Significant biosimilar activities this week include:
11 Dec 22 | New study reports glofitamab is effective in diffuse large B-cell lymphoma
A new Roche study published in the New England Journal of Medicine reported that first in class bispecific (anti-CD20/anti-CD3) antibody glofitamab [CD20-TCB, also known as RG6026] is effective in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Australia’s Peter MacCallum Cancer Centre played a major role in this study, treating the first patients in the world with glofitamab. Roche’s glofitamab is yet to be approved, but it has received orphan drug status in Australia and the EU for DLBCL.
11 Dec 22 | Paras Biopharma creates new division for biosimilars “Paras Biologics”
Finland’s Paras Biopharmaceuticals announced the split of its biologics and biosimilars business units, with the establishment of a new division “Paras Biologics” focussed on biosimilars co-development and licensing opportunities. Paras Biopharma will continue to focus on new biologics activities.
09 Dec 22 | US | FDA accepts Biogen aBLA for biosimilar tocilizumab (Genentech’s Actemra®)
Biogen announced that the FDA accepted its aBLA for BIIB800 (biosimilar tocilizumab) referencing Genentech’s Actemra®. This follows the EMA acceptance of Biogen’s MAA for BIIB800 in September 2022. Tocilizumab is an anti-interleukin-6 receptor monoclonal antibody which is indicated for various health conditions including moderate to severe RA in adults as well as juvenile idiopathic polyarthritis and systemic juvenile idiopathic arthritis.
07 Dec 22 | EU | Alvotech and STADA launch Hukyndra® (biosimilar adalimumab) in additional European countries
Alvotech and STADA announced the launch of their high-concentration, citrate free biosimilar adalimumab Hukyndra® in Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia. Hukyndra was first launched in Europe in June 2022, and in Switzerland in September 2022. STADA has commercialisation rights to Hukyndra under a November 2019 strategic agreement with Alvotech.
29 Nov 22 | Biocon completes acquisition of Viatris’ global biosimilars business
Biocon announced that it completed its multi-billion dollar (part equity, part cash) acquisition of Viatris’ global biosimilars business on 29 November 2022. With the closing of the deal, Biocon Biologics has full ownership of collaboration assets, including biosimilar trastuzumab, pegfilgrastim, bevacizumab, insulin glargine, insulin aspart, and pertuzumab, as well as Viatris’ rights to adalimumab, etanercept and aflibercept. Biocon announced that it would acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash in February 2022.
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