Read our latest updates & insights

On 24 February 2026, Biocon announced that its liraglutide, gSaxenda®, biosimilar to Novo Nordisk’s Victoza® (liraglutide), has been approved by the FDA.  gSaxenda® is a drug-device combination (6 mg/mL single-use pre-filled pen) approved for the treatment of chronic weight...

On 24 February 2026, Sana Pharma announced that Pembrava™, biosimilar to MSD’s Keytruda® (pembrolizumab), has been registered by the Jordan Food and Drug Administration for cancer treatment.  Sana Pharma claims that Pembrava™ is the first biosimilar for cancer treatment in ...

On 24 February 2026, Ono Pharmaceutical announced that the Korean Ministry of Food and Drug Safety has granted additional approval of Opdivo® (nivolumab) intravenous infusion in combination with Yervoy® (ipilimumab), for the treatment of adults with unresectable or metastat...

On 24 February 2026, Regeneron and Sanofi announced that Dupixent® (dupilumab) has been approved by the FDA for treating adults and children aged 6 years and older with fungal rhinosinusitis (AFRS) who have a history of sino-nasal surgery.  Dupixent® is the first and only t...

On 24 February 2026, Business Korea reported that Fresenius Kabi has settled its aflibercept US patent dispute with Regeneron.  The announcement was made in a shareholder notice issued by Sam Chun Dang (SCD), which has licensed its aflibercept biosimilar to Fresenius for US...

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...