Shots: The CHMP has granted positive opinion to Tuznue, a biosimilar version of Herceptin (trastuzumab) for the treatment of HER2+ve early & metastatic breast cancer as well as HER2+ve metastatic gastric cancer The recommendation was supported by the data showing similarity b/w Tuznue vs Herceptin under P-I & P-III trials to evaluate the PK profile,…
Shots: Accord BioPharma's Hercessi (trastuzumab-strf; 150mg; IV), a biosimilar to Herceptin (trastuzumab), has been approved by the US FDA to treat HER2 overexpressing breast and G/GEJ cancer in the US The approval was based on 2 studies incl. P-I (HLX02-HV01 & HLX02-HV02) trial assessing the single-dose, PK equivalence in healthy volunteers. P-III (HLX02-BC01) trial assessing…
Shots: Under the terms of the agreement, Sandoz received the exclusive right to commercialize and distribute Ogivri, the biosimilar version of Herceptin & Abevmy, the biosimilar version of Avastin, across Australia for the treatment of various cancer indications Additionally, Sandoz AG will be held responsible to distribute Biocon’s biosimilar versions of trastuzumab and bevacizumab across Australia…
Shots :The US FDA has accepted the BLA for DMB-3115 based on the results from P-III multi-regional studies for treating plaque psoriasis having rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms as its 1EP. The results showed similar quality, safety and efficacy between DMB-3115 vs Stelara Accord BioPharma…
Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyFresenius Kabi expanded its footprints with the acceptance of MAA and BLA of its MSB11455 (biosimilar, pegfilgrastim) in the EU and the US respectively, and also signed an agreement with Medec to commercialize Idacio (adalimumab, biosimilar) in…

