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At its December 2024 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended granting marketing authorisation for CSL’s Andembry® (garadacimab) for prevention of recurrent attacks of hereditary angioedema (HAE).  Galderma’s...

On 12 December 2024, Gedeon Richter and Hikma Pharmaceuticals announced that FDA has accepted for review Hikma’s BLA for RGB-14 (denosumab), biosimilar to Amgen’s Prolia® and Xgeva®.

Pursuant to an exclusive licence agreement entered in December 2021, Hikma is respon...

At its December 2024 meeting, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for six biosimilars.

Four of these are Celltrion biosimilars: Eydenzelt®/CT-P42 (aflibercept), biosimilar to Regeneron/Bayer’s...

On 11 December 2024, AstraZeneca and MSD announced positive results for Lynparza® (olaparib) in the treatment of breast cancer, as demonstrated in the OlympiA Phase III trial presented at the San Antonio Breast Cancer Symposium 2024.  

Lynparza® reduced the risk of d...

On 9 December 2024, GSK announced that the National Medical Products Administration (NMPA) of China has accepted for review a new drug application (NDA) for Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) as a treatment for relapse...

On 9 December 2024, Formycon and MS Pharma announced that they have entered into a licence and supply agreement for commercialisation of Formycon’s FYB202, biosimilar to Janssen’s Stelara® (ustekinumab), in the Middle East and North Africa (MENA).

Under the agreement...

On 9 December 2024, MSD announced that its Phase 3 KEYLYNK-0001 trial for Keytruda® (pembrolizumab) plus chemotherapy, followed by maintenance with AstraZeneca’s Lynparza® (olaparib) (with or without bevacizumab) met its primary endpoint of progression-free survival in firs...

On 9 December 2024, Celltrion announced that Omlyclo® (CT-P39), biosimilar to Genentech/Novartis’ Xolair® (omalizumab) was approved by Health Canada.  The approval is for all indications of Xolair®, including allergic asthma, idiopathic urticaria and chronic rhinosinusitis ...

On 9 December 2024, GSK announced that the US FDA has accepted for review data to support a new indication for the use of Nucala® (mepolizumab) as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. ...