01 May 21 | Samsung Bioepis announced a new study demonstrating the structural, physicochemical and biological similarity between its SB11 (proposed ranibizumab biosimilar) and Lucentis...
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By Naomi Pearce | May 10, 2021
01 May 21 | Samsung Bioepis announced a new study demonstrating the structural, physicochemical and biological similarity between its SB11 (proposed ranibizumab biosimilar) and Lucentis...
By Bioblast Editor | May 06, 2021
Coherus BioSciences reported its Q1 2021 financial results. Coherus disclosed that it has commenced the rolling submission of the BLA for toripalimab and that it expects to file the BLA for CHS-201 (proposed ranibizumab biosimilar) mid-2021.
By Bioblast Editor | May 06, 2021
The Government of Alberta announced it has expanded its biosimilars switching program to include adalimumab for all originator indications except pediatric juvenial idiopathic arthritis. All adult patients on Humira® will be switched to Amgevita®, Hadlima®, Hulio®, Hyrimoz®...
By Naomi Pearce | May 05, 2021
Date: 5 May 2021Court: Full Court of the Federal Court of AustraliaJudges: Beach, Moshinsky and Thawley JJ
Background
Australian Patents AU2012304245 and AU2013100458 (P...
By Naomi Pearce | May 05, 2021
In light of the COVID-19 vaccine supply shortages in Australia, it was refreshing to hear NSW Premier Gladys Berejiklian announce yesterday that the NSW Government will establish go...
By Bioblast Editor | May 05, 2021
ThePrint reported that Hetero Labs has submitted an application to start clinical trials and manufacture of biosimilar tocilizumab in India. Tocilizumab has been recommended for off-label use in the treatment of COVID-19 by the Indian Government, but has been subject to ext...
By Bioblast Editor | May 04, 2021
Amgen launched Amgevita® (biosimilar adalimumab) in Canada. Amgevita® is available in 50mg/mL PFS and pen presentations and is citrate-free. Amgevita® will be reimbursed on the public drug plans in BC, Alberta, Ontario, Quebec, New Brunswick and Newfoundland.
By Naomi Pearce | May 03, 2021
23 April | Boehringer Ingelheim announced results from a Ph III switching study of Cyltezo® (biosimilar adalimumab) with Humira® produced similar clinical outcomes in terms of pharmacok...
By Bioblast Editor | May 03, 2021
Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside the US and Canada) reported the vision, focus and business model for its new standalone company, Organon. Merck & Co., Inc., disclosed that Organon with have a direct sales presence in 58 markets, with key gr...
By Bioblast Editor | May 03, 2021
Sandoz announced it will commence enrolling patients in MYLIGHT, its Ph III efficacy and safety study of its proposed aflibercept biosimilar. MYLIGHT will assess the efficacy and safety of the biosimilar candidate in comparison to Eylea® in patients with neovascular age-re...
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