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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...

Major Australian news outlets such as the ABC reported this week that, on the advice of the TGA, the Australian Federal Government will ban pharmacy-compounded copies of Novo Nordisk’s Ozempic® and Eli Lilly’s Mounjaro®, which are widely used off label for weight loss, foll...

On 21 May 2024, Alvotech provided its financial results for Q1 2024, reporting total revenues of US$37 million compared to US$16M for the same quarter in 2023.

Alvotech reports its highlights for Q1/24 as:

the FDA approval of SelarsdiTM (AVT04, ustekinumab-a...

On 21 May 2024, Alvotech and Dr Reddy’s announced that that they have entered into a licence and supply agreement for the commercialisation of AVT03 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva® in the US, EU and UK.

Under the agreement, Alvotech will develop...

As previously reported, in the context of the ongoing US aflibercept litigation, Regeneron previously filed motions for preliminary injunctions against each of Celltrion, Formycon and Samsung Bioepis.  On 21 May 2024, Regeneron withdrew its preliminary injunction motions in...