Gilead Sciences Pty Ltd v Minister for Health and Ageing [2026] FCA 232
Date of decision:
12 March 2026
Body:
Federal Court of Australia<...
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By Naomi Pearce, Paul Johns, Helen Macpherson | Aug 24, 2026
Gilead Sciences Pty Ltd v Minister for Health and Ageing [2026] FCA 232
Date of decision:
12 March 2026
Body:
Federal Court of Australia<...
By Bioblast Editor | Aug 21, 2026
On 21 August 2026, Celltrion announced that it has launched Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), in an intravenous (IV) formulation in Japan.
Celltrion’s IV formulation of Steqeyma® was approved in Japan in April 2026, with the subcutaneous form...
By Bioblast Editor | Aug 21, 2026
On 21 August 2026, Alvotech and Lotus Pharmaceutical announced that they have entered into a licensing and commercialisation agreement for Alvotech’s AVT34, biosimilar to AstraZeneca’s Imfinzi® (durvalumab), and AVT87, biosimilar to Roche/Genentech’s Hemli...
By Bioblast Editor | Aug 21, 2026
On 21 August 2026, the outcomes of the July 2026 meeting of the Australian Pharmaceutical Benefits Advisory Committee (PBAC) were published, with the following biosimilars recommended for PBS listing:
Biocon/Generic Health’s Yesintek® (ustekinumab), biosimilar to J...
By Pearce IP | Aug 20, 2026
Two of Pearce IP’s leaders have been recommended by the Lexology Index: Intellectual Property 2026 which honours a small number of leading IP lawyers across 88 countries.
CEO ...
By Bioblast Editor | Aug 19, 2026
On 19 August 2026, Ono announced that it has received additional approval for Opdivo® (nivolumab) Intravenous Infusion from the Taiwan Food and Drug Administration (TFDA), for the neoadjuvant treatment of adult patients with resectable Non-Small Cell Lung Cancer (NSCLC) and...
By Naomi Pearce, Chantal Savage, Maliha Hoque | Aug 18, 2026
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 14 August 2026 are set out belo...
By Bioblast Editor | Aug 18, 2026
On 18 August 2026, Biocon announced that it has received supplemental FDA approval for Yesintek®, biosimilar to Janssen’s Stelara® (ustekinumab), in a single-dose prefilled autoinjector format (45 mg/0.5 ml and 90 mg/ml).
Biocon first launched Yesintek® in the US in ...
By Bioblast Editor | Aug 18, 2026
On 18 August 2026, Avalon Pharmaceutical and Bio-Thera Solutions announced that they have entered into an exclusive licensing agreement for the commercialisation of Bio-Thera’s BAT2406, biosimilar to Sanofi/Regeneron’s Dupixent® (dupilumab), in MENA.
Under the agreem...
By Bioblast Editor | Aug 18, 2026
On 18 August 2026, Korea Biomedical Review reported that Sam Chun Dang (SCD) signed a settlement agreement with Regeneron and Bayer to resolve all patent disputes in Europe, Korea and Japan involving SCD411, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2 mg. ...
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