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Amneal announced the launch of Releuko® (biosimilar filgrastim) for the treatment of neutropenia. Amneal and Amgen settled their patent dispute in November 2019.  This is the second biosimilar product to be launched by Amneal this year, following the US launch of Alymsys® (...

The FDA announced that it is investigating the risk of severe hypocalcemia with serious outcomes in patients with advanced kidney disease on dialysis treated with Amgen’s Prolia® (denosumab).  According to the announcement, FDA’s review of interim results of ongoing safety ...

Significant biosimilar activities this week include:

18 Nov 22 | US | FDA approves Rezvoglar® (biosimilar insulin glargine) as interchangeable

The FDA approved Eli Lilly’s Rezvoglar® (biosimilar insulin glargine) as an interchangeable biosimilar to Lantus®.  R...

Korea Biomedical Review reported that Celltrion has obtained approval from South Korea’s Ministry of Food and Drug Safety for a domestically manufactured Yuflyma® (biosimilar adalimumab).

The FDA approved Eli Lilly’s Rezvoglar® (biosimilar insulin glargine) as an interchangeable biosimilar to Lantus®.  Rezvoglar was approved as a biosimilar in December 2021.

A Chinese study by Innovent Biologics, Inc. has demonstrated that the combination therapy of sintilimab and bevacizumab biosimilar provided better quality of life for the treatment of hepatocellular carcinoma, albeit at a higher cost ($33,102 vs $21,037 (2021 USD)), compare...

Senator Mike Lee (R-UT) introduced the Biosimilars Red Tape Elimination Bill into the US Senate, which – if implemented, will prohibit the FDA from requiring biosimilars to undergo switching studies to obtain ‘interchangeable’ designation.  Unlike small-molecule drugs, bios...

Korea Biomedical Review reported that Dong-A ST has completed Ph III trials of DMB-3115 (biosimilar ustekinumab).  Dong-A ST reported that it plans to file for regulatory approval in the US and Europe in the first half of 2023.  DMB-3115 has been jointly developed by Dong-A...

Alvotech reported its financial results for the first nine months of 2022, reporting revenue of $59.2 million compared to $2.0 million for the same period in 2021.  Alvotech also announced financing facilities securing gross proceeds of approximately $136 million.