Pearce IP BioBlast®: w/e 11 March 2022

by , | Mar 11, 2022

03 Mar 22 | US | FDA announced a new funding opportunity for the BsUFA III Regulatory Science Program to support research projects that “enhance biosimilar and interchangeable biological product development and regulatory science”.

07 Mar 22 | Merck published interim results from its Ph III trial of Keytruda® (pembrolizumab) as an adjuvant treatment for patients with stage IIB and IIC melanoma.  According to the announcement, the trial met its key secondary endpoint and showed an improvement in recurrent-free survival compared to placebo.

08 Mar 22 | US | Alvotech announced that it has settled all pending US disputes with AbbVie, including the ITC case brought by AbbVie in December 2021.  Under the settlement Alvotech will receive non-exclusive rights to market AVT02 (high-concentration, citrate-free biosimilar adalimumab) in the United States from 1 July 2023.  This date is the same US license date AbbVie granted to Coherus and Boehringer Ingelheim in their respective settlements with AbbVie, which follows Amgen’s US license date of 31 Jan 23 and Samsung’s 30 June 2023.  Alvotech is the only known company that has both developed a high-concentration biosimilar adalimumab and conducted switching studies to enable the launch of what is expected to be the first high concentration interchangeable biosimilar adalimumab in the US.  Teva is Alvotech’s strategic partner for the US commercialisation of AVT02.  AVT02 is already approved in Europe, Canada and the UK.

08 Mar 22 | Prestige BioPharma published preclinical data on its first-in-class pancreatic cancer treatment PBP1510 (ulenistamab).  PBP1510 is being developed as a potential treatment for pancreatic cancer and is currently in Ph 1/2a trials in France and Spain.

10 Mar 22 | CA | Samsung Bioepis and Biogen announced that Health Canada approved Byooviz™ (biosimilar ranibizumab) on 8 March for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO), choroidal neovascularization (CNV) secondary to pathologic myopia (PM) and choroidal neovascularization (CNV) secondary to ocular conditions other than AMD or PM.  This is the first Health Canada approval of a biosimilar ranibizumab to date, and whilst is it Samsung’s 6th Canadian biosimilar, it is Biogen’s first.  Byooviz™ was approved in the US in September 2021, and in the EU and the UK in August 21.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email info@pearceIP.law.

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