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EMA approves biosimilars of insulin glargine and teriparatide Posted 18/11/2016

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 11 November 2016 that it had recommended granting of marketing authorization for an insulin glargine biosimilar and two teriparatide biosimilars.

The biosimilar insulin glargine, which will be called Lusduna (MK-1293), is produced by US pharma giant Merck (known as MSD outside the US and Canada). The drug is a biosimilar of French drugmaker Sanofi’s diabetes drug Lantus (insulin glargine). The first biosimilar insulin glargine, Abasria (LY2963016), was approved for use in the European Union in September 2014 [1].

The teriparatide biosimilars, Movymia and Terrosa, are produced by German generics giant Stada Arzneimittel (Stada) and Hungary-based Gedeon Richter (Richter), respectively. The drugs are biosimilars of Eli Lilly’s osteoporosis treatment Forteo/Forsteo (teriparatide).

Teriparatide is a recombinant form of parathyroid hormone. It is an effective anabolic, i.e. bone growing, agent used in the treatment of some forms of osteoporosis. Sales of Eli Lilly’s blockbuster drug Forteo/Forsteo were US$1.3 billion for 2015.

Stada has in-licensed its teriparatide biosimilar from Richter-Helm BioTec, which developed the product [2]. Stada already markets a biosimilar in Europe, Silapo (epoetin zeta) [3] and has also in-licensed biosimilar filgrastim (Grastofil) and adalimumab products from Canada-based Apotex [4] and biosimilars specialist mAbxience [5], respectively. Stada also made a deal with Richter in 2011 for biosimilars of two monoclonal antibody products, rituximab and trastuzumab, which are used to treat cancer and autoimmune diseases [6]. In December 2015, Richter also submitted a marketing application to EMA for its proposed biosimilar to Amgen’s Neulasta (pegfilgrastim) [7].

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References
1. GaBI Online - Generics and Biosimilars Initiative. European approval for biosimilar insulin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Biosimilars/News/European-approval-for-biosimilar-insulin
2. GaBI Online - Generics and Biosimilars Initiative. Stada in-licenses teriparatide biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Biosimilars/News/Stada-in-licenses-teriparatide-biosimilar
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
4. GaBI Online - Generics and Biosimilars Initiative. Stada in-licenses biosimilar filgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Biosimilars/News/Stada-in-licenses-biosimilar-filgrastim
5. GaBI Online - Generics and Biosimilars Initiative. Stada to in-license adalimumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Biosimilars/News/Stada-to-in-license-adalimumab-biosimilar
6. GaBI Online - Generics and Biosimilars Initiative. Stada and Richter to collaborate on biosimilar development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Biosimilars/News/Stada-and-Richter-to-collaborate-on-biosimilar-development
7. GaBI Online - Generics and Biosimilars Initiative. Richter and DM Bio make deal for trastuzumab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 18]. Available from: www.gabionline.net/Pharma-News/Richter-and-DM-Bio-make-deal-for-trastuzumab-biosimilar

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Source: EMA

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