Tags : Accord

Insights+

Insights+ Key Biosimilars Events of October 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency During the month of October, Henlius signed two agreements for its biosimilar products and presented results of HLX03 (biosimilar, adalimumab) whereas Samsung Bioepis and Biogen announced EMA filing acceptance of SB11 (biosimilar, ranibizumab) Our team at PharmaShots […]Read More

Insights+

Insights+ Key Biosimilars Events of September 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency. Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients. Hence, the providers are more likely to adopt biosimilars as a “reference […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (Sept 21-25, 2020)

Philips Launches QuickClear Mechanical Thrombectomy System for Blood Clot Removal Published: Sept 25,2020 | Tags: Philips, Launches, QuickClear Mechanical Thrombectomy System, Blood Clot Removal 2. BMS Reports Results of Opdivo (nivolumab) in P-III CheckMate -274 Study for Patients with High-Risk Muscle-Invasive Urothelial Carcinoma Published: Sept 25,2020 | Tags: BMS, Reports, Results, Opdivo, (nivolumab), P-III, CheckMate […]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

Insights+

Insights+ Key Biosimilars Events of July 2020

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Cadila expanded its footprints in India with the launch of its two biosimilars Bevaro (bevacizumab, biosimilar) and Ritucad (rituximab, biosimilar) Our team at PharmaShots has summarized 9 key events of the biosimilar space of July 2020 1. […]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