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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

R-Pharm Provides Updates on Pertuzumab and Cetuximab Biosimilars

Dec 22, 2025

On 22 December 2025, R-Pharm announced that it has presented its progress on two biosimilar products at the 29th Russian Oncology Congress: Persinthia®, biosimilar to Roche’s Perjeta® (pertuzumab), for the treatment of HER2-positive breast cancer; and Arcetux®, biosimilar to Eli Lilly/Merck KgGa’s Erbitux® (cetuximab), for treatment of head and neck tumours.

FDA approves Ph I Trial of Shanghai Henlius’ Biosimilar Nivolumab

Dec 19, 2025

On 19 December 2025, Shanghai Henlius Biotech announced to investors that the US FDA has approved an investigational new drug application (IND) for the phase 1 clinical trial of HLX18, biosimilar to BMS’ Opdivo® (nivolumab), for the treatment of multiple solid tumours.  

Positive CHMP Opinion for Celltrion’s Biosimilar Ustekinumab Autoinjector

Dec 18, 2025

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® (ustekinumab).

Reimbursement Recommendation in Canada for Opdivo® plus Yervoy® for MSI-H/dMMR Metastatic Colorectal Cancer

Dec 17, 2025

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 metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) who meet certain criteria.

Mabwell Launches Biosimilar Denosumab Outside China

Dec 16, 2025

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. 

Celltrion Launches Biosimilar Aflibercept in EU & UK

Dec 16, 2025

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.  

New Indication Alert: FDA Approves Perjeta® Plus Enhertu® for HER2-Postive Breast Cancer

Dec 15, 2025

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 the first new 1st-line treatment approved in a decade for this indication.

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