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On 13 February 2025, CSL announced that the European Commission has approved Andembry® (garadacimab) to prevent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older.

This is the third approval for the anti-FXIIa mAb, followi...

On 13 February 2025, the US FDA approved Samsung Bioepis’ Ospomyv™ and Xbryk™ (denosumab-dssb, SB16), biosimilars to Amgen’s Prolia® and Xgeva® respectively.  The biosimilars are approved for the same indications as the reference medicines.

Ospomyv™ and Xbryk™ are th...

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 ...