Put simply, recent developments in Australian law and practice concerning Patent Term Extensions (PTEs) and preliminary injunctions (PIs) will shake up the pharmaceutical market.
Pearce IP BioBlast® for the week ending 20 February 2026
By Naomi Pearce, Chantal Savage, Maliha Hoque | Feb 24, 2026
Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending 20 February 2026 are set out bel...
MASTERCLASS | Register | A Seismic Shift in Pharma Patent Law & Practice in Australia
By Pearce IP | Feb 23, 2026
Do Recent Developments in PTEs & PIs Create New Strategic Opportunities to Disrupt the Pharma Market?
The market entry dynamics for generic and biosimilar launches in Australia have dramatically shifted. Two elements are responsible for this shift:
➡️ PTE: ...
Lupin/Sandoz’s Biosimilar Ranibizumab Approved in EU
By Bioblast Editor | Feb 23, 2026
On 23 February 2026, Sandoz announced that the European Commission has approved Ranluspec®, biosimilar to Genentech’s Lucentis® (ranibizumab). Sandoz is currently planning to launch Ranluspec® in the EU in the second half of 2026.
The EU marketing approval follows a...
Dr Reddy’s Biosimilar Abatacept BLA Accepted for Review by FDA
By Bioblast Editor | Feb 20, 2026
On 20 February 2026, Dr Reddy’s Laboratories announced that its Biologics Licence Application (BLA) for DRL_AB, biosimilar to BMS’ Orencia® (abatacept), has been accepted for review by the FDA. Dr Reddy’s expects regulatory approval in the US at the end of 2026 for the IV ...
Outlook Therapeutics Inks Exclusive Deal with Mediconsult for Ophthalmic Bevacizumab in Switzerland
By Bioblast Editor | Feb 19, 2026
On 19 February 2026, Outlook Therapeutics announced that it has entered into an exclusive commercial distribution agreement with Mediconsult for Lytenava™ (ONS-5010, bevacizumab-vikg/bevacizumab gamma) in Switzerland.
Under the agreement, Mediconsult has exclusive ri...
Zydus Launches Biosimilar Aflibercept in India
By Bioblast Editor | Feb 19, 2026
On 19 February 2026, Zydus announced the Indian launch of Anyra™, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2 mg. Anyra™ is the first aflibercept 2mg biosimilar developed in India and is launched under licence from Regeneron and Bayer.
Anyra™ is approved ...
New Indication Alert: Sandoz’s Biosimilar Aflibercept FDA Approved for Additional Retinal Indications
By Bioblast Editor | Feb 18, 2026
On 18 February 2026, Sandoz announced that the FDA has approved an indication extension for Enzeevu®, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2mg, to include macular oedema following retinal vein occlusion, diabetic retinopathy and diabetic macular oedema. Enz...
Out With The In-Crowd – Gene Therapy For A Previously Excluded, Antibody-Positive Patient Group Ruled Non-Inventive
By Paul Johns, Julie Ballance, Helen Macpherson | Feb 18, 2026
uniQure IP B.V. [2025] APO 14 (19 May 2025)
Date of decision:
19 May 2025
Body:
Australian Patent Office
Adjudicator:
M. Ume...
Lack Of Clarity Sends Patent Claims Down The Drain - All Valve & Anor V Comino & Anor
By Paul Johns, Helen Macpherson | Feb 18, 2026
Watson Webb Pty Ltd v Comino [2025] FCA 871
Date of decision:
30 July 2025
Body:
Federal Court of Australia
Adjudicator:
Jus...
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