FDA approves Pfenex’s follow-on teriparatide product

Biosimilars/News | Posted 11/10/2019 post-comment0 Post your comment

US-based biotech firm Pfenex announced on 7 October 2019 that it had received approval from the US Food and Drug Administration (FDA) for its follow-on teriparatide product (PF708).

Bone cells V17C04

Teriparatide is a recombinant form of parathyroid hormone (PTH). It is identical to a portion of human PTH and intermittent use activates osteoblasts more than osteoclasts, which leads to an overall increase in bone. This makes it an effective anabolic, i.e. bone growing, agent. It is therefore used for the treatment of osteoporosis in post-menopausal women and men at high risk for fracture and for glucocorticoid-induced osteoporosis in men and post-menopausal women.

PF708 is a proposed follow-on product to Eli Lilly’s Forteo/Forsteo (teriparatide), which had worldwide sales of US$1.6 billion in 2018, before the advent of biosimilars. The patents on Forteo/Forsteo expired in Europe and the US in August 2019 [1].

Pfenex’s follow-on teriparatide product was approved via FDA’s abbreviated 505(b)(2) pathway, not via the biosimilar pathway. The 505(b)(2) pathway allows sponsors to cite findings that previously approved drugs are safe or effective to support the product’s safety or effectiveness.

PF708 has been approved for the same indications as Forteo, i.e. for the treatment of osteoporosis in certain patients at high risk for fracture. The approval marks the first follow-on teriparatide product to be approved by FDA and it is the first commercial product approval for Pfenex.

Pfenex submitted its application for approval for PF708 in the US to FDA back in December 2018. The approval was based a data package that included data from a 24-week study in 181 patients with osteoporosis. Results from the study, according to Pfenex, demonstrated comparable effects, with no statistically significant differences observed, between follow-on and reference teriparatide. There were no significant differences in the number of patients who experienced adverse events (AEs), or in the severity of AEs, between follow-on and reference teriparatide.

In June 2018, Pfenex made an agreement with Alvogen granting Alvogen exclusive rights to commercialize PF708 in the US [2].

In Europe, teriparatide biosimilars from Stada Arzneimittel (Movymia) and Gedeon Richter (Terrosa) were approved by the European Commission in January 2017 [3].

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1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. Pfenex makes biosimilar deals with Alvogen and NT Pharma [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 11]. Available from: www.gabionline.net/Pharma-News/Pfenex-makes-biosimilar-deals-with-Alvogen-and-NT-Pharma
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Oct 11]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

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Source: Pfenex

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