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On 18 December 2025, Celltrion announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of an autoinjector (pre-filled pen) form of Steqeyma® and Qoyvolma®, biosimilars to J&J/Janssen’s Stelara® (ustek...

On 18 December 2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) November 2025 meeting were published, including recommendations for the listing of three Celltrion biosimilars on the Pharmaceutical Benefits Scheme (PBS):

Eydezenlt®...

Sally Paterson and Paul Johns discuss and compare various intellectual property laws in New Zealand that provide protection for three-dimensional designs and shapes.

On 17 December 2025, Bristol Myers Squibb announced that Canada’s Drug Agency (CDA-AMC) has issued a positive reimbursement recommendation for Opdivo® (nivolumab) in combination with Yervoy® (ipilimumab) for the first-line treatment of adult patients with unresectable or me...

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...