Significant biosimilar activities this fortnight include: 13 April 2023 | US | Alvotech CRL provided to FDA regarding high concentration buffer free biosimilar adalimumab 12...
BioBlast f/e 14 Apr 23
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Webinar | Pharmaceutical Patent Term Extensions The Good, The Bad and the Ugly
Webinar | Pharmaceutical Patent Term Extensions The Good, The Bad and the Ugly
BioBlast w/e 31 Mar 23: Humira® AU price reduction | EMA recommends Samsung’s EPYSQLI™ eculizumab | US Supreme Court hears Amgen v Sanofi | Eli Lilly $1B mAb manufacture investment in Ireland | Daiichi Enhertu® JP approval | Coya and Dr. Reddy’s ww development agreement … and more!
Significant biosimilar activities this week include: 01 April 2023 | AU | Humira® 24.39% PBS price drop 30 March 2023 | EU | EMA CHMP gives nod to Samsung Bioepis’ Epysqli™...
High Court finds no wrinkles in PROTOX and INHIBOX brands
The High Court recently issued its decision in the case of Self Care IP Holdings Pty Ltd & Anor v Allergan Australia Pty Ltd & Anor [2023] HCA 8. The court surprised many...
BioBlast w/e 24 Mar 23: IPRs re Regeneron aflibercept patents | NMPA approves Xgeva® (denosumab) | FDA approves Hyrimoz® (adalimumab) | and more…
Significant biosimilar activities this week include: 22 March 2023 | US | PTAB institutes Celltrion and Samsung IPRs re Regeneron’s key aflibercept patents 21 March 2023 | CN |...
BioBlast w/e 17 Mar 23: Alvotech ustekinumab | Samsung Bioepis’ ustekinumab | Humira® US Medicare Rebates | Apotex aflibercept IPR | J&J US$25M Remicade® settlement | Lantus® price cut | Samsung Biologics US$1.5B plant … and more
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...
Nailed It – the Full Federal Court upholds purposive construction of fuel cell claims
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...
BioBlast w/e 10 Mar 23: MiGenTra African developed Humira biosim | USD$400M Sandoz biosim facility | Celltrion fourth aflibercept IPR | Celltrion Remsima SC® | Coherus Udenyca® US approval | Genentech sues Biogen & Millennium for Cabilly royalties | Jannsen Amgen Stelara® dispute …
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...
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 Humira® (adalimumab) biosimilar in India Biospectrum...
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® pricing The Financial Times has reported that the Dutch...
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.
Pearce IP welcomes Donna Meredith (Patent & Trade Mark Attorney)
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...
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 vedolizumab in preventing intestinal acute graft-versus-host disease...
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 (ustekinumab biosimilar) Alvotech and STADA announced that EMA has...
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 Simlandi® (biosimilar adalimumab) Alvotech and Bioventure...
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 DMB-3115 (biosimilar ustekinumab) Korea Biomedical Review...
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 insulin-r product. Biocon announced that it has received a complete...
Threats of infringement unjustified after swimming pool door hinge patents revoked
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...
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 Zhejiang Doer Biologics announced a clinical trial...
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 large B-cell lymphoma A new Roche study published in the New...
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 Ltd [2022] APO 79Date:Venue:Delegates:14 January 2022, 2...
BioBlast w/e 02 Dec 22: Janssen sues Amgen over ustekinumab, Capstone’s insulin, Erasca trials, Alvotech leadership changes, MHRA Dupixent® guidance, Merck sues JHU on Keytruda patents, Hikma and Celltrion ustekinumab deal
Significant biosimilar activities this week include: 03 Dec 22 | Alvotech announces changes to share listings and leadership team Alvotech announced that Nasdaq Iceland has...
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