FDA approves insulin glargine biosimilar Semglee

Biosimilares/Novedades | Posted 19/06/2020 post-comment0 Post your comment

US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 11 June 2020 that it had received approval from the US Food and Drug Administration (FDA) for its insulin glargine biosimilar Semglee (MYL‑1501D).

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Semglee is a proposed biosimilar to Sanofi’s Lantus (insulin glargine), which generated an estimated US$6.4 billion in net sales income globally for Sanofi in 2015, before the advent of biosimilars [1]. The patents on Lantus expired in 2014 in both Europe and the US [2].

Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar level of those with diabetes. It consists of microcrystals that slowly release insulin, giving a long duration of action of 18 to 26 hours. Insulin glargine is indicated for the treatment of diabetes mellitus in adults, adolescents and children aged two years and above.

Semglee was approved as a drug product under the 505(b)(2) NDA pathway and is now deemed a biological under section 351(a) in accordance with the Biologics Price Competition and Innovation Act in line with other insulin products.

Semglee has been approved for all of the same indications as the originator biological, Lantus. It will be available in vial and pre-filled pen presentations to control high blood sugar in adults with type 2 diabetes and adult and paediatric patients with type 1 diabetes.

The FDA approval of Semglee on 11 June 2020 was based on a comprehensive analytical, preclinical and clinical programme, which confirmed the pharmacokinetic (PK)/pharmacodynamic (PD), efficacy, safety and immunogenicity of Semglee in comparison to Lantus in patients with type 1 and type 2 diabetes. The data provided to FDA included the global INSTRIDE clinical studies, which, according to Mylan, ‘demonstrated no difference in safety, efficacy and immunogenicity of Semglee in comparison to the reference product, Lantus, in type 1 and type 2 diabetes’.

Semglee has not been approved as an interchangeable product. However, Mylan President Rajiv Malik said that he believed ‘that the strong comprehensive analytical and clinical program supporting the approval of Semglee will be central to our continued work to achieve interchangeable product status, with the potential to further reduce the cost burden for patients’.

The approval of Semglee brings the list of Biocon/Mylan’s aproved biosimilars up to three in the US. The pair gained approval for Ogivri (trastuzumab-dkst) in December 2017 and for Fulphila (pegfilgrastim-jmdb) in June 2018 [3].

Semglee was also approved in Europe in March 2018 [4].

Related article
Insulin biosimilar Semglee gains EC and Australian approval

1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of insulin glargine [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-insulin-glargine
2. Derbyshire M. Patent expiry dates for best-selling biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jun 19]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Mylan, US FDA

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