BioBlast w/e 18 Nov 22: Eli Lilly’s interchangeable insulin glargine, Organon trastuzumab and bevacizumab launches, Biocon Viatris’ biosimilar asset acquisition, Janssen guselkumab study, NICE Keytruda® recommendation, Stelis’ teriparatide

by , | Nov 21, 2022

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®.  Rezvoglar was approved as a biosimilar in December 2021.

18 Nov 22 | KR | Celltrion obtains second approval for Yuflyma® (biosimilar adalimumab)

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).

17 Nov 22 | Dong-A ST completes Ph III trials of DMB-3115 (ustekinumab biosimilar)

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 ST and Meiji Seika Pharma.  Intas Pharma and Meiji/Dong-A ST signed a commercialisation agreement in July 2021 for DMB-3115.

16 Nov 22 | Alvotech publishes financial results for the first nine months of 2022

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.

14 Nov 22 | CA | Organon launches trastuzumab and bevacizumab biosimilars in Canada

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.

14 Nov 22 | Biocon announces financial results for Q2 2022

Biocon announced its financial results for Q2 2022, reporting consolidated revenue growth of 23% year on year.  Biocon’s acquisition of Viatris’ global biosimilars business is expected to close “soon”.  Biocon announced that it would acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash in February 2022.

14 Nov 22 | Alvotech announces Australian approval for AVT02 (biosimilar adalimumab)

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 biosimilars: aflibercept, ustekinumab, denosumab and golimumab biosimilars.

14 Nov 22 | EU | Stelis Biopharma obtains positive CHMP opinion for Kauliv™ (biosimilar teraparatide)

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 developed in house by Stelis.  Stelis will make Kualiv, which it has already licensed across 20 countries, in Bangalore.  According to the announcement, the product “will generate incremental revenues for the Company starting FY24”.

Stelis is developing teriparatide, insulin glargine (biosimilar to Sanofi’s Lantus®), insulin lispro (biosimilar to Eli-Lilly’s Humalog®), insulin aspart (biosimilar to NovoNordisk’s Novolog®) and another “recently filed peptide for diabetes”.

11 Nov 22 | Janssen publishes Ph III results of Tremfya® (guselkumab) for psoriatic arthritis

Janssen published data from Ph III trials of Tremfya® (guselkumab) for the treatment of psoriatic arthritis.  Janssen reported that early skin and enthesitis responses predicted longer-term clinical response, including disease remission at week 52.

08 Nov 22 | UK | NICE recommends Keytruda® (pembrolizumab) for triple-negative breast cancer

NICE published final draft guidance recommending Keytruda® (pembrolizumab) for the treatment of triple-negative breast cancer.  NICE expects to publish its final guidance on pembrolizumab for treating early or locally advanced triple-negative breast cancer next month (December 2022).

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