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On 5 March 2026, Pearce IP hosted a Masterclass on changes that mean market entry dynamics for generic and biosimilar launches in Australia have dramatically shifted.  Two elements are responsible for this shift: PTEs and PIs.

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...

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 ...

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...

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 ...

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...

On 17 February 2026, MSD announced that Health Canada has approved Keytruda SC™ (pembrolizumab), a subcutaneous (SC) formulation of pembrolizumab injection for multiple cancer indications.

The Canadian approval follows European approval of Keytruda SC™ in November 20...