BioBlast® w/e 10 June 2022: featuring Alvotech/Stada’s adalimumab, Amgen’s rituximab, Fresenius’ tocilizumab IPR, dostarlimab study and Civica’s insulin

by , | Jun 15, 2022

02 Jun 22 | Civica selects Profil as clinical trial partner for affordable insulin initiative

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 maximum recommended consumer price of no more than $30 per vial, or $55 for a box of five pen cartridges.

03 Jun 22 | US | PTAB institutes IPR on tocilizumab patent

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 administering tocilizumab.  This is the sixth IPR instituted by PTAB regarding tocilizumab patents arising from Fresenius Kabi challenges.

06 Jun 22 | US | FDA approves additional indication for Amgen’s Riabni™ (rituximab)

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 US biosimilar, and was  approved in December 2020 for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.

06 Jun 22 | Small GSK study of dostarlimab shows 100% remission in rectal cancer

A new study sponsored by GSK presented at the ASCO annual meeting reported on a small trial of 14 patients with locally advanced mismatch repair-deficient rectal cancer.  The researchers reported that 6 months of treatment with dostarlimab led to clinical complete responses in 100% of the patients, removing the need for chemotherapy, radiation or surgery.

09 Jun 22 | EU | Alvotech and STADA launch citrate-free 100mg/ml biosimilar adalimumab in Europe

Alvotech announced the launch of Hukyndra® (citrate-free 100mg/ml biosimilar adalimumab) in Europe by its partner STADA.  The initial launch regions include France, Germany, Finland, and Sweden, with further launches scheduled “over the coming months”.  Whilst Hukyndra® is the fifth biosimilar to be marketed by STADA, it is the first arising from its partnership with Alvotech which covers seven biosimilar products.

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