FDA approves generic teriparatide and levetiracetam

Genéricos/Novedades | Posted 06/02/2024 post-comment0 Post your comment

Two generic versions of osteoporosis treatment, Forteo/Forsteo (teriparatide injection), developed by Teva and Ambio, were approved by the US Food and Drug administration (FDA) in November and December 2023. Although teriparatide is a biological, the new products have been produced synthetically and are therefore generic versions and not biosimilars, of the originator. In addition, Strides Pharma has received approval for its generic seizure medication, levetiracetam.

Teriparatide Forteo V21D02

Teriparatide generic drug approvals
The originator product is Eli Lilly’s Forteo/Forsteo (teriparatide), a recombinant form of parathyroid hormone (PTH). Teriparatide is an effective anabolic, i.e. bone growing agent. It is therefore used for the treatment of osteoporosis in postmenopausal women and men at high risk for fracture and for glucocorticoid-induced osteoporosis in men and postmenopausal women [1]. Forteo had annual sales of US$609 million as of July 2023, according to IQVIA data.

Teriparatide is administered as a subcutaneous injection in the thigh or abdominal region via a pre-filled pen containing 250 micrograms (mcg) per millilitre of the drug. Each pen can deliver 28 doses of 20 mcg medicine.

Back in October 2019, US-based biotech firm Pfenex announced that it had received FDA’s approval for its follow-on biological teriparatide (PF708) [2]. 

Teva’s generics equivalent of Forteo utilizes the Antares Pharma, Inc multi-dose pen device. Antares (a subsidiary of Halozyme Therapeutics, Inc) and Teva are parties to an exclusive license, development and supply agreement for the Teriparatide auto injector product that will be marketed by Teva in the US and Europe. The Ambio product will be marketed by Apotex in the US market.

Levetiracetam generic drug approval
Strides levetiracetam Oral Solution USP, has been approved as 100 mg/mL oral suspension for the treatment of seizures. It is bioequivalent and therapeutically equivalent to the reference listed drug Keppra Oral Solution of UCB. 

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of teriparatide [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 6]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-teriparatide
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves Pfenex’s follow-on teriparatide product [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Feb 6]. Available from: www.gabionline.net/biosimilars/news/FDA-approves-Pfenex-s-follow-on-teriparatide-product

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