FDA approves generic teriparatide and levetiracetam

Generics/News | 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 U.S. 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. 

Related articles
EMA approves bevacizumab and teriparatide biosimilars

Teriparatide biosimilar Terrosa launched in Europe

Generics in seizure control

LATIN AMERICAN FORUM
The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish.

View the latest headline article: La FDA aprueba el biosimilar de bevacizumab Avzivi

Browse the news in the Latin American Forum!

Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative.

FORO LATINOAMERICANO
Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español.

Ver el último artículo de cabecera: La FDA aprueba el biosimilar de bevacizumab Avzivi

!Explore las noticias en el Foro Latinoamericano!

Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa. 

 

References
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

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2024 Pro Pharma Communications International. All Rights Reserved.

comment icon Comments (0)
Post your comment
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010