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Merck INc., announced the U.S. launch of Ontruzant (trastuzumab-dttb), as a biosimilar of the reference biologic medicine Herceptin. Ontruzant is available in both 150 mg single-dose vials and 420 mg multiple-dose vials. Ontruzant will be introduced in the U.S. at a list price (wholesaler acquisition cost) of approximately $1,325 for the 150 mg single-dose vial and $3,709 for the 420 mg multiple-dose vial (prices are rounded), representing a 15% discount to the current list price of Herceptin.

Samsung Bioepis Co., Ltd. announced that the FDA has approved Ontruzant (trastuzumab-dttb), a biosimilar referencing Herceptin (trastuzumab), across all eligible...

EU approves Ontruzant (trastuzumab biosimilar).

Samsung Bioepis Co. Ltd. announced that Health Canada has approved Ontruzant (also known as SB3), a biosimilar referencing Herceptin (Trastuzumab), for the treatment of adults with Early Breast Cancer (EBC), Metastatic Breast Cancer (MBC) and metastatic gastric cancer (MGC).

Samsung Bioepis Co., Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has...

Breast cancer Metastatic breast cancer Ontruzant is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): - as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. - in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. - in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. - in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. Early breast cancer Ontruzant is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC). - following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1). - following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. - in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. - in combination with neoadjuvant chemotherapy followed by adjuvant Ontruzant therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter (see sections 4.4 and 5.1). Ontruzant should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1). Metastatic gastric cancer Ontruzant in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Ontruzant should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC3+ result. Accurate and validated assay methods should be used (see sections 4.4 and 5.1).

Breast cancer Metastatic breast cancer Ontruzant is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC): - as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. - in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. - in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease. - in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. Early breast cancer Ontruzant is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC). - following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable) (see section 5.1). - following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel. - in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. - in combination with neoadjuvant chemotherapy followed by adjuvant Ontruzant therapy, for locally advanced (including inflammatory) disease or tumours >2 cm in diameter (see sections 4.4 and 5.1). Ontruzant should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay (see sections 4.4 and 5.1). Metastatic gastric cancer Ontruzant in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Ontruzant should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC3+ result. Accurate and validated assay methods should be used (see sections 4.4 and 5.1).

Samsung Bioepis Co., Ltd. announced that the FDA has approved Hadlima (adalimumab-bwwd), a biosimilar referencing Humira (adalimumab) , for the...

Organon celebrates its launch as a global women’s health company with employees and women from around the world, as the Organon executive leadership team rings the opening bell at the New York Stock Exchange .