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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

Amgen Initiates Ph 3 Study for Pembrolizumab Biosimilar

May 2, 2024

On 2 May 2024, Amgen revealed that it initiated a Phase 3 study to compare the efficacy, pharmacokinetics, safety and immunogenicity of its pembrolizumab biosimilar, ABP 234, with Keytruda® in patients with advanced or metastatic non-squamous non-small cell lung...

J&J Indication Expansion for Tremfya® (guselkumab)

May 1, 2024

On 01 May 2024, Johnson & Johnson announced that it submitted applications to the European Medicines Agency (EMA) to expand the Marketing Authorisation for Tremfya® (guselkumab) to include the treatment of adult patients with moderately to severely active...

Phase 3 Supports MSD’s Keytruda® Combo for Gastric Cancer

May 1, 2024

On 1 May 2024, MSD announced that the final analysis of the Phase 3 KEYNOTE-811 clinical trial (sponsored by MSD) demonstrated that Keytruda® (pembrolizumab), in combination with trastuzumab and chemotherapy, provided gastric cancer patients with a statistically...

Australia’s PBAC Recommends Three Biosimilars for Reimbursement

Apr 29, 2024

On 26 April 2024, Australia’s Pharmaceutical Benefits Assessment Committee (PBAC) published the outcomes of the applications for reimbursement considered at its March 2024 meeting. The following biosimilars have been recommended for listing on the Pharmaceutical...

First US Biosimilar Approval for Accord BioPharma’s Trastuzumab

Apr 29, 2024

On 29 April 2024, Intas subsidiary Accord BioPharma announced that the FDA has approved Hercessi™, biosimilar to Roche’s Herceptin® (trastuzumab), for the treatment of HER2-overexpressing breast and gastric / gastroesophageal junction adenocarcinoma.  This is the...

Europe’s CHMP Positive Opinion on Biogen’s Tocilizumab Biosimilar

Apr 25, 2024

On 25 April 2024, Biogen announced that its Tofidence™ (tocilizumab), biosimilar to Roche's RoActemra®, received a positive opinion from EMA’s Committee for Medicinal Products for Human Use (CHMP).  The recommendation relates to the IV formulation of tocilizumab for...

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