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May 29, 2024
On 29 May 2024, Merck (MSD) announced the acquisition of privately owned opthalmology focussed biotech EyeBio for US$3 billion, including an upfront payment of US$1.3 billion and $US1.7 billion in milestone payments. The acquisition has been unanimously approved by...
May 28, 2024
On 28 May 2024, Amgen filed a complaint against Celltrion in the United States District Court for the District of New Jersey alleging infringement of 29 patents relating to denosumab. The allegations relate to Celltrion’s abbreviated Biologics Licence Application...
May 28, 2024
On 28 May 2024, Bio-Thera and STADA announced they have entered an exclusive commercialisation agreement in relation to BAT2506, biosimilar to Janssen’s Simponi® (golimumab). Under the agreement, Bio-Thera has responsibility for developing and manufacturing...
May 28, 2024
On 28 May 2024, Amgen’s Bkemv® (eculizumab-aeeb) was approved by the FDA as the first interchangeable biosimilar to Alexion’s Soliris® (eculizumab). Bkemv® is approved for the same indications as Soliris® (atypical hemolytic uremic syndrome (aHUS) and paroxysmal...
May 28, 2024
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...
May 27, 2024
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...
May 27, 2024
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 treatment to...
May 27, 2024
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...
May 27, 2024
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...
May 24, 2024
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...
May 23, 2024
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...
May 22, 2024
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,...
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