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On 17 July 2024, Boan Biotech announced that China’s Centre for Drug Evaluation of the National Medical Products Administration (NMPA) has accepted its BLA for BA9101, biosimilar to Regeneron’s Eylea® (aflibercept).  The BA9101 application is for all Eylea® indications, nam...

On 17 July 2024, Junshi Biosciences announced that China’s National Medical Products Administration has accepted for review its supplemental new drug application (sNDA) for Tuoyi® (toripalimab) combined with bevacizumab for first-line treatment of unresectable or metastatic...

On 17 July 2024, Celltrion reported that its Remsima SC (infliximab subcutaneous injection), biobetter to Remsima® (IV product), a biosimilar to Janssen’s Remicade® (infliximab), has recorded European market share of over 20% for the first time since its 2020 EU launch.  Th...

On 17 July 2024, ASLAN Pharmaceuticals announced that it has filed for voluntary liquidation of its Singaporean sole operating subsidiary and will itself also apply for liquidation.  ASLAN reports that the appointed liquidator of the Singapore subsidiary will seek “potentia...

On 16 July 2024, the Munich Central Division of the UPC issued judgment in revocation actions brought by Sanofi and Regeneron, declaring Amgen’s evolocumab patent EP3666797 invalid in all 17 UPC contracting States, based on lack of inventive step.  This is the first patent ...

On 16 July 2024, Sandoz announced the Canadian launch of Wyost® (denosumab), biosimilar to Amgen’s Xgeva®.  Wyost® is available as a 120 mg subcutaneous injection for use every four weeks.

Wyost® was the first denosumab biosimilar approved in Canada in March 2024 for...

On 9 July 2024, Celltrion announced that it has received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for its omalizumab (Omlyclo®, CT-P39) as biosimilar to Genentech’s and Novartis’ Xolair® for allergic asthma and chronic i...

On 11 and 12 July 2024, respectively, Eisai and Biogen announced that Leqembi™ (lecanemab) has been approved in Hong Kong and Israel for treating Alzheimer’s disease in patients with mild cognitive impairment or at the mild dementia stage of the disease.

Leqemb...