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Korea Biomedical Review reported that the 24 week results from Celltrion’s Ph III trials of CT-P42 (aflibercept) demonstrate equivalence and similarity to Regeneron’s Eylea®.  CT-P42 met secondary endpoints of efficacy, safety, and immunogenicity when compared with Regenero...

AstraZeneca announced that the CHMP has recommended marketing authorisation for its Ultomiris® (ravulizumab) to treat patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 antibody positive.  If authorised, Ultomiris® would be the first and o...

The PBS Catch-up Statutory Price Reductions have reduced the cost of AbbVie’s Humira® products by 24.39% to $618.90, with adalimumab biosimilars (Arrow Pharma’s Hadlima®, Apotex’ Amgevita®, Sandoz’ Hyrimoz® and Fresenius Kabi’s Idacio®) reduced by 6.91%.  Interestingly, thi...

Eli Lilly has launched its insulin glargine Rezvoglar®, biosimilar to Sanofi’s Lantus®, on the US market.  It will be offered at a 78% discount to Lantus®.  Rezvoglar® is the second insulin glargine biosimilar (following Viatris/Mylan’s Semglee®) to be supplied to the US.  ...

Mabwell announced that it received Chinese marketing approval for Mailishu® (denosumab), biosimilar to Amgen’s Xgeva®/Prolia®, from the National Medical Products Administration (NMPA) for the treatment of osteoporosis in postmenopausal women at high risk of fracture.  It is...

EMA recommended granting marketing authorisation for Samsung Bioepis’ Epysqli™ (eculizumab), biosimilar to Alexion’s Soliris®.  Epysqli is indicated for the treatment of adults and children with paroxysmal nocturnal haemoglobinuria.  According to Samsung Bioepis, Epysqli™ i...

A Takeda study published in the New England Journal of Medicine found that vedolizumab was more effective than a placebo at inducing remission in patients with chronic pouchitis after undergoing ileal pouch–anal anastomosis (IPAA) for ulcerative colitis (UC).  31% of patien...

Two biosimilars are on the July 2023 PBAC meeting agenda seeking to be PBS reimbursed for Australia:

Cipla Australia has applied to list Ardalicip®, biosimilar to AbbVie’s Humira® (adalimumab), which was developed by Alvotech (AVT02)
Juno Pharmaceuticals ha...

The UK’s National Institute for Heath Care and Excellence (NICE) has recommended the use of MSD’s Keytruda® (pembrolizumab) for advanced cervical cancer in the NHS, funded by the Cancer Drugs Fund.  This is the first immunotherapy drug for an advanced form of the dise...