BioBlast® w/e 03 June 2022: featuring Outlook’s bevacizumab, Lannett’s insulin glargine, Henlius’ biosims, Novartis’ brolucizumab, Roche’s faricimab, Biogen/Samsung Byooviz™ & GBMA Biosimilars Awareness Week

by , | Jun 6, 2022

24 May 22 | BR | Shanghai Henlius Biotech signs license agreement for rituximab and trastuzumab biosims

Shanghai Henlius Biotech announced that it has entered into a semi-exclusive license agreement with Abbott Operations Uruguay for the commercialisation of Hanlikang® (biosimilar rituximab) and Hanquyou® (biosimilar trastuzumab) in Brazil.

30 May 22 | AU | GBMA hosts 2022 Biosimilars Awareness Week

Australia’s Generic and Biosimilar Medicines Association hosts 2022 Biosimilar Awareness Week with the key focus on delivering equitable access to affordable medicines to all Australians.

31 May 22 | US | Outlook Therapeutics voluntarily withdraws its BLA for ONS-5010/LYTENAVA™ (bevacizumab)

Outlook Therapeutics announced that it has voluntarily withdrawn its BLA for ONS-5010/LYTENAVA™ (proposed biosimilar bevacizumab) after the FDA requested additional information.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 plans to re-submit a revised BLA by September 2022.

31 May 22 | Sandoz launches new initiative ‘Act4Biosimilars’

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 2030.

01 Jun 22 | US | Novartis | FDA approves Beovu® (brolucizumab) for the treatment of DME

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.

01 Jun 22 | Lannett provides update on biosimilar insulin glargine trials

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 have been reported, with the study due to finish at the end of 2022.  Lannett also announced that it plans to submit its BLA for the project in early 2023, with a potential launch in the first half of 2024.

01 Jun 22 | CA | Roche | Health Canada approves Vabysmo® (faricimab) for AMD and DME

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 and Ang-2.

02 Jun 22 | US | Biogen and Samsung Bioepis launch Byooviz™ (biosimilar ranibizumab) in the US

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 this launch is the first US biosimilar arising from the partnership.

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