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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

Approval Alert: Biogen’s Tocilizumab Biosimilar EU Approved

Jun 24, 2024

On 24 June 2024, Biogen announced its IV tocilizumab, TOFIDENCE™, biosimilar to Roche’s ROACTEMRA®, has been approved by EC.  Tofidence is authorised by the EC for treating moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis,...

Teva Announces US Launch of Authorised Generic Liraglutide

Jun 24, 2024

On 24 June 2024, Teva Pharmaceuticals announced the US launch of its authorised generic liraglutide injection (1.8 mg) for type 2 diabetes.  Originator Novo Nordisk supplies liraglutide as Victoza®, and Teva’s authorised generic Victoza is the first generic GLP-1...

Phase 3 Results for Qilu Pharmaceutical’s Pertuzumab Biosimilar

Jun 21, 2024

Results of phase 3 pertuzumab studies comparing Qilu’s QL1209 with Roche’s Perjeta® with trastuzumab and docetaxel were published in the British Journal of Cancer on 21 June 2024.   The studies demonstrated that QL1209 is equivalent to Perjeta® in safety and efficacy...

Amgen’s Ustekinumab Biosimilar Approved in EU

Jun 20, 2024

On 20 June 2024, Amgen’s WezenlaTM, biosimilar to Janssen’s Stelara® (ustekinumab) received marketing authorisation in Europe.  This followed a positive CHMP recommendation in April 2024. Wezlana™ was approved in the US in October 2023, was launched in Canada in March...

FDA Review and Phase III Alert: Biocon’s Ustekinumab Biosimilar

Jun 19, 2024

On 16 May 2024, Biocon reported that the US’s FDA had accepted Biocon’s BLA for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway. Biocon had earlier signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson that allows...

Alvotech & Advanz Pharma Partner on EU Aflibercept Biosimilars

Jun 18, 2024

On 18 June 2024, Alvotech announced that it has entered into an agreement with Advanz Pharma in relation to the commercialisation in Europe of Alvotech’s AVTO6 and AVT29, biosimilars to Regeneron’s Eylea® (aflibercept) in low (2mg) and high (8mg) doses, respectively. ...

Samsung Biologics Inks $223m deal with Baxter Healthcare

Jun 18, 2024

Samsung Biologics has renegotiated its manufacturing agreement with Baxter Healthcare, increasing Baxter's payments to Samsung to over US$223 million through the end of 2034, up from an initial US$15m. The specifics of the products Samsung will manufacture for Baxter...

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