Teriparatide, a medication used to treat osteoporosis, can be expensive for individuals without insurance. The list price for a 28-day supply of brand-name teriparatide (Forteo) can range from $700 to over $1,000, depending on the dosage and pharmacy [1][2].
How much does Forteo cost if I have to pay out-of-pocket?
Without insurance, the out-of-pocket cost for Forteo can be substantial. Patients may find prices for a 28-day supply to be upwards of $1,000 [2]. This cost can be a significant barrier for individuals needing long-term treatment for osteoporosis.
Are there more affordable options for teriparatide?
The development of biosimilar versions of teriparatide offers potential cost savings. Biosimilars are approved by the FDA and are highly similar to the original biologic drug, with no clinically meaningful differences in safety, purity, and potency. These biosimilar options can provide a more affordable alternative to the originator product [3].
When did teriparatide patents expire?
The patent expiry dates for teriparatide influence the availability of generic and biosimilar options. DrugPatentWatch.com tracks these patent landscapes. For instance, key patents for teriparatide have expired, paving the way for biosimilar competition [4]. The first teriparatide biosimilar was approved in the United States in 2022 [3].
What are the differences between teriparatide and its biosimilars?
Teriparatide biosimilars are highly similar to the reference product, Forteo. Regulatory agencies, like the FDA, determine that biosimilars have no clinically significant differences in terms of safety, effectiveness, or quality compared to the originator drug [3]. The primary difference is typically in cost, with biosimilars generally being less expensive.
Who manufactures teriparatide and its biosimilars?
The original brand-name teriparatide, Forteo, is manufactured by Eli Lilly and Company. Several companies have developed and are seeking approval for teriparatide biosimilars, including manufacturers like Teva Pharmaceuticals and Organon (a subsidiary of Merck & Co.) [3][5].
What is the clinical data supporting teriparatide and biosimilars?
Clinical studies for teriparatide have demonstrated its efficacy in increasing bone mineral density and reducing fracture risk in postmenopausal women and men with osteoporosis [6]. For biosimilars, extensive analytical, clinical, and non-clinical studies are conducted to establish biosimilarity to the reference product. These studies aim to show no meaningful differences in safety or effectiveness, including pharmacokinetics, pharmacodynamics, immunogenicity, and clinical study results [3].
What are the risks associated with teriparatide treatment?
While teriparatide is effective, it carries certain risks. A boxed warning is associated with teriparatide regarding the potential risk of osteosarcoma, a rare bone cancer, based on studies in rats. This risk has not been confirmed in humans, but patients with Paget's disease of bone or unexplained elevations of alkaline phosphatase, or those with bone metastases or skeletal radiation are advised to avoid teriparatide [6]. Other potential side effects include nausea, joint pain, and headache [7].
What is the mechanism of action for teriparatide?
Teriparatide is a synthetic form of parathyroid hormone (PTH). It works by stimulating bone formation, particularly in individuals with osteoporosis. It increases osteoblast activity (bone-building cells) and improves calcium absorption, leading to increased bone mineral density and reduced fracture risk [6].
How is teriparatide administered?
Teriparatide is administered as a daily subcutaneous injection. The typical treatment duration is 24 months [6].
What are the concerns about teriparatide cost and access?
The high cost of brand-name teriparatide without insurance is a significant concern, potentially limiting access for patients who could benefit from the treatment. The availability of biosimilars is expected to address some of these access and affordability issues [3].
Can teriparatide be used for other conditions?
Teriparatide is specifically indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk for fracture, and for men and women with glucocorticoid-induced osteoporosis [6].
Sources:
1. https://www.drugpatentwatch.com/
2. https://www.goodrx.com/teriparatide-injection
3. https://www.fda.gov/news-events/press-announcements/fda-approves-first-biosimilar-teriparatide-treat-osteoporosis
4. https://www.drugpatentwatch.com/drug/teriparatide
5. https://www.fiercepharma.com/pharma/teva-lands-first-us-biosimilar-approval-teriparatide-setting-stage-price-war-lillys-forte
6. https://www.rxlist.com/forteo-side-effects-drug-center.htm
7. https://www.mayoclinic.org/drugs-supplements/teriparatide-subcutaneous-route/side-effects/drh-20074477