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On 28 May 2024, Outlook Therapeutics announced it received EU marketing authorisation for LYTENAVATM (ONS-5010, bevacizumab-gamma) for the treatment of wet AMD.  Bevacizumab has been used off label for ophthalmic conditions for many years and this approval marks the first a...

On 27 May 2024, Fresenius Kabi announced that its BLA for denosumab has been accepted for review by the US FDA as biosimilar to Amgen’s Prolia®.  The biosimilar is to be indicated for osteoporosis in men and women, including glucocorticoid-induced osteoporosis, and bone los...

On 27 May 2024,  Eisai and Biogen announced that South Korea’s Ministry of Food and Drug Safety approved Leqembi® (lecanemab) for treating adults with mild cognitive impairment or mild Alzheimer’s disease.   

Leqembi® is reportedly the first approved trea...

On 27 May 2024, Samsung Bioepis presented follow-up results from a Phase 3 study on SB16, biosimilar to Amgen’s Prolia® (denosumab).  According to Samsung Bioepis, the study demonstrated that switching postmenopausal osteoporosis patients from Prolia® to SB16 produced compa...

On 27 May 2024, Boan Biotech announced that its Boluojia® (BA11021, denosumab injection, 120mg) received marketing approval from China’s National Medical Products Administration (NMPA) as biosimilar to Amgen’s Xgeva®.  Boluojia® is indicated for the treatment of giant cell ...

On 24 May 2024, Shanghai Henlius and Organon announced that the European Medicines Agency (EMA) validated Henlius’ and Organon’s applications for denosumab as biosimilars to Amgen’s Prolia® and Xgeva®.  The applications are based on Phase 3 trials confirming HLX14 is equiva...

On 23 May 2024, Celltrion announced that the European Commission has approved its omalizumab (Omlyclo®, CT-P39) as biosimilar to Genentech’s and Novartis’ Xolair® for allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP)....

Biocon Limited announced on 24 May 2024 that it signed an exclusive licensing and supply agreement with Korea’s Handok Inc for the commercialisation in South Korea of its synthetic liraglutide, biosimilar to Novo Nordisk’s Victoza®.

Under the terms of the agreement, ...

On 22 May 2024, the European Commission approved the first denosumab biosimilars in Sandoz’s Wyost® and Jubbonti®.  The biosimilars were approved with a full indication set mirroring the approved indications of Amgen’s Xgeva® and Prolia® respectively, and have the same dosa...