On 28 March 2022, the European Commission (EC) has granted marketing authorization for Fresenius Kabi's oncology biosimilar, Stimufend (pegfilgrastim); and the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 February 2022 that it had recommended granting of marketing authorization for an insulin aspart biosimilar and an insulin human (rDNA) biosimilar.
Fresenius Kabi's Stimufend authorized
Fresenius Kabi's Stimufend (pegfilgrastim) is a biosimilar of Amgen's Neulasta. This is a drug product that stimulates the production of neutrophils and can be used to prevent infection in patients with reduced neutrophil count, such as those receiving chemotherapy.
Stimufend is given specifically to reduce the duration of neutropenia ((low levels of neutrophils, a type of white blood cell) and prevent febrile neutropenia (neutropenia accompanied by fever).
The EC’s marketing authorization of the product comes after the January 2022 positive opinion on the product from the CHMP, who recommended that Stimufend be used to reduce the duration of neutropenia and the incidence of febrile neutropenia after cytotoxic chemotherapy [1].
Stimufend is the company’s first approved molecule in its oncology biosimilar portfolio and its second biosimilar approved in Europe.
Fresenius Kabi has also submitted an application of its pegfilgrastim biosimilar candidate to the US Food and Drug Administration (FDA) and is currently under review.
Positive opinion for two insulin biosimilars
In late February 2022, it was announced that EMA’s CHMP has adopted positive opinions for two insulin biosimilars, Inpremzia and Truvelog Mix 30. This means that the agency has recommended the EC to grant them marketing authorization.
Sanofi-Aventis has developed Truvelog Mix 30, an insulin aspart biosimilar referencing Novo Nordisk’s NovoMix, which was first authorized in the European Union (EU) on 1 August 2000 [2, 3]. The active substance of Truvelog Mix 30 is insulin aspart, an intermediate- or long-acting insulin which is combined with fast-acting insulin and used in diabetes (ATC code: A10AD05). It will be available as a 100 U/mL suspension for injection and is indicated for treatment of diabetes mellitus in adults, adolescents and children over 10 years. A previous version of Truvelog was recommended for approval by EMA’s CHMP on 30 April 2020 [4] and the EC granted marketing authorization on 25 June 2020 [5].
Inpremzia is a human insulin biosimilar referencing Novo Nordisk’s Actrapid [6] which was authorized in the EU on 7 October 2002. Inpremzia is a ready-to-use insulin formulation available as 1 IU/mL solution for intravenous (IV) infusion developed by Celerity Pharmaceuticals, using Biocon Biologics’ biosimilar human insulin drug substance, and is indicated for the treatment of diabetes mellitus.
Insulin lowers blood glucose by facilitating uptake of glucose into muscle and fat cells and by simultaneously inhibiting glucose output from the liver.
The two products are the fifth and sixth approvals for insulin biosimilars for use in the EU.
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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of teriparatide and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-teriparatide-and-pegfilgrastim-biosimilars
2. Derbyshire M. Patent expiry dates for biologicals: 2017 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(1):29-34. doi:10.5639/gabij.2018.0701.007
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of insulin aspart [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-insulin-aspart
4. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of Sanofi’s insulin aspart biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-Sanofi-s-insulin-aspart-biosimilar
5. GaBI Online - Generics and Biosimilars Initiative. EC approval for Sanofi’s insulin aspart biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/Biosimilars/News/EC-approval-for-Sanofi-s-insulin-aspart-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. Biosimilars applications under review by EMA January 2022 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Apr 29]. Available from: www.gabionline.net/biosimilars/general/biosimilars-applications-under-review-by-ema-january-2022
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