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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...

Daiichi Sankyo announced that its Enhertu® (trastuzumab deruxtecan) has been approved by Japan’s Ministry of Health, Labour and Welfare for the treatment of adults with HER2 low unresectable or recurrent breast cancer after prior chemotherapy.  The approval was granted base...

Eli Lilly has announced a $1B investment to build a new biotech facility in Raheen (Ireland) for the manufacture of on-market monoclonal antibodies (mAbs).  The site is expected to start production of Lilly’s new clinical products in 2026.  The company said that this invest...

The Supreme Court heard the opening oral arguments in the Amgen v Sanofi case (2020-1074; No. 21-757) this week.  The case arises from a Federal Court decision which invalidated claims in two Amgen patents (8,829,165 and 8,859,741) relating to Repatha® (evolocumab) which it...