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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...

On 17 February 2026, Accord BioPharma announced it has received FDA approval for Filkri™, biosimilar to Amgen’s Neupogen® (filgrastim), for the same indications as the reference medicine.

There are multiple filgrastim biosimilars that have been approved by the FDA si...

On 16 February 2026, Shanghai Henlius Biotech announced it has obtained Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) for its subcutaneous daratumumab biosimilar, HLX15-SC.  This will allow Henlius to undertake a phase I clinical st...

On 13 February 2026, STADA and Bio-Thera Solutions announced that the European Commission has granted marketing authorisation for Gotenfia®, biosimilar to Janssen’s Simponi® (golimumab).  According to the announcement, plans are underway to launch Gotenfia® in Europe “in th...

On 12 February 2026, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) updated its March 2026 agenda (first published in November 2025) to include consideration for reimbursement of Amgen’s Wezlana®, biosimilar to Janssen’s Stelara® (ustekinumab).

In Apri...

On 12 February 2026, Pharmacy Daily announced that Arrotex Pharmaceuticals and Pfizer Australia have entered into a commercial partnership for Enbrel® (etanercept) in Australia.  Under the agreement, Arrotex will be responsible for representing Pfizer’s Enbrel® across Austr...

On 12 February 2026, Zhitong Finance reported that Shanghai Henlius Biotech has obtained approval from China’s National Medical Products Administration (NMPA) for a Phase 1 trial of its subcutaneous daratumumab biosimilar, HLX15-SC.

This follows Henlius’ completion o...