The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 26 June 2020 that it had recommended granting marketing authorization for the bevacizumab biosimilar Aybintio and for the teriparatide biosimilars Livogiva and Qutavina.
Aybintio (SB8) is produced by Korea-based Samsung Bioepis. The company had its candidate bevacizumab biosimilar accepted for regulatory review by EMA in June 2019 [1] following the completion, in October 2018, of a phase III trial for SB8 in lung cancer patients [1].
The CHMP has recommended that Aybintio be approved for the treatment of certain cancers. Sandoz said that this includes ‘treatment of the same types of cancer as reference bevacizumab’.
The positive CHMP opinion for Aybintio has been based on a comprehensive data package and totality of evidence which included analytical, pharmacokinetic (PK) and clinical data, as well as pharmacology and toxicology data. These data demonstrated that Aybintio and reference bevacizumab are highly similar with no clinically meaningful differences.
Aybintio is the second oncology biosimilar developed by Samsung Bioepis and will mark the fifth biosimilar that the company has had approved in Europe. The company gained European approval for Benepali (etanercept), Flixabi (infliximab), Imraldi (adalimumab) and Ontruzant in January 2016, May 2016, August 2017 and November 2017, respectively [3]. The company also submitted a Biologics License Application (BLA) to the US for Aybintio in September 2019 and is currently under review by the US Food and Drug Administration (FDA).
Samsung Bioepis is also collaborating with 3SBio for copy biologicals of bevacizumab in China [4].
The teriparatide biosimilars Livogiva and Qutavina are produced by Theramex Ireland and EuroGenerics Holdings. The CHMP has recommended that the products be approved for the treatment of osteoporosis.
There are already two teriparatide biosimilars approved for use in the European Union. Stada Arzneimittel’s Movymia and Gedeon Richter’s Terrosa both received EC approval in January 2017 [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA accepts application for bevacizumab biosimilar from Samsung Bioepis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 24]. Available from: www.gabionline.net/Biosimilars/News/EMA-accepts-application-for-bevacizumab-biosimilar-from-Samsung-Bioepis
2. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis starts phase III trial for bevacizumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 24]. Available from: www.gabionline.net/Biosimilars/News/Samsung-Bioepis-starts-phase-III-trial-for-bevacizumab-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Samsung Bioepis makes deals for copy biologicals in China [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 24]. Available from: www.gabionline.net/Pharma-News/Samsung-Bioepis-makes-deals-for-copy-biologicals-in-China
5. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 24]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
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Source: EMA, Samsung Bioepis
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