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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

Sandoz’s High Concentration Adalimumab Biosimilar PBS-Listed

Jan 1, 2025

On 1 January 2025, Sandoz’s high concentration Hyrimoz®, biosimilar to AbbVie’s Humira® (adalimumab) was listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in a 40 mg/0.4 mL injection, 2 x 0.4 mL pen formulation for the same indications as Humira®.

BMS’ Subcutaneous Nivolumab FDA-Approved

Dec 27, 2024

On 27 December 2024, BMS announced that the US FDA has granted approval for Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy) injection for subcutaneous use, a combination product of nivolumab co-formulated with recombinant human hyaluronidase (rHuPH20).  The approval covers most (but not all) previously approved adult, solid tumour Opdivo® indications as monotherapy, monotherapy maintenance following completion of Opdivo® plus Yervoy® (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. 

Biocon Receives EU Approval for Generic Liraglutide

Dec 24, 2024

On 24 December 2024, Biocon announced that the company and its European partner, Zentiva, have received Decentralised Procedure (DCP) approval for liraglutide in the European Union.  The approval is for the generic versions of Novo Nordisk’s Victoza®, to treat type-2 diabetes, and Saxenda®, used in the treatment of weight management.

GlycoNex Announces Licensing Deal for Denosumab Biosimilar

Dec 24, 2024

On 24 December 2024, GlycoNex announced that it has entered into a licensing agreement with an undisclosed partner for SPD8 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®. Under the agreement, the licensee will be responsible for developing SPD8, securing regulatory approval, and commercialising the biosimilar in an undisclosed market.

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