ALL BLOGS BY

Naomi Pearce

Naomi is listed in IAM Patent 1000 as one of Australia's leading patent litigators. Underpinning Naomi’s legal work is a deep understanding of the pharma/biopharma industries, resulting from first hand experience and knowledge as VP of IP in-house at global pharma giants, and Partner of a top-tier international law firm.

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BioBlast w/e 24 Mar 23: IPRs re Regeneron aflibercept patents | NMPA approves Xgeva® (denosumab) | FDA approves Hyrimoz® (adalimumab) | and more…

by Naomi Pearce, Sian Hope | Mar 27, 2023

Significant biosimilar activities this week include: 22 March 2023 | US | PTAB institutes Celltrion and Samsung IPRs...

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

by Naomi Pearce, Sian Hope | Mar 20, 2023

Significant biosimilar activities this week include: 01 March 2023 | CA | Study finds nonmedical switching policy did...

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 …

by Naomi Pearce, Sian Hope | Mar 13, 2023

Significant biosimilar activities this week include: 09 March 2023 | EU | Sandoz signs MOU for USD$400M biologics...

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

by Naomi Pearce, Sian Hope | Mar 6, 2023

Significant biosimilar activities this week include: 28 February 2023 | IN | Enzene Biosciences begins supply of...

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

by Naomi Pearce, Sian Hope, Emily Dwyer | Feb 27, 2023

Significant biosimilar activities this week include: 22 February 2023 | EU | AbbVie sued by Dutch group over Humira®...

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

by Naomi Pearce, Emily Dwyer | Feb 20, 2023

Significant biosimilar activities this week include: 18 Feb 23 | Takeda publishes results of Ph III trials of...

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

by Naomi Pearce, Emily Dwyer | Feb 13, 2023

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

by Naomi Pearce, Emily Dwyer | Jan 30, 2023

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

by Naomi Pearce, Emily Dwyer | Jan 16, 2023

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

by Naomi Pearce, Emily Dwyer | Jan 9, 2023

Significant biosimilar activities this week include: 07 Jan 23 | Biocon receives complete response letter over...

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

by Naomi Pearce, Emily Dwyer | Dec 19, 2022

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

by Naomi Pearce, Emily Dwyer | Dec 12, 2022

Significant biosimilar activities this week include: 11 Dec 22 | New study reports glofitamab is effective in diffuse...

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

by Naomi Pearce, Emily Dwyer | Dec 5, 2022

Significant biosimilar activities this week include: 03 Dec 22 | Alvotech announces changes to share listings and...

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

by Naomi Pearce, Emily Dwyer | Nov 29, 2022

Significant biosimilar activities this week include: 23 Nov 22 | EU | EMA approves Skyrizi® (risankizumab) for Crohn’s...

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

by Naomi Pearce, Emily Dwyer | Nov 21, 2022

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

by Naomi Pearce, Emily Dwyer | Nov 14, 2022

Significant biosimilar activities this week include: 11 Nov 22 | EU | CHMP recommends Dupixent® (dupilimab) for...