Pfenex and Alvogen announced this week that they have entered into agreements to develop and commercialize PF708, a follow-on teriparatide product referencing Forteo, for the treatment of osteoporosis, in the European Union, some countries in the Middle East and North Africa, and other territories.
Pfenex and Alvogen announced this week that they have entered into agreements to develop and commercialize PF708, a follow-on teriparatide product referencing Forteo, for the treatment of osteoporosis, in the European Union, some countries in the Middle East and North Africa, and other territories.
Subject to regulatory approval, the drug will be commercialized in the European Union and Switzerland by Theramex, in the Middle East and North Africa by SAJA, and in the remaining territories by Alvogen’s current and future commercialization partners.
Under the agreement, Alvogen will assume responsibility for the local activities carried out by Teramex, SAJA, and other commercialization partners, and will oversee clinical development, regulatory submissions, litigation, manufacturing, and commercialization activities. Pfenex may be eligible to receive a gross profit split of up to 60% on sales of the product.
Pfenex is currently awaiting regulatory approval for its drug, and in the United States, it submitted an application to the FDA for consideration in December 2018. Whereas in the European Union, subsequent-entry versions of teriparatide are regulated as biosimilars, in the United States, they are treated as follow-on products. Although many products treated as drugs by the FDA (like insulins and hormones) will be regulated as biologics beginning on March 23, 2020, teriparatide is not on the FDA’s preliminary list of products that will make that transition. Thus, the Pfenex product is expected to remain a follow-on in the US context.
As such, Pfenex has submitted an 505(b)(2) New Drug Application (NDA) rather than an abbreviated Biologics License Application for the product. A key feature of 505(b)(2) NDAs is that the pathway allows manufacturers to submit their drug products for FDA review by including data collected by the reference product sponsor, although, like the biosimilar approval pathway, the follow-on must be shown to be similar to the reference through bioanalytical testing, preclinical studies, and clinical trials.
In Pfenex’s case, it submitted a data package that included a 24-week study in 181 patients with osteoporosis. The study’s primary end point was the incidence of antidrug antibodies (ADAs) at week 24, and it found no differences in the number of patients who developed ADAs while taking the reference drug or while taking PF708.
Pfenex says that it expects to be able to launch PF708 in the United States as early as the fourth quarter of 2019.
HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain
November 28th 2023Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
Biosimilar Business Roundup for October 2023—Podcast Edition
November 5th 2023On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
November 22nd 2023Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).
Biosimilars Business Roundup For August 2023—Podcast Edition
September 5th 2023On this episode, we’re giving an overview of some of the biggest stories in the business space regarding biosimilars, like the approval of the first neurology biosimilar, growth projections from company quarterly expense reports, and some analyses about the health of the market.
AMCP Nexus: Panelists Share Current Scope of Biosimilar Industry
October 26th 2023Panelists at the Academy of Managed Care Pharmacy (AMCP) Nexus meeting chronicled the current state of the US biosimilar market, including current policies impacting the market, recent regulatory decisions, and the developing arguments around requirements for clinical efficacy studies.
Report: Conflicting Guidelines, Rebate Walls Are Major Factors Determining Biosimilar Uptake
October 24th 2023Samsung Bioepis’ most recent biosimilar market report identified inconsistent medical guidelines, challenges with access and rebates, and acute vs chronic treatment duration as major factors influencing biosimilar uptake in the United States.