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Home / News / Pearce IP Blog

PEARCE IP BLOG

Read our latest updates & insights

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

Pearce IP’s Leaders Honoured in WIPR Diversity’s Top 100 2024

Pearce IP’s Leaders Honoured in WIPR Diversity’s Top 100 2024

by | May 7, 2024

Our Head of Talent has been honoured by WIPR as a Change Driver and is one of only 5 business services professionals ranked around the world, and is the only Australian honoured. Pearce IP’s Executive, Head of Patent Prosecution has been honoured by WIPR as a Diversity Champion, the only Australian recognised in this category.

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Recent BioBlast® Updates

Henlius Secures FDA IND Clearance for SC Daratumumab Biosimilar

Feb 16, 2026

On 16 February 2026, Shanghai Henlius Biotech announced it has obtained Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its subcutaneous daratumumab biosimilar, HLX15-SC.  This will allow Henlius to undertake a phase I clinical study of HLX15-SC, biosimilar to J&J’s Darzalex Faspro® (daratumumab and hyaluronidase-fihj), for the first-line treatment of multiple myeloma.

STADA/Bio-Thera’s Biosimilar Golimumab Approved in Europe

Feb 13, 2026

On 13 February 2026, STADA and Bio-Thera Solutions announced that the European Commission has granted marketing authorisation for Gotenfia®, biosimilar to Janssen’s Simponi® (golimumab).  According to the announcement, plans are underway to launch Gotenfia® in Europe “in the coming weeks and months”.

Amgen’s Biosimilar Ustekinumab Back on PBAC Agenda

Feb 12, 2026

On 12 February 2026, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) updated its March 2026 agenda (first published in November 2025) to include consideration for reimbursement of Amgen’s Wezlana®, biosimilar to Janssen’s Stelara® (ustekinumab).

Arrotex & Pfizer Partner on Etanercept in Australia

Feb 12, 2026

On 12 February 2026, Pharmacy Daily announced that Arrotex Pharmaceuticals and Pfizer Australia have entered into a commercial partnership for Enbrel® (etanercept) in Australia.  Under the agreement, Arrotex will be responsible for representing Pfizer’s Enbrel® across Australian pharmacies, hospital, and prescriber channels.

EMA Approves Streamlining Celltrion’s Ph 3 Biosimilar Secukinumab Trial

Feb 11, 2026

On 11 February 2026, Celltrion announced that it received approval from the European Medicines Agency (EMA) to reduce patient numbers enrolled in its global Phase 3 clinical trial for CT-P55, biosimilar to Novartis’ Cosentyx® (secukinumab).  Celltrion expects this approval to shorten the overall clinical timeline and to reduce development expenses for CT-P55.

Formycon & Lotus Partner on Biosimilar Pembrolizumab in Asia-Pacific

Feb 11, 2026

On 11 February 2026, Formycon and Taiwan-based Lotus Pharmaceutical announced they have concluded an exclusive licence agreement in relation to the commercialisation of Formycon’s FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab), in major parts of the Asia-Pacific region.

Zydus Optimistic About Filing First Biosimilar Pembrolizumab BLA in US

Feb 10, 2026

During its Q3 FY26 Earnings Call on 10 February 2026, Zydus Lifesciences indicated that it is hoping to be the first to file a Biologics Licence Application in the US for a pembrolizumab biosimilar and may potentially be first to launch in the US, subject to regulatory approvals. 

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