Tags : trastuzumab

Regulatory

Daiichi Sankyo and AZ’s Trastuzumab Deruxtecan Receives CHMP’s Recommendation for

Shots: The recommendation is based on a P-II DESTINY-Breast01 study assessing trastuzumab deruxtecan in patients with HER2 positive unresectable/ m-BC prior treated with trastuzumab emtansine The trial demonstrated a meaningful & durable activity in patients who had received two or more prior anti-HER2 therapies. The safety & tolerability profile of the therapy was consistent with […]Read More

Biosimilars

Prestige Signs an Exclusive Agreement with Teva to Commercialize Tuznue

Shots: Teva to get an exclusive right to commercialize Tuznu in Israel, leveraging its marketing capabilities and experience in bringing pharmaceutical products to market and will be responsible for local registration, sales, and marketing in Israel Prestige will assume responsibility for product registration with the EMA and commercial supply of Tuznue from its manufacturing facilities […]Read More

Biosimilars

Accord Launches Zercepac (biosimilar, trastuzumab) in the UK

Shots: Accord launches Zercepac as s a biosimilar referencing Herceptin in the UK, following the EC’s approval in Jul’2020. The EC’s approval is based on a series of robust studies including comparative quality studies, pre/ clinical studies. The results confirmed the Zercepac’s bio-similarity, demonstrating comparable efficacy and safety to the Herceptin Zercepac is the first […]Read More

Biosimilars

Henlius’ HLX02 Receives the NMPA’s Approval as the First Trastuzumab

Shots: On Aug 14, 2020, HLX02 (biosimilar, trastuzumab) received NMPA’s approval to treat HER2+ early BC, HER2+ m-BC and HER2+ m-gastric cancer. Additionally, On 27th July, HLX02 has received EC’s approval under the brand name Zercepac Henlius followed the NMPA and EMA’s biosimilar guidelines and has taken multiple head-to-head comparisons b/w HLX02 and the reference, […]Read More

Biosimilars

Samsung Bioepis Launches Ontruzant (trastuzumab, biosimilar) for Early and Metastatic

Shots: The company launches its first oncology treatment Ontruzant (trastuzumab), a biosimilar referencing Herceptin in Brazil. The biosimilar has received ANVISA’s approval for the treatment of metastatic HER2-overexpressing BC, early HER2-overexpressing BC, and advanced gastric cancer Ontruzant is being supplied to SUS through a PDP b/w Samsung Bioepis & Bionovis and Bio-Manguinhos. This the second […]Read More

Biosimilars Regulatory

Henlius and Accord’s Zercepac (trastuzumab, biosimilar) Receive the EMA Approval

Shots: The approval is based on comparative quality studies, clinical studies including preclinical data and resulted in bio-similarity, comparable efficacy and safety of Zercepac (HLX02) vs Herceptin Zercepac is developed under NMPA and EMA biosimilar guidelines and has been evaluated with the reference trastuzumab including comparative quality studies, preclinical studies, a P-I clinical study and […]Read More

Biosimilars

Henlius and Accord Receive CHMP’s Positive Opinion for its HLX02

Shots: The EMA’s CHMP has granted a positive opinion, recommending marketing authorization for HLX02 to treat HER2+ early breast cancer, HER2+ metastatic breast cancer & previously untreated HER2+ metastatic adenocarcinoma of the stomach or gastro-esophageal junction EC will now review the CHMP’s positive opinion, with the expected regulatory decision in next 2-3mos. Once approved, a […]Read More