Extension of indications and manufacturing approval for biologicals in the US

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Extension of indications and manufacturing approval for biologicals in the US

Biosimilars/General | Posted 14/09/2018 0 Post your comment

Filgrastim biosimilar Granix (tbo-filgrastim) has been approved for extended indications and Samsung BioLogics has received approval to manufacture a monoclonal antibody drug product.

Teva Pharmaceutical Industries (Teva) announced on 6 August 2018 that FDA had approved Granix (tbo-filgrastim) Injection for a new vial presentation and indication in paediatric patients one month and older. Granix is indicated to reduce the duration of severe neutropenia in adult and paediatric patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Teva launched Granix (short-acting G-CSF) in the US on 11 November 2013, marking the entry of the first new G-CSF to the US market in more than 10 years. Teva received FDA approval for Granix on 29 August 2012 [1].

Teva currently markets filgrastim in Europe under the trade name Tevagrastim, a biosimilar of Amgen’s Neupogen (filgrastim). Tbo-filgrastim was filed in the US as a Biologics License Application (BLA) since a biosimilars approval pathway had not been established at the time of submission.

Samsung BioLogics, the specialized biotechnology arm of Samsung, announced on 25 July 2018 that it had been licensed by the US Food and Drug Administration (FDA) to manufacture a monoclonal antibody drug product at its first plant. The company did not disclose the name of the product; but did say that the approval follows previous approvals by the European Medicines Agency (EMA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

Samsung BioLogics currently has a total of 16 global approvals for manufacturing drug substances in its two manufacturing facilities. This includes two approvals from EMA and one from PMDA. The company also expects a further global approval before the end of 2018.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Teva launches new biologicals in Europe and US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 14]. Available from: www.gabionline.net/Biosimilars/News/Teva-launches-new-biologicals-in-Europe-and-US

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Source: Samsung BioLogics, Teva