiple forms of cancer.
Product Name : HD204
Product Type : Antibody
Upfront Cash : Undisclosed
July 26, 2022
Lead Product(s) : Bevacizumab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Intas Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Partnership
Lead Product(s) : Trastuzumab,Docetaxel,Epirubicin Hydrochloride
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The study met its primary endpoint (tpCR) and showed equivalent efficacy and comparable safety profile for Troika (HD201), a biosimilar to Herceptin® (trastuzumab), for the treatment of HER2 positive breast and metastatic gastric cancer.
Product Name : Tuznue
Product Type : Antibody
Upfront Cash : Inapplicable
March 14, 2022
Lead Product(s) : Trastuzumab,Docetaxel,Epirubicin Hydrochloride
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Trastuzumab,Docetaxel
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Dr. Reddy's Laboratories
Deal Size : Undisclosed
Deal Type : Partnership
Details : Under this partnership, Prestige BioPharma will be responsible for sustainable commercial supply of HD201 from its manufacturing facilities in Osong, South Korea, while Dr. Reddy’s will be responsible for local registrations, marketing and sales in the...
Product Name : Tuznue
Product Type : Antibody
Upfront Cash : Undisclosed
September 12, 2021
Lead Product(s) : Trastuzumab,Docetaxel
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Dr. Reddy's Laboratories
Deal Size : Undisclosed
Deal Type : Partnership
Lead Product(s) : Bevacizumab,Carboplatin,Paclitaxel
Therapeutic Area : Oncology
Study Phase : Phase III
Sponsor : Pharmapark
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Details : The partnership arrangement includes the exclusive rights for Pharmapark to commercialize the Bevacizumab biosimilar in the Russian Federation, leveraging the company’s strong sales and marketing capabilities and experience in successfully bringing new...
Product Name : HD204
Product Type : Antibody
Upfront Cash : Undisclosed
April 15, 2021
Lead Product(s) : Bevacizumab,Carboplatin,Paclitaxel
Therapeutic Area : Oncology
Highest Development Status : Phase III
Sponsor : Pharmapark
Deal Size : Undisclosed
Deal Type : Licensing Agreement