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Amgen announced that the FDA has approved a new indication for Riabni™ (biosimilar rituximab) – in combination with methotrexate, for adults with rheumatoid arthritis who have had an inadequate response to TNF antagonist therapies.  Riabni™ is Amgen’s fifth approved U...

The PTAB instituted an inter partes review filed by Fresenius Kabi against US Patent 9,750,752 (‘752 patent) owned by Chugai Seiyaku Kabushiki Kaisha and Hoffman-La Roche.  The ‘752 patent is directed at methods of treating giant cell arteritis by subcutaneously administeri...

Biogen and Samsung Bioepis announced the launch of Byooviz™ (biosimilar ranibizumab) in the US.  Biogen announced that Byooviz will be available at a discount of 40% compared to Lucentis®.  Byooviz was developed under a partnership between Biogen and Samsung Bioepis, and th...

Civica announced that is has selected Profil as its clinical trial partner to support the development of its affordable insulin initiative.  In March 2020, Civica announced its plan to manufacture biosimilar insulins glargine, lispro and aspart.  Civica plans to set a maxim...

Roche announced that Health Canada has approved Vabysmo® (faricimab) for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME).  This is the first approved treatment in Canada for wet AMD and DME that targets both VEGF-A ...

Lannett provided an update on its pivotal clinical trials of biosimilar insulin glargine.  Lannett announced that half of the subjects have received the first two doses in healthy volunteer pharmacokinetics (PK) and pharmacodynamics (PD) study.  No serious adverse events ha...

Novartis announced that the FDA has approved Beovu® (brolucizumab) for the treatment of diabetic macular edema (DME).  Beovu® is also indicated for the treatment of wet age-related macular degeneration.

Sandoz launched Act4Biosimilars a new initiative aimed at improving patient access to biosimilars by facilitating greater approvability, accessibility, acceptability and affordability.  The mission of Act4Biosimilars is to increase biosimilar use by 30% in 30+ countries by ...

Outlook Therapeutics announced that it has voluntarily withdrawn its BLA for ONS-5010/LYTENAVA™ (proposed biosimilar bevacizumab) after the FDA requested additional information.  Outlook Therapeutics announced that it is actively working to respond to the FDA’s request and ...