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On 5 March 2025, Generics Bulletin reported that Amgen has launched Bkemv® (eculizumab-aeeb) in the US as the first available interchangeable biosimilar to Alexion’s Soliris®.

Bkemv® was approved by the FDA in May 2024 for the same indications as Soliris® (atypical h...

On 5 March 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Celltrion from launching its biosimilar to Regeneron’s Eylea® (aflibercept) in the US without a licence from Regeneron.

In doing so, the Appeals C...

On 4 March 2025, BeiGene announced that the US FDA has approved its Tevimbra® (tislelizumab), in combination with platinum-containing chemotherapy, for the first-line treatment of adults with unresectable or metastatic oesophageal squamous cell carcinoma (ESCC) whose tumour...

On 4 March 2025, AbbVie announced that Skyrizi® (risankizumab) is now available in Canada for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, loss of response, or were intolerant to conventional...

On 4 March 2025, NeurologyLive reported that the US FDA has approved an expanded indication of Alexion/AstraZeneca’s Soliris® (eculizumab) to include both adult and paediatric patients 6 years of age or older with generalised myasthenia gravis (gMG) who are antiacetylcholin...

On 3 March 2025, Fresenius announced the US launch of Otulfi®/FYB202 (ustekinumab-aauz), biosimilar to J&J/Janssen’s Stelara®.

FYB202/Otulfi® was developed by Formycon and was approved in the US and Europe in September 2024.  It is being commercialised in the US,...

On 3 March 2025, Eisai and Biogen announced that Australia’s Therapeutic Goods Administration (TGA) has confirmed its initial decision to decline the approval of Leqembi® (lecanemab) for the treatment of early Alzheimer’s Disease (AD).  Eisai is “extremely disappointed and ...

On 3 March 2025, Amneal Pharmaceuticals and mAbxience announced that the FDA has accepted for review their aBLA for two new denosumab biosimilars referencing Amgen’s Prolia® and Xgeva®.   The FDA has assigned a target action date in Q4 2025.

The biosimilars are being...