Significant biosimilar activities this week include: 01 March 2023 | CA | Study finds nonmedical switching policy did not negatively impact patients A new study published in...
A central tenet of patent interpretation under Australian law is that the specification should be a given a purposive construction rather than a purely literal one. While this...
Significant biosimilar activities this week include: 09 March 2023 | EU | Sandoz signs MOU for USD$400M biologics facility Novartis announced that Sandoz signed an MOU to build...
In this patent infringement/validity dispute, Hanwha failed to establish that REC infringed its “old Act” Australian patent No 2008323025, and its dependant ACL claims were dismissed.
Significant biosimilar activities this week include: 28 February 2023 | IN | Enzene Biosciences begins supply of Humira® (adalimumab) biosimilar in India Biospectrum...
Significant biosimilar activities this week include: 22 February 2023 | EU | AbbVie sued by Dutch group over Humira® pricing The Financial Times has reported that the Dutch...
In this patent infringement/validity dispute, Hanwha failed to establish that REC infringed its “old Act” Australian patent No 2008323025, and its dependant ACL claims were dismissed.
Pearce IP proudly welcomed Donna Meredith (Patent & Trade Mark Attorney) this month. Donna has incredible pedigree and experience at big law and in-house/government, and has...
Significant biosimilar activities this week include: 18 Feb 23 | Takeda publishes results of Ph III trials of vedolizumab in preventing intestinal acute graft-versus-host disease...
In this patent infringement/validity dispute, Hanwha failed to establish that REC infringed its “old Act” Australian patent No 2008323025, and its dependant ACL claims were dismissed.
Significant biosimilar activities this week include: 09 Feb 23 | EU | EMA accepts MAA for Alvotech’s AVT04 (ustekinumab biosimilar) Alvotech and STADA announced that EMA has...
Significant biosimilar activities this week include: 24 Jan 23 | Saudi Food & Drug Authority approves Alvotech’s Simlandi® (biosimilar adalimumab) Alvotech and Bioventure...
Significant biosimilar activities this week include: 16 Jan 23 | Dong-A ST publishes the results of Ph III trials of DMB-3115 (biosimilar ustekinumab) Korea Biomedical Review...
Significant biosimilar activities this week include: 07 Jan 23 | Biocon receives complete response letter over insulin-r product. Biocon announced that it has received a complete...
TCT Group Pty Ltd v Polaris IP Pty Ltd [2022] FCA 1493Date:Court:Judge:14 December 2022Federal Court of AustraliaBurley JBackground Polaris IP Pty Ltd (Polaris IP) is the owner...
Significant biosimilar activities this week include: 15 Dec 22 | Zhejiang Doer Biologics and Merck clinical trials Zhejiang Doer Biologics announced a clinical trial...
Significant biosimilar activities this week include: 11 Dec 22 | New study reports glofitamab is effective in diffuse large B-cell lymphoma A new Roche study published in the New...
Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd [2022] APO 2 Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd [2022] APO 79Date:Venue:Delegates:14 January 2022, 2...
Significant biosimilar activities this week include: 03 Dec 22 | Alvotech announces changes to share listings and leadership team Alvotech announced that Nasdaq Iceland has...
Significant biosimilar activities this week include: 23 Nov 22 | EU | EMA approves Skyrizi® (risankizumab) for Crohn’s disease AbbVie announced that Skyrizi® (risankizumab) has...
Aristocrat Technologies Australia Pty Limited v Konami Australia Pty Limited (No 3) [2022] FCA 1373 Date:Court:Judge:18 November 2022Federal Court of AustraliaNicholas...
Significant biosimilar activities this week include: 18 Nov 22 | US | FDA approves Rezvoglar® (biosimilar insulin glargine) as interchangeable The FDA approved Eli Lilly’s...
Significant biosimilar activities this week include: 11 Nov 22 | EU | CHMP recommends Dupixent® (dupilimab) for prurigo nodularis The CHMP recommended the approval of Dupixent®...
Significant biosimilar activities this week include: 04 Nov 22 | New dupilumab study suggests serum dupilumab levels are not associated with treatment response or adverse effects...
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