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Stay informed about important legal and industry news with our blogs and weekly BioBlast® updates.

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 | Aug 9, 2022

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

Medicinal Cannabis in Australia | Part 6: What’s in a name – Trade mark protection for MC strains

by Pearce IP | Aug 8, 2022

In the field of medicinal cannabis, plant varietal or cultivar names that are protected by a registered right such as a PBR (plant breeder right) are often mirrored in commercial...

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 | Aug 2, 2022

Chimeric Antigen Receptor (CAR)-T cell therapy is a pioneering technology that is successfully changing the way we think about the treatment of cancer, in particular blood...

Bringing home the bacon – or are you?

The future of labelling for plan based protein products

by Naomi Pearce | Aug 2, 2022

Introduction Plant based protein products are already a well established destination in the supermarket aisle. Australia is reportedly the third fastest growing market for such...

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 | Aug 1, 2022

Significant biosimilar activities this week include: 25 Jul 22 | US | FDA accepts ABLA for natalizumab biosimilar Sandoz announced that the FDA has accepted its ABLA for a...

Pearce IP and its CEO feature in shortlist for Women in Business Law Awards APAC 2022

by Pearce IP | Jul 27, 2022

We are proud to announce that Pearce IP and its CEO have been shortlisted for three awards at the APAC 2022 Women in Business Law Awards, with the winners to be announced on...

Pearce recognised as one of the Australasian Lawyer’s Most Influential Lawyers for 2022

by Pearce IP | Jul 27, 2022

With great pleasure, we announce that our CEO and Executive Lawyer, Patent Attorney and Trade Mark Attorney Naomi Pearce has been named as one of the Australasian Lawyer’s Most...

Full Court dismisses Boehringer appeal on obviousness of veterinary injectable formulation

by Naomi Pearce | Jul 26, 2022

The Full Court’s decision in Boehringer Ingelheim Animal Health USA Inc., v Intervet International B.V. [2022] FCAFC 88 is a useful analysis of the application of the “Cripps...

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 | Jul 25, 2022

18 Jul 22 | MENA | Hikma and Celltrion enter into commercialisation agreement for YuflymaTM Hikma Pharmaceuticals announced that it has entered into a commercialisation agreement...

“Sketchy” prior art renders Globaltech device patent not obvious

by Naomi Pearce | Jul 19, 2022

Globaltech Corporation Pty Ltd v Reflex Instruments Asia Pacific Pty Ltd [2022] FCA 797Date:Court:Judge:12 July 2022Federal Court of AustraliaJagot JBackground Globaltech...

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 | Jul 18, 2022

11 Jul 22 | Overland ADCT commences trials of Zynlonta® in combination with rituximab in DLBCL Overland ADCT BioPharma announced the dosing of the first patient in China in its...

WTO Members endorse latest COVID IP waiver draft

by 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 alleviate concerns of developed countries. However it will...

Pearce IP celebrates milestone birthday and firm and individual rankings in IAM Patent 1000 2022

by Pearce IP | Jul 13, 2022

This week Pearce IP celebrated its 5th birthday, and received glowing reviews and rankings for the firm, and for three of its individual patent professionals by IAM Patent 1000....

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 | Jul 11, 2022

04 Jul 22 | US | Xbrane Biopharma provides update on ranibizumab biosimilar Xbrane Biopharma confirmed that it will resubmit a BLA for its biosimilar to Lucentis® (ranibizumab)...

Pearce IP Prosecution Team Listed in MIP IP Stars

by Pearce IP | Jul 6, 2022

Pearce IP is proud to announce that our prosecution team has also been ranked among the best in Australia by Managing IP. This is in addition to the individual rankings of...

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 | Jul 4, 2022

24 Jun 22 | AU | Samsung Bioepis commences AU revocation action against Fresenius Kabi adalimumab patent Samsung Bioepis filed a suit against Fresenius Kabi in the AU Federal...

Pearce IP named as Finalist for Intellectual Property Team of the Year – Australian Law Awards 2022

by Pearce IP | Jun 29, 2022

We are proud to announce that the Pearce IP team of patent and trademark lawyers and attorneys has been selected as a finalist for the Lawyers Weekly Intellectual Property Team...

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 | Jun 27, 2022

20 Jun 22 | CN | NMPA approves Innovent’s TYVYT® (sintilimab injection) Innovent Biologics and Eli Lilly announced that the CDE of China’s NMPA has approved the sNDA for TYVYT®...

Computer–implemented method of reducing waste of unused medicines rejected by the Patent Office

by Naomi Pearce | Jun 24, 2022

Carefusion 303, Inc [2022] APO 40Date:Venue:Delegate:17 June 2022Australian Patent OfficeG PowellBackground Patent Application 2014268829 was filed by Carefusion 303, Inc on 16...

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 | Jun 20, 2022

11 Jun 22 | Samsung Bioepis presents Ph III eculizumab data Samsung Bioepis presented data from its Ph III trials of SB12 (eculizumab biosimilar) in paroxysmal nocturnal...

Pearce named as finalist for the 2022 Lawyers Weekly Partner of the Year Awards (IP)

by Pearce IP | Jun 16, 2022

Congratulations to CEO and Executive Naomi Pearce for being named as a finalist for the Lawyers Weekly Partners of the Year Awards 2022 in the category of Intellectual Property....

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 | Jun 15, 2022

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

BioBlast® w/e 03 June 2022: featuring Outlook’s bevacizumab, Lannett’s insulin glargine, Henlius’ biosims, Novartis’ brolucizumab, Roche’s faricimab, Biogen/Samsung Byooviz™ & GBMA Biosimilars Awareness Week

by Naomi Pearce | Jun 6, 2022

24 May 22 | BR | Shanghai Henlius Biotech signs license agreement for rituximab and trastuzumab biosims Shanghai Henlius Biotech announced that it has entered into a...

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Recent BioBlast® Updates

India’s CDSCO Publishes Draft Revised Biosimilar Guidelines for Stakeholder Comment

May 6, 2025

On 6 May 2025, India’s Central Drugs Standard Control Organization (CDSCO) published draft revised guidelines on biosimilars, which update marketing authorisation requirements for biosimilars in line…

Biocon Secures Multiple US Market Access Agreements for Biosimilar Ustekinumab

May 5, 2025

On 5 May 2025, Biocon Biologics announced that it has entered multiple market access agreements in the US for Yesintek®, biosimilar to J&J’s Stelara® (ustekinumab). This includes the addition of…

FDA Approves Interchangeability of Alvotech/Teva’s Selarsdi® with J&J’s Stelara® (Ustekinumab)

May 5, 2025

On 5 May 2025, Alvotech and Teva announced that the US FDA has approved Selarsdi® (ustekinumab-aekn) as interchangeable with J&J’s Stelara® (ustekinumab) in all presentations…

Court Rules Samsung Bioepis Can Sell Private Label Ustekinumab Brands in US

May 1, 2025

On 1 May 2025, Business Korea reported that, on 28 April 2025, Samsung Bioepis defeated Johnson & Johnson (J&J) and Janssen Biotech’s application for a preliminary injunction preventing US sales of…

CHMP Recommends Label Update for Roche’s Pertuzumab/Trastuzumab Combo; Roche Unconcerned About Pertuzumab Biosimilar Threat

Apr 30, 2025

On 30 April 2025, Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending an update to the European Union (EU) label for Phesgo®…

Sandoz to “Minimise” Phase 3 Biosimilar Pembrolizumab Trial due to Regulatory Streamlining

Apr 30, 2025

On 30 April 2025, when announcing its Q1/2025 financial results, Sandoz indicated that it will be “minimising” the Phase 3 trial of its biosimilar to MSD’s Keytruda® (pembrolizumab) in patients with…

UK’s MHRA Approves BMS’ SC Opdivo® (Nivolumab)

Apr 30, 2025

On 30 April 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved a subcutaneous (SC) formulation of BMS’ Opdivo® (nivolumab). The SC formulation of nivolumab…

Sandoz and Henlius Enter USD 300M Deal to Commercialise Biosimilar Ipilimumab

Apr 29, 2025

On 29 April 2025, Sandoz and Shanghai Henlius Biotech announced that they have entered into a global collaboration agreement to commercialise a biosimilar of BMS’ Yervoy® (ipilimumab)…

CuraTeQ’s Biosimilar Trastuzumab Receives Positive CHMP Opinion in EU

Apr 25, 2025

At its April meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Aurobindo Pharma’s subsidiary CuraTeQ’s Dazublys®…

Positive CHMP Opinions for 8 Denosumab Biosimilars

Apr 25, 2025

On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing approval for eight denosumab biosimilars…

Samsung Bioepis Publishes Quarterly US Biosimilar Market Report; Steep WAC Discounts for Newly Launched Ustekinumab Biosimilars

Apr 24, 2025

On 24 April 2025, Samsung Bioepis published its ninth quarterly US Biosimilar Market Report, which has been released every quarter since April 2023. The report details average sales price (ASP) and…

MSD Sued for US Patent Infringement Over SC Pembrolizumab

Apr 24, 2025

On 24 April 2024, Halozyme Therapeutics announced that it has sued MSD for patent infringement in the US District Court for the District of New Jersey…

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