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EirGenix announced positive Ph III results for trastuzumab biosimilar
EirGenix announced that its Ph III clinical trial of EG12014 (proposed trastuzumab biosimilar) has met its primary endpoint. EirGenix announced that EG12014 has shown equivalent efficacy to Herceptin®, and demonstrated a comparable safety profile.
Herzuma® gains 44% market share in Japan
The Korea Herald reported that Celltrion’s Herzuma® (biosimilar trastuzumab) reached a 44% market share in Japan last year.
Tabuk partners with Prestige on Tuznue®(biosimilar trastuzumab)
Saudi Arabia’s Tabuk Pharmaceuticals announced it has reached an exclusive licensing and distribution agreement with Korea’s Prestige Biopharma for the commercialisation of Tuznue® (biosimilar trastuzumab). Under the agreement, Tabuk will receive exclusive rights to commercialise and distribute Tuznue® in the Middle-East and North Africa region.
Roche reports huge erosion of YoY CER growth in key areas
Roche reports a huge erosion of its year on year CER growth in key areas, attributing this decline to COVID-19 impacts and biosimilars. Roche reported the YoY CER growth of Avastin (bevacizumab) was -25%, with the hematology franchise (including rituximab) at -22% and HER2 franchise (including trastuzumab and pertuzumab) at -8%.
Strong uptake of Amgen’s Kanjinti® (biosimilar trastuzumab) in Europe
New study demonstrates increased usage of trastuzumab biosimilars
The Centre for Biosimilars reports a new study indicates dramatically increased usage of trastuzumab biosimilars in the US. The study presented at the San Antonio Breast Cancer Symposium indicated that biosimilar use increased based on payer policies that favored biosimilars.
Prestige BioPharma and Teva Israel exclusive partnership and supply agreement for Prestige’s Tuznue®
Prestige BioPharma and Teva Israel announce they have entered into an exclusive partnership and supply agreement for Prestige’s Tuznue® (trastuzumab biosimilar) in Israel. Under the agreement, Prestige is responsible for registration and commercial supply, and Teva Israel will be responsible for local registration, sales and marketing in Israel.
Celltrio signs contract to provide Herzuma® and Truxima® to Brazilian Federal Government
Korea Biomedical Review reports Celltrion has signed a contract to provide Herzuma® (biosimilar trastuzumab) and Truxima® (biosimilar rituximab) to the Brazilian Federal Government. Celltrion has also signed a contract to provide Truxima® to the Sao Paulo Provincial Government.
Results from Centre for Biosimilars studies for HD201 released
The Centre for Biosimilars reports two new studies for HD201 (Prestige Biopharma’s proposed trastuzumab biosimilar) were presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology. The first study, TROIKA-I demonstrated that HD201 was safe and well tolerated with PK comparability to the originator. The second, TROIKA was designed to compare safety, PK and efficacy based on the total pathological complete response rate. The investigators reported that the studies demonstrated equivalence between the biosimilar and reference products.
Accord Healthcare launches Zercepac® in UK
Accord Healthcare launches Zercepac® (biosimilar trastuzumab) in the UK. Zercepac® is indicated for HER2-positive early breast cancer, HER2-positive metastatic breast cancer and previously untreated HER2-positive metastatic gastric cancer and is available in a 150mg single-dose vial.
Shanghai Henlius Biotech trastuzumab biosimilar Zercepac® approved
Shanghai Henlius Biotech announces China’s NMPA has approved its trastuzumab biosimilar Zercepac®. Zercepac® is indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.
Samsung Bioepis launches Ontruzant®
Samsung Bioepis launches Ontruzant® (biosimilar trastuzumab) in Brazil. Ontruzant® is indicated for the treatment of metastatic HER2-overexpressing breast cancer, early HER2-overexpressing breast cancer, and advanced gastric cancer.
Celltrion trastuzumab biosimilar Herzuma® gains WHO prequalification
Celltrion gains WHO prequalification for its trastuzumab biosimilar Herzuma®. The prequalification status enables Celltrion to make a bid in global procurement by UN agencies, and is based on an evaluation of safety and efficacy.
Shanghai Henlius Biotech and Accord Healthcare announce EC approval of Zercepac®
Shanghai Henlius Biotech and Accord Healthcare jointly announce the European Commission has approved Zercepac® (biosimilar trastuzumab) for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.
Results from study on Herzuma® released by Journal of Clinical Pathways
The Journal of Clinical Pathways report a new study shows a triplet regimen of pembrolizumab, Herzuma® (biosimilar trastuzumab) and chemotherapy is effective in patients with HER-2 positive advanced gastric cancer.
Genentech and Amgen file stipulations for dismissal of BPCIA litigation
Genentech and Amgen file stipulations in the US District Court of Delaware dismissing their BPCIA litigation relating to trastuzumab and bevacizumab biosimilars. This comes after the Court of Appeals refused to block Amgen’s Mvasi® from entering US markets on July 06.
CHMP recommends marketing authorisation for Henlius Biotech HLX02
Henlius Biotech announces it has received a positive CHMP opinion, recommending marketing authorisation for HLX02 (proposed trastuzumab biosimilar).
Henlius Biotech adalimumab and trastuzumab under New Drug Application review
Henlius Biotech announces that its adalimumab and trastuzumab products are under New Drug Application review, with the potential to be launched in 2020.
Results from Samsung Bioepis study on Ontruzant® released
Samsung Bioepis announces the results of a four year follow up study of Ontruzant® (trastuzumab) will be presented at the ASCO20 Virtual Scientific Program organized by the American Society of Clinical Oncology (ASCO) at the end of this month. The study assessed the cardiac safety and surival outcome in a subgroup of patients from the Ph III study.
Biocon manufacturing practice compliance recognised
Biocon receives good manufacturing practice compliance certificate from the EMA for Bengaluru facilities.
Henlius Biotech receives EU GMP certificates for trastuzumab biosimilar
Henlius Biotech announces it has received two EU GMP certificates related to its trastuzumab biosimilar HLX02.
Merck and Samsung Bioepis Ontruzant® launches in the US
Merck and Samsung Bioepis launch Ontruzant® (trastuzumab) in the US. Ontruzant® is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative breast cancer as part of a treatment regimen and as a single agent following multi-modality anthracycline based therapy.
Biocad receives registration certificates for Acellbia® and Herticad®
Biocad announces it has received registration certificates from Bosnia and Herzegovina for Acellbia® (rituximab) and Herticad® (trastuzumab), with a launch expected in 2020.
FDA approves Samsung Bioepis mutli-dose vial Ontruzant®
Samsung Bioepis announces the FDA has approved its 420mg multi-dose vial of Ontruzant® (trastuzumab).
Product specific reports based on extracts from our BioBlast® database
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