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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.

Significant biosimilar activities this week include:

11 Nov 22 | EU | CHMP recommends Dupixent® (dupilimab) for prurigo nodularis

The CHMP recommended the approval of Dupixent® (dupilumab) for the treatment of moderate-to-severe prurigo nodularis who are candi...

Strides’ biologics arm Stelis Biopharma announced that it has obtained a positive CHMP recommendation for its first biosimilar product Kauliv™ (teriparatide, biosimilar to Eli Lily’s Forsteo®) for the treatment of osteoporosis.

Kualiv is the first biosimilar product ...

Alvotech announced the Australian approval for AVT02 (biosimilar adalimumab).  Cipla will supply Alvotech’s product in Australia and New Zealand under a partnership first announced in July 2019 for adalimumab, which was expanded in March 2021 to include 4 additional biosimi...

Biocon announced its financial results for Q2 2022, reporting consolidated revenue growth of 23% year on year.  Biocon subsidiary Biocon Biologics’ acquisition of Viatris’ global biosimilars business is expected to close “soon”.  Biocon announced that its subsidiary B...

Organon launched Ontruzant® (biosimilar trastuzumab) and Aybintio® (biosimilar bevacizumab) in Canada. Ontruzant and Aybintio were developed and manufactured by Samsung Bioepis, under a February 2013 agreement.