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.

See Naomi's full profile

BioBlast® w/e 19 August 2022: J&J Remicade decline, ALX evorpacept, FDA approves 100mg/mL Hadlima™, Formycon Ph III ustekinumab trials, Beovu® additional indication, EC approves Vegzelma™, Fresenius Kabi tocilizumab, Cipla pegfilgrastim, Merck/Orna Therapeutics collaboration

by Naomi Pearce, Emily Dwyer | Aug 22, 2022

Significant biosimilar activities this week include: 11 Aug 22 | ALX Oncology initiates Ph II trials of evorpacept in...

BioBlast® w/e 12 August 2022: Mylan Eylea® IPR, Daiichi Sankyo trastuzumab deruxtecan, Alvotech Icelandic listing move, Opthea funding for OPT-302, Merck Keytruda® clinical trials, Qila denosumab study

by Naomi Pearce, Emily Dwyer | Aug 15, 2022

Significant biosimilar activities this week include: 27 Jul 22 | CN | Ph III trial shows Qila’s denosumab biosimilar...

BioBlast® w/e 05 August 2022: Viatris’ etanercept; Celltrion’s seeks IC for Yuflyma®; Samsung Bioepis’ 3rd AU suit against Fresenius Kabi; AbbVie’s patent thicket; New Stelara® indication; Fresenius Kabi’s tocilizumab; Coherus’ ranibizumab US approved with IC; Regeneron sues Viatris (aflibercept); Coherus’ high concentration adalimumab

by Naomi Pearce, Alex May | Aug 9, 2022

Significant biosimilar activities this week include: 27 Jul 22 | AU | Viatris (Mylan) seeks PBS listing for etanercept...

PiPCast™ | PTE in Australia

by Naomi Pearce | Aug 5, 2022

Pearce IP’s Naomi Pearce speaks about the hot topic in Australian patent law: Patent Term Extension (PTE) in Australia

The Rise and Rise of CAR-T cell therapy and the Future of Patent Disputes in Australia

First published by WIPR on 22 June 2022

by Naomi Pearce, Kate Legge, Emily Dwyer | Aug 2, 2022

Chimeric Antigen Receptor (CAR)-T cell therapy is a pioneering technology that is successfully changing the way we...

Bringing home the bacon – or are you?

The future of labelling for plan based protein products

by Naomi Pearce, Emily Dwyer | Aug 2, 2022

Introduction Plant based protein products are already a well established destination in the supermarket aisle. ...

BioBlast® w/e 29 July 2022: FDA approves Sandoz’s natalizumab, TGA approves Henlius/Cipla trastuzumab, Prestige/Intas bevacizumab deal, Biocon biosimilars revenue up

by Naomi Pearce, Alex May | Aug 1, 2022

Significant biosimilar activities this week include: 25 Jul 22 | US | FDA accepts ABLA for natalizumab biosimilar...

Full Court dismisses Boehringer appeal on obviousness of veterinary injectable formulation

by Naomi Pearce, Kate Legge | Jul 26, 2022

The Full Court’s decision in Boehringer Ingelheim Animal Health USA Inc., v Intervet International B.V. [2022] FCAFC...

BioBlast® w/e 22 July 2022: Hikma/Celltrion adalimumab deal, Erasca/Lilly cetuximab clinical supply agreement, Celltrion’s tocilizumab clinical trial, Alvotech denosumab study, 100mg/mL Hyrimoz® adalimumab sBLA and Novartis/Sandoz update

by Naomi Pearce, Emily Dwyer | Jul 25, 2022

18 Jul 22 | MENA | Hikma and Celltrion enter into commercialisation agreement for YuflymaTM Hikma Pharmaceuticals...

BioBlast® w/e 15 July 2022: Alvotech board expansion, [vic-]trastuzumab duocarmazine BLA accepted, second Zylonta® + rituximab DLBCL trials, Polpharma natalizumab MAA and eight-year Perjeta® data

by Naomi Pearce, Emily Dwyer | Jul 18, 2022

11 Jul 22 | Overland ADCT commences trials of Zynlonta® in combination with rituximab in DLBCL Overland ADCT BioPharma...

WTO Members endorse latest COVID IP waiver draft

by Kate Legge, Naomi Pearce | Jul 18, 2022

The key terms of an updated draft covid IP waiver have been released by the WTO. The draft includes terms intended to...

BioBlast® w/e 8 July 2022: featuring Xbrane’s ranibizumab BLA, Viatris’ insulin glargine, Alvotech’s aflibercept study and AU’s July PBAC meeting

by Naomi Pearce, Emily Dwyer | Jul 11, 2022

04 Jul 22 | US | Xbrane Biopharma provides update on ranibizumab biosimilar Xbrane Biopharma confirmed that it will...

BioBlast® w/e 01 July 22: Samsung seeks to revoke Fresenius’ AU adalimumab patent, Daiichi Sankyo’s trastuzumab deruxtecan sNDA submitted in Japan, PDS0101 Fast-tracked in US, Henlius HLX53 IND accepted

by Naomi Pearce, Emily Dwyer | Jul 4, 2022

24 Jun 22 | AU | Samsung Bioepis commences AU revocation action against Fresenius Kabi adalimumab patent Samsung...

BioBlast® w/e 24 Jun 22: Alvotech dual NASDAQ listing, Samsung Bioepis/Samil ranibizumab, Formycon Q1/22 results, Daiichi Sankyo trastuzumab deruxtecan, Midas Pharma’s ranibizumab, Celltrion’s bevacizumab, Merck’s pembrolizumab, AVEO/Eli Lilly agreement, Innovent’s sintilimab

by Naomi Pearce, Emily Dwyer | Jun 27, 2022

20 Jun 22 | CN | NMPA approves Innovent’s TYVYT® (sintilimab injection) Innovent Biologics and Eli Lilly announced...

BioBlast® w/e 17 Jun 22: featuring Alvotech’s NASDAQ listing, Samsung Bioepis’ eculizumab, Organon/Henlius’ global biosimilars deal, Sandoz’s citrate-free adalimumab and Innovent’s bevacizumab

by Naomi Pearce, Emily Dwyer | Jun 20, 2022

11 Jun 22 | Samsung Bioepis presents Ph III eculizumab data Samsung Bioepis presented data from its Ph III trials of...

BioBlast® w/e 10 June 2022: featuring Alvotech/Stada’s adalimumab, Amgen’s rituximab, Fresenius’ tocilizumab IPR, dostarlimab study and Civica’s insulin

by Naomi Pearce, Emily Dwyer | Jun 15, 2022

02 Jun 22 | Civica selects Profil as clinical trial partner for affordable insulin initiative Civica announced that is...