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On 25 August 2025, Bio-Thera and STADA announced that they have extended their strategic biosimilars partnership to cover tocilizumab.  Under the agreement, Bio-Thera will maintain responsibility for development, manufacture and supply of the biosimilar (to Roche’s RoActemr...

On 25 August 2025, Ono Pharma and Bristol-Myers Squibb announced that they received supplemental approval in Japan for Opdivo® (nivolumab) and Yervoy® (ipilimumab) in combination therapy for the treatment of unresectable advanced or recurrent microsatellite instability-high...

At its July 2025 meeting, Australia’s Pharmaceutical Benefits and Advisory Committee (PBAC) rejected MSD’s proposal for a multi-indication (broad) listing for Keytruda® (pembrolizumab) in advanced or metastatic cancers.  MSD had proposed that Keytruda® be PBS listed for all...

On 22 August2025, the outcomes of Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) July 2025 meeting were published, including recommendations for the listing of three biosimilars on the Pharmaceutical Benefits Scheme (PBS).

Sandoz’s aflibercept biosimil...

On 22 August 2025, BIOCAD announced that the Russian Ministry of Health has approved Daratumia®, biosimilar to Johnson & Johnson’s Darzalex® (daratumumab), as the first daratumumab biosimilar approved in the country.  This is the first reported regulatory approval for a...

On 21 August 2025, New Zealand’s Medsafe approved Pfizer’s Ixifi®, biosimilar to Janssen’s Remicade® (infliximab), in 100mg IV formulation for all reference indications.

Ixifi® will be the second infliximab biosimilar available in New Zealand, following Celltrion’s R...

On 21 August 2025, BioDlink (previously known as TOT BIOPHARM) announced that its Bevacizumab Injection, biosimilar to Roche/Genentech’s Avastin®, has received marketing approval from Indonesia’s National Agency of Drug and Food Control (BPOM).

This news comes ...

On 21 August 2025, Alvotech and Advanz Pharma announced that Mynzepli® (AVT06), biosimilar to Regeneron/Bayer’s 2mg Eylea® (aflibercept) has been approved by the European Commission in pre-filled syringe and vial presentations.  Mynzepli® received a positive CHMP opinion in...

On 20 August 2025, Regeneron announced that the FDA has extended its target action dates to Q4/2025 for two Eylea HD® (aflibercept, 8mg) regulatory submissions:

a supplemental BLA (accepted by the FDA for Priority Review in April 2025) seeking approval for the trea...