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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.

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Recent BioBlast® Updates

Henlius and Abbott Partner on Biosimilar Commercialisation in Emerging Markets

Jan 13, 2025

On 13 January 2025, Shanghai Henlius announced that it has entered a product licence and supply agreement with Abbott under which Abbott is granted exclusive or semi-exclusive rights to the commercialisation of four biosimilars and one innovative biologic.  The commercialisation rights cover 69 emerging markets in Asia, Latin America, Middle East and Africa.

Amgen’s Ocrelizumab Biosimilar in Phase 3 Trials

Jan 13, 2025

At the JP Morgan Annual Healthcare conference on 13 January 2025, Amgen revealed that it currently has an ocrelizumab biosimilar (ABP 692) in Phase 3 trials. The Phase 3 study (NCT06700343), which begins enrolment this month in the US, is aimed at demonstrating

Astellas’ Vyloy® Combo Approved in Canada and China for Gastric and GEJ Cancer

Jan 9, 2025

On 9 January 2025, Astellas Pharma announced that Health Canada has approved Vyloy® (zolbetuximab for injection) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumours are claudin (CLDN) 18.2 positive.  Canada’s Drug Agency (CDA-AMC) recently issued a draft recommendation to reimburse Vyloy™ with conditions. 

J&J’s Nipocalimab Granted FDA Priority Review for Generalised Myasthenia Gravis

Jan 9, 2025

On 9 January 2025, Johnson & Johnson (J&J) announced that the US FDA has granted its nipocalimab Priority Review designation for the treatment of antibody positive (anti-AChR, anti-MuSK, anti-LRP4) patients with generalised myasthenia gravis (gMG), as supported by findings from the Phase 3 Vivacity-MG3 study.  J&J submitted a Biologics Licence Application (BLA) to the FDA seeking approval for this indication in August 2024.

Biocon’s Biosimilar Ustekinumab Approved in Japan

Jan 7, 2025

On 7 January 2025, Biocon announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved its subcutaneous ustekinumab (Bmab 1200), biosimilar to J&J/Janssen’s Stelara®.  Biocon’s biosimilar ustekinumab will be commercialised and marketed in Japan by its exclusive commercial partner, Yoshindo Inc.

Approval Alert: AbbVie’s Epkinly® (Epcoritamab) Provisionally Approved in Australia

Jan 6, 2025

On 6 January 2025, the Therapeutic Goods Administration (TGA) provisionally approved AbbVie’s Epkinly® (epcoritamab) in 4mg/0.8mL concentrate solution and 48mg/0.8mL solution for injection vial, indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

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