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May 30, 2024
On 30 May 2024, the Korea IT Times reported that Celltrion announced it received domestic approval from South Korea's Ministry of Food and Drug Safety for EydenzeltTM (CT-P42), biosimilar to Regeneron's Eylea® (aflibercept). Eydenzelt was approved for the same...
May 30, 2024
As previously reported, on 17 May 2024, a temporary 14 day restraining order was granted preventing Biocon from launching its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), in the US without a licence from Regeneron. The purpose of the temporary order was...
May 30, 2024
On 30 May 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of marketing authorisation for FGK’s Avzivi®, biosimilar to Genentech’s Avastin® (bevacizumab). The...
May 29, 2024
On 29 May 2024, MSD announced that the FDA accepted for priority review its sBLA for Keytruda® (pembrolizumab) plus chemotherapy as first line treatment for unresectable advanced or metastatic malignant pleural mesothelioma. The target action date for the FDA...
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...
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