Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 20 June 2025 are set out below:...
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Stay informed about important legal and industry news with our blogs and weekly BioBlast® updates.
By Naomi Pearce, Chantal Savage, Nathan Kan | Jun 24, 2025
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 20 June 2025 are set out below:...
By Bioblast Editor | Jun 24, 2025
On 24 June 2025, Biocon Biologics announced it has partnered with the National Cancer Society of Malaysia (NCSM), a non-for-profit organisation, to launch a Patient Assistance Program advocating for the accessibility and affordability of biosimilars. Biocon intends to supp...
By Bioblast Editor | Jun 24, 2025
On 24 June 2025, Ono Pharmaceutical and BMS announced that they have received a supplemental approval for expanded use of Ono’s Opdivo® (nivolumab) and BMS’ Yervoy® (ipilimumab) in combination for the treatment of unresectable hepatocellular carcinoma (HCC). The approval c...
By Bioblast Editor | Jun 23, 2025
On 23 June 2025, Alvotech and Advanz Pharma announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for AVT06, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg).
AVT06 is indicated fo...
By Bioblast Editor | Jun 23, 2025
On 4 June 2025, Regeneron and Bayer filed proceedings against Sandoz in the Australian Federal Court alleging infringement of Regeneron’s AU2012205599 relating to methods of treatment for angiogenic eye disorders. Regeneron is seeking both an interlocutory injunction and f...
By Bioblast Editor | Jun 23, 2025
On 23 June 2025, the FDA approved Samsung Bioepis’ sBLA for an unbranded version of Hadlima® (adalimumab-bwwd), biosimilar to AbbVie’s Humira®.
Samsung Bioepis is not the first to offer an unbranded US adalimumab biosimilar, with the FDA approving Celltrion’s sBLA fo...
By Bioblast Editor | Jun 20, 2025
Several biosimilars are positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) from 1 July 2025, namely: Celltrion’s Steqeyma® (ustekinumab, biosimilar to Janssen’s Stelara®), Viatris’ Nepexto® (etanercept, biosimilar to Pfizer’s Enbrel®), Sandoz’s Tyruk...
By Bioblast Editor | Jun 20, 2025
On 20 June 2025, Australia’s Pharmaceutical Benefits Scheme (PBS) published its outcomes from the May 2025 PBAC intracycle meeting, with BMS’ Opdivo® (nivolumab) and Yervoy® (ipilimumab) recommended for reimbursement for stage III melanoma and Novartis’ Xolair® (omalizumab)...
By Bioblast Editor | Jun 20, 2025
On 20 June 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) published the outcome of its June meeting, with positive opinions for aflibercept biosimilars of STADA, Polpharma and Advanz Pharma, and Bio-Thera’s biosimilar ustekinumab...
By Pearce IP | Jun 20, 2025
Pearce IP one of 3 Privately Owned Firms Ranked
Today Pearce IP was named by Australasian Lawyer and NZ Lawyer as one of ANZ’s Top Specialist Firms 2025.
Pearce IP is ...
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