Tags : Herzuma

Teva and Celltrion Launch Herzuma (biosimilar, trastuzumab) in the US

Shots: Teva and Celltrion report the availability of Herzuma (trastuzumab-pkrb), a biosimilar referencing Herceptin in the US. The biosimilar is designed to treat the same indications as to reference product relating to breast cancer and gastric cancer The drug will be available at WAC of $1,402.50 for a 150mg dosage and $3,927 for a 420mg […]Read More

Celltrion Signs an Exclusive Co-Marketing Agreement with Juno in Australia

Shots: Juno to provide sales promotion and hospital contracting services to Australian Hospital market customers and will co-market Herzuma (biosimilar, trastuzumab) and Truxima (biosimilar, rituximab) with Celltrion in Australia  The focus of the agreement is to market globally biosimilar brands to Australian Healthcare professionals and patients Herzuma (CT-P6, biosimilar, trastuzumab) is a mAb targeting the […]Read More

Teva Canada’s Herzuma (biosimilar, trastuzumab) Receives Health Canada Approval for

Shots: Health Canada has granted notice of compliance for Teva Canada’s Herzuma for the treatment of early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC) in Canada The Health Canada NOC is based on efficacy, safety, quality, immunogenicity, PK/PD data from non-clinical and clinical studies, demonstrating that Herzuma and Herceptin has […]Read More

Celltrion’s Herzuma (trastuzumab, biosimilar) Receives ANVISA’s Approval for Breast and

Shots: The Brazilian Health Regulatory Agency, ANVISA (Agencia Nacional de Vigilancia Sanitaria) has approved Herzuma (trastuzumab) in 150mg & 440mg for early-stage breast cancer, metastatic breast cancer and metastatic gastric cancer on May 20, 2019 Celltrion is also expecting ANVISA’s approval for Truxima, a biosimilar of Rituximab which helps in securing a leading market position […]Read More

Celltrion and Teva’s Herzuma (trastuzumab-pkrb, Herceptin biosimilar) Receives FDA’s Approval

Shots: The approval is based on non-inferiority data assessing Herzuma vs Herceptin (trastuzumab), testing its safety, efficacy, PK &PD, and immunogenicity The study demonstrated with bio-similarity in terms of purity, potency and safety between Herzuma and Herceptin in patients with HER2-overexpressing breast cancer Herceptin biosimilar, Herzuma (trastuzumab-pkrb) is a HER2/neu receptor antagonist, approved by the […]Read More

Celltrion’s Herzuma (Herceptin biosimilar) Receives Marketing Approval in Australia

Shots: Herzuma is first biosimilar approved in Australia for the treatment of early breast cancer, locally advanced or metastatic or advance gastric cancer Including Herzuma Celltrion has three biosimilar for Australia, Remsima for autoimmune disease, Truxima for blood cancer approved in Aug 2015 and April 2018 respectively Celltrion plans to launch Herzuma in Australia after […]Read More

Celltrion’s Herzuma (Trastuzumab Biosimilar, CT-P6) Receives EMA Approval for Breast

Shots: The approval is based on positive opinion by CHMP (EMA) assessing Herzuma and reference trastuzumab in patients with HER2 overexpression/gene amplification tumors in breast cancer, metastatic breast cancer and metastatic gastric cancer The study resulted in a non-inferiority data demonstrating efficacy, safety, immunogenicity, PD and PK in patients Herzuma (trastuzumab biosimilar, CT-P6) is a […]Read More