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On 31 May 2024, Regeneron and Sanofi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Dupixent® (dupilumab) as an add-on maintenance treatment for uncontrolled chronic obstructive pulmo...

On 30 May 2024, Samsung Bioepis announced that it will present a post-hoc analysis of the Phase 3 study results for its EpysqliTM (SB12), biosimilar to Alexion’s Soliris® (eculizumab), at the 29th European Hematology Association Congress to be held in Spain from 13-16 June ...

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 ...

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 to ma...

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 app...

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 decision is 2...

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 EyeBio’...

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 (aBLA) su...

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 BAT250...

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 nocturnal...