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On 12 February 2025, Qyuns Therapeutics Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has accepted the marketing authorisation application and supplemental application for QX001S, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), for...

On 12 February 2025, Pfizer announced that the US FDA has approved Adcetris® (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL).  Specific indications include trea...

On 12 February 2025, UCB announced that two-year data from the BE HEARD trials for Bimzelx® (bimekizumab) demonstrated sustained disease control in patients with moderate to severe hidradenitis suppurativa (HS).

The data revealed that after two years of treatment wit...

On 12 February 2025, New Zealand’s Pharmac announced that, from 1 March 2025, it will extend funding of Celltrion’s Vegzelma®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), for patients with recurrent respiratory papillomatosis, ocular conditions, liver cancer and...

On 11 February 2025, the Australian Therapeutic Goods Administration (TGA) approved Alovtech and Cipla’s Uteknix®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in two formulations:

90 mg/1 mL solution for injection pre-filled syringe (422260); and
...

On 11 February 2025, MSD announced that Health Canada has approved Keytruda® (pembrolizumab) for the treatment of adults with resectable Stage II, IIIA, or IIIB non-small cell lung carcinoma (NSCLC), in combination with chemotherapy as neoadjuvant treatment, and then contin...

On 11 February 2025, Regeneron announced that the US FDA has accepted for review its resubmitted Biologics Licence Application (BLA) for linvoseltamab.  Linvoseltamab, a BCMAxCD3 bispecific antibody, is indicated for the treatment of adult patients with relapsed/refractory ...

On 10 February 2025, Bio-Thera Solutions announced that it has entered an exclusive US commercialisation and licence agreement with Intas Pharmaceuticals for BAT2506 (golimumab), biosimilar to J&J’s Simponi® and Simponi Aria®.

Under the agreement, Intas Pharmaceu...

On 10 February 2025, Pfizer and Astellas Pharma announced positive results from their Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39).  The trial evaluated the efficacy and safety of Padcev® (enfortumab vedotin-ejfv) in combination with MSD’s Keytruda® (pembrolizu...