Significant biosimilar activities this week include: 09 March 2023 | EU | Sandoz signs MOU for USD$400M biologics...
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Naomi Pearce
Carpark overstay detection system patent saga continues with award of additional damages for flagrant infringement
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.
BioBlast w/e 03 March 23: BioBlast w/e 03 March 23: Enzene adalimumab launch | Biocon CRL | Celltrion & GeneMedicine trastuzumab deal | Alvotech 2022 results | Celltrion & Samsung Bioepis seek to join Mylan aflibercept IPR | Pfizer/Samsung Biologics manufacturing agreement | Janssen ustekinemab proceedings against Amgen | Celltrion founder returns | Biogen CA ranibizumab biosimilar approved
Significant biosimilar activities this week include: 28 February 2023 | IN | Enzene Biosciences begins supply of...
Increasing Access to Biosimilar Act introduced to US House of Representatives
The ‘Increasing Access to Biosimilar Act of 2023’ (HR 1352) was introduced into the US House of Representatives. The...
BioBlast w/e 24 Feb 23: Abbvie in hot water over Humira® pricing, Celltrion’s Yuflyma® delays explained, Merck/Moderna mRNA vaccine/ Keytruda treatment, French Court overturns Novartis/Roche €444M cartel fine, Amgen’s Amjevita® savings, Genetech new biologics facility, Regeneron new aflibercept product, Amgen’s Bekemv® eculizumab
Significant biosimilar activities this week include: 22 February 2023 | EU | AbbVie sued by Dutch group over Humira®...
Federal Court confirms the ‘protective and remedial’ operation of extension of time provisions
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.
BioBlast w/e 17 Feb 2023: Takeda’s vedolizumab trials, Organon’s financial results, Biora’s PGN-OB1 trials, Fresenius Kabi’s pegfilgrastim, Henlius’ trastuzumab, Coherus/Junshi Biosciences’ toripalimab trials, Similis Bio/Novel 351K biosimilars partnership, Biocon bevacizumab FDA Complete Response Letter
Significant biosimilar activities this week include: 18 Feb 23 | Takeda publishes results of Ph III trials of...
Nailed It – Full Federal Court upholds purposive construction of fuel cell claims
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.
BioBlast f/e 10 Feb 2023: Alvotech’s ustekinumab & omalizumab, new US indication for Eylea®, Sandoz’s US denosumab biosimilar, Amgen US Amjevita® (adalimumab) launch, Sandoz’s citrate-free adalimumab, Celltrion’s Vegzelma™ (bevacizumab), Merck Keytruda® trial, Celltrion aflibercept IPR, Sanofi’s Dupixent® (dupilumab) approval
Significant biosimilar activities this week include: 09 Feb 23 | EU | EMA accepts MAA for Alvotech’s AVT04...
BioBlast® w/e 27 Jan 23: Alvotech Simlandi® (biosimilar adalimumab) approval, Alvotech completes private placement round, PTAB institutes Mylan aflibercept challenges, Dr Reddy’s rituximab, BeiGene’s denosumab, MHRA grants Ximluci® (biosimilar ranibizumab) marketing authorisation, NMPA approves BAT1806 (biosimilar tocilizumab), Genentech and Tanvex settlement, Luye Pharma denosumab
Significant biosimilar activities this week include: 24 Jan 23 | Saudi Food & Drug Authority approves Alvotech’s...
BioBlast® w/e 13 Jan 23: Alvotech’s golimumab, Alvotech and Fuji commercialisation partnership, Dong-A ST’s ustekinumab, Coherus and Klinge’s deal for US aflibercept, Boan Biotech and CP Qingdao denosumab deal, Rani and Celltrion’s oral ustekinumab biosimilar
Significant biosimilar activities this week include: 16 Jan 23 | Dong-A ST publishes the results of Ph III trials of...
BioBlast® w/e 06 January 2023: Biocon insulin, Alvotech ustekinumab, Celltrion Vegzelma™ (bevacizumab), Lannett’s biosimilar insulin products, Alteogen and Celltrion agreement, Samsung Bioepis adalimumab interchangeability, Amgen’s adalimumab, Ontario biosimilar switching program, Hikma and Celltrion bevacizumab agreement, Samsung Bioepis Hadlima® approval, Keytruda® trials, Celltrion’s subcutaneous infliximab, Alvotech adalimumab, Dr Reddy’s tocilizumab, ustekinumab biosimilar
Significant biosimilar activities this week include: 07 Jan 23 | Biocon receives complete response letter over...
Threats of infringement unjustified after swimming pool door hinge patents revoked
TCT Group Pty Ltd v Polaris IP Pty Ltd [2022] FCA 1189Date:Court:Judge:14 December 2022Federal Court of...
BioBlast w/e 16 Dec 22: Doer Biologics and Merck collaboration, expanded Dupixent® indications, Fresenius US citrate-free Idacio® (adalimumab) approval, Merck and Moderna cancer vaccine trial results, Amgen acquires Horizon, Alvotech lists on Nasdaq Iceland Main Market, Regeneron seeks expedited motion in aflibercept dispute
Significant biosimilar activities this week include: 15 Dec 22 | Zhejiang Doer Biologics and Merck clinical trials...
BioBlast w/e 09 Dec 22: Roche’s glofitamab, Paras Biopharma’s new biosimilars division, Biogen’s biosimilar tocilizumab, Alvotech/Stada’s EU Hukyndra® roll out, Biocon closes Viatris biosimilars acquisition
Significant biosimilar activities this week include: 11 Dec 22 | New study reports glofitamab is effective in diffuse...
Fall from Grace: Patent Office allows extension of time for claim to grace period but patent still found invalid
Generic Partners Pty Ltd v Neurim Pharmaceuticals Ltd [2022] APO 2 Generic Partners Pty Ltd v Neurim Pharmaceuticals...