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Genentech and Tanvex BioPharma filed a joint notice of settlement in the District Court of the Southern District of California, notifying the court that they have reached an agreement-in-principle to resolve all pending claims in relation to their dispute over Tanvex’s BLA ...

Korea Biomedical Review reported that Celltrion has obtained approval from Health Canada for CT-P16/Vegzelma® (biosimilar bevacizumab) for the same indications as Avastin®.  Celltrion obtained approval for Vegzelma in the US in September 2022.  Vegzelma is Celltrion’s third...

Lannett provided an update on its biosimilar insulin aspart and insulin glargine products. Lannett reported that its study of its biosimilar insulin aspart product indicated that the product was highly comparable with NovoLog®.  Lannett announced that it plans to file the B...

Samsung Bioepis announced that Health Canada has approved its high concentration, citrate-free (100mg/mL) Hadlima® (biosimilar adalimumab) following FDA approval in August 2022.

Hikma Pharmaceuticals announced that is has signed an exclusive licensing agreement with Celltrion for Vegzelma® (biosimilar bevacizumab CT-P16) for MENA (Middle East and North Africa) markets.  Vegzelma is approved in the US and CA, and is the seventh biosimilar to be lice...

Alteogen announced that it has entered into an exclusive licence agreement with Sandoz for the use of ALT-B4 (novel hyaluronidase derived using Alteogen’s Hybrozyme™ technology) to develop a subcutaneous version of an undisclosed Sandoz biosimilar product.  The agreement al...

Amgen’s Amgevita® is due to become the first biosimilar adalimumab in the US market, with a launch possible from 31 January 2023, in accordance with its settlement agreement with AbbVie.  Amgevita was launched in Europe in 2018, Canada in 2021 and Australia in 2021.

The Korea Herald reported that Samsung Bioepis has brought forward its interchangeability study of Hadlima® (biosimilar adalimumab). Samsung had previously announced that it would complete the study by September 2023, however now plans to complete the study in May 2023.  Sa...

A new study published in the Journal of Orthopaedic Translation reported that LY06006 (biosimilar denosumab) might be an effective treatment for osteoporosis.  The study also reported that LY06006 was generally safe and well tolerated without unexpected reactions, similar t...

OncoC4 announced that the first patient has been dosed in Ph II trials of ONC-392 (nextgen target-preserving anti-CTLA-4 antibody) and Keytruda® (pembrolizumab) in patients with platinum-resistant ovarian cancer.  The study is sponsored by OncoC4 in collaboration with Merck...