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Amgen announced the results of a Ph III study evaluating the efficacy and safety of ABP959 (proposed eculizumab biosimilar) compared with Soliris® in adult patients with paroxysmal nocturnal haemoglobinuria.  Amgen reported that the study met its primary endpoints and that ...

Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety has approved an expanded indication for Novartis’ Beovu® (brolucizumab).  The approved indications now include diabetic macular oedema.

Significant biosimilar activities this week include:

11 Aug 22 | ALX Oncology initiates Ph II trials of evorpacept in combination with cetuximab and pembrolizumab

ALX Oncology announced the initiation of Ph II trials of evorpacept (CD47 blocker) in combination...

AU’s TGA approved Cipla’s FILPEGLA® (biosimilar pegfilgrastim) for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

Fresenius Kabi announced that the EMA has accepted its MAA for MSB11456 (biosimilar tocilizumab).  The application includes clinical data for both subcutaneous and IV administrations.

Celltrion announced that the EC approved Vegzelma™ (biosimilar bevacizumab) for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical canc...

Samsung Bioepis and Organon announced that the FDA has approved the citrate-free, high-concentration (100mg/mL) formulation of Hadlima™ (biosimilar adalimumab).  The Hadlima 50mg/ml formulation was FDA approved in July 2019.  Hadlima is expected to be launched on or after 1...

Formycon has reported that its ustekinumab biosimilar candidate FYB202 showed comparable efficacy and safety to Janssen’s Stelara in a Ph III clinical trial in plaque psoriasis patients.  Formycon’s extended pharmacokinetics Ph I study has commenced.  This follows Formycon’...

MSD and Orna Therapeutics announced that they have entered into a collaboration agreement to discover, develop and commercialise multiple RNA programs, including vaccines and therapeutics in the areas of infectious diseases and oncology.