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On 16 December 2025, the Australian Therapeutic Goods Administration (TGA) approved Celltrion’s Steqeyma®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in two pre-filled pen (PFP) formulations:

90 mg/1 mL solution for injection pre-filled pen (500305); a...

On 16 December 2025, China-based Mabwell announced that it has completed its first commercial shipment of its denosumab biosimilars outside China, although the destination(s) of the shipment is not disclosed in the press release.

Mabwell’s biosimilars to Amgen’s Prol...

On 16 December 2025, Celltrion announced that it has launched Eydenzelt®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), in major European countries, including Germany, Portugal and the UK.

Eydenzelt® received European approval in February 2025 for the treatme...

Pearce IP’s CEO, Naomi Pearce, speaks with our Heads of Litigation for Australia and New Zealand about the practice of “skinny labelling” of generic drugs.  They discuss whether a “skinny label” approach will assist in avoiding patent infringement of method of treatme...

On 15 December 2025, AstraZeneca announced that the FDA has approved the combination of Enhertu® (trastuzumab deruxtecan) with Roche’s Perjeta® (pertuzumab) for the 1st-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.  This is th...

On 13 December 2025, Biocon Biologics announced that it has reached a settlement and licence agreement with Regeneron and Bayer for Yesafili®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) in Europe and ROW, enabling Biocon to launch Yesafili® in the UK in January 20...