Significant biosimilar activities this week include: 03 Dec 22 | Alvotech announces changes to share listings and...
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Naomi Pearce
BioBlast w/e 25 Nov 22: AbbVie’s risankizumab, FDA investigating Prolia® (denosumab) risk, Amneal’s filgrastim launch, Junshi Biosciences’ adalimumab, US biosimilars bill, Teva and Sandoz biosimilars ramp-up
Significant biosimilar activities this week include: 23 Nov 22 | EU | EMA approves Skyrizi® (risankizumab) for Crohn’s...
Account of profits/damages as complex as validity/infringement
Aristocrat Technologies Australia Pty Limited v Konami Australia Pty Limited (No 3) [2022] FCA 1373...
BioBlast w/e 18 Nov 22: Eli Lilly’s interchangeable insulin glargine, Organon trastuzumab and bevacizumab launches, Biocon Viatris’ biosimilar asset acquisition, Janssen guselkumab study, NICE Keytruda® recommendation, Stelis’ teriparatide
Significant biosimilar activities this week include: 18 Nov 22 | US | FDA approves Rezvoglar® (biosimilar insulin...
BioBlast w/e 11 Nov 22: Dupixent® recommended by CHMP, TME Pharma’s NOX-A12, World first denosumab biosimilar approved, Alvotech’s adalimumab IC data, Mylan’s IPR win against Regeneron aflibercept patents, MHRA biosimilars guidance, Amgen biosimilars data, Coherus’ ranibizumab
Significant biosimilar activities this week include: 11 Nov 22 | EU | CHMP recommends Dupixent® (dupilimab) for...
BioBlast w/e 04 Nov 22: dupilumab study, Accord cleans up at Global Generics and Biosimilars Awards, Amgen’s Supreme Court petition for certioriari regarding enablement granted, AU tocilizumab COVID shortage measures lifted, Bio-Thera’s secukinumab, Outlook’s ophthalmic bevacizumab, Rani Therapeutics’ oral ustekinumab
Significant biosimilar activities this week include: 04 Nov 22 | New dupilumab study suggests serum dupilumab levels...
BioBlast® w/e 28 Oct 22: Expanded indications in CA for Roche’s tocilizumab, AU PBAC outcomes, Alvotech financial results, Biogen seeks PI against Sandoz in natalizumab dispute, JSR/Similis Bio agreement, Regeneron/Mylan expedited aflibercept hearing, Genentech trade secrets sentencing
Significant biosimilar activities this week include: 28 Oct 22 | Health Canada approves additional COVID-19 indication...
BioBlast® w/e 21 Oct 22: Spectrum’s eflapegrastim, Eylea® paediatric exclusivity, Saskatchewan biosimilars switching program, AbbVie acquires DJS Antibodies, Lupin FDA observations, Alvotech and JAMP expand partnership, Alvotech/Fuji Pharma, Biocon’s ustekinumab, denosumab
Significant biosimilar activities this week include: 21 Oct 22 | US | Spectrum Pharmaceuticals launched Rolvedon™...
BioBlast® w/e 14 Oct 22: BioFactura’s ustekinumab, Prestige’s trastuzumab, Merck/Moderna personalised cancer vaccine combo, Regeneron’s aflibercept, Jacobio Pharma/Merck’s cetuximab, Janssen’s guselkumab/golimumab, Alvotech’s aflibercept
Significant biosimilar activities this week include: 14 Oct 22 | BioFactura’s biosimilar ustekinumab shows comparable...
Long-running mining systems dispute reaches the merits phase – Globaltech still infringing
Australian Mud Company Pty Ltd v Globaltech Corporation Pty Ltd & Ors (No 3) [2022] FCA 1189 ...
BioBlast® w/e 07 Oct 22: Samsung Bioepis’ adalimumab interchangeability, Celltrion’s adalimumab interchangeability, FDA biosimilars program, Amneal bevacizumab launch, Medicare Part B biosimilar payment increase
Significant biosimilar activities this week include: 08 Oct 22 | US | Samsung to pursue adalimumab interchangeability...
Establishing infringement of representative batches may be insufficient to establish liability
Pharmacia LLC v Juno Pharmaceuticals Pty Ltd [2022] FCA 92Pharmacia LLC v Juno Pharmaceuticals Pty Ltd (No 2) [2022]...
BioBlast® w/e 30 Sep 22: Biogen’s tocilizumab, Celltrion’s bevacizumab, Samsung Bioepis’ aflibercept and ranibizumab, Merck’s pembrolizumab, Intas’ ranibizumab, Pfizer/BioNTech/Moderna COVID vaccine patents, biosimilars executive order
Significant biosimilar activities this week include: 30 Sep 22 | EU | EMA accepts Biogen tocilizumab MAA Biogen...
Amgen’s five PCSK9 mAb patents upheld in opposition
Sanofi v Amgen Inc. [2022] APO 67Date:Venue:Delegate:26 September 2022Australian Patent OfficeSophina...
Jayne Jagot appointed to Australia’s High Court bench – a new era for diversity and for patent law
The Australian High Court will have an experienced intellectual property judge on its bench, with the appointment of...
BioBlast® w/e 23 Sep 22: Stada/Alvotech’s adalimumab launch, AZ/Merck olaparib PRC approval, AVEO’s ficlatuzumab US fast-tracked, Sandoz’s denosumab, interchangeability in the EU, Coherus’ US ranibizumab launch, Celltrion invalidates Rituxan® patent, Formycon’s pembrolizumab, Celltrion’s bevacizumab
Significant biosimilar activities this week include: 22 Sep 22 | CH | STADA launches Alvotech’s Hukyndra® (100mg/mL...