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On 10 June 2026, GlycoNex announced that its denosumab biosimilar, SPD8, met the primary endpoint in a Phase 3 osteoporosis study conducted in Japan, demonstrating therapeutic equivalence to Amgen’s Prolia® (denosumab).  SPD8 was co-developed by GlycoNex with Mitsubishi Gas...

On 9 June 2026, Shanghai Henlius Biotech announced that China’s National Medical Products Administration has approved a new indication of Hansizhuang® (serplulimab, marketed as Hetronifly® in EU), in combination with Oxaliplatin and S-1.  The new indication is the neoadjuva...

On 9 June 2026, Mabpharm announced that China’s National Medical Products Administration (NMPA) has approved CMAB807 (Puboli®) (60 mg pre-filled syringe), biosimilar to Amgen’s Prolia®, for the treatment of osteoporosis in postmenopausal women at increased fracture ri...

On 8 June 2026, Alvotech announced that its Biologics License Application (BLA) for AVT16, biosimilar to Takeda’s Entyvio® (vedolizumab), has been accepted for review by the FDA.  AVT16 is presented in a lyophilised vial for intravenous administration.  This is the first re...

On 5 June 2026, Shanghai Henlius Biotech announced that the first US patient has been dosed in its international Phase 1 clinical trial of HLX17, biosimilar to MSD’s Keytruda® (pembrolizumab).  The study had previously completed first patient dosing in China.

The Pha...

On 4 June 2026, Kashiv BioSciences announced that Health Canada has accepted for review the market authorisation application (MAA) for ADL-018, biosimilar to Genentech/Novartis’ Xolair® (omalizumab).

Under an exclusive licensing agreement with Kashiv entered in Octob...

On 4 June 2026, GxP News reported that Belarusian company, BioImmunity LLC, has obtained registration in Belarus of its biosimilar to Novartis’ Ilaris® (canakinumab) and is seeking approval in Russia.  If registered, this will become the second canakinumab biosimilar approv...

On 4 June 2026, Alvotech announced that it has resubmitted to the FDA its Biologics License Applications for AVT05 (golimumab), biosimilar to Janssen’s Simponi® and Simponi Aria®, and AVT06 (aflibercept), biosimilar to Regeneron/Bayer’s Eylea®, 2mg.  Alvotech expects the FD...