Teriparatide- Biosimilar Insight, 2022

DelveInsight's, "Teriparatide- Biosimilar 2022," report provides comprehensive insights about 10+ companies and 10+ marketed and pipeline drugs in Teriparatide Biosimilars landscape. It covers the marketed and pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Teriparatide Understanding

Teriparatide: Overview

Teriparatide (recombinant human parathyroid hormone) is a potent anabolic agent used in the treatment of osteoporosis. It is manufactured and marketed by Eli Lilly and Company. For the treatment of osteoporosis in men and postmenopausal women who are at high risk for having a fracture. Also used to increase bone mass in men with primary or hypogonadal osteoporosis who are at high risk for fracture. Teriparatide is the portion of human parathyroid hormone (PTH), amino acid sequence 1 through 34 of the complete molecule which contains amino acid sequence 1 to 84. Endogenous PTH is the primary regulator of calcium and phosphate metabolism in bone and kidney. Daily injections of teriparatide stimulates new bone formation leading to increased bone mineral density.

Teriparatide Biosimilars: Drugs Chapters

This segment of the Teriparatide report encloses its detailed analysis of various drugs in different stages of clinical development, including marketed, phase III, II, I and preclinical. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Teriparatide Biosimilars: Marketed Drugs

• Bonsity: Pfenex

Bonsity (teriparatide) is a parathyroid hormone analog (PTH 1-34) indicated for the treatment of osteoporosis in certain patients at high risk for fracture. Bonsity is approved in the U.S. under the 505(b) regulatory pathway, with Forteo (teriparatide injection) as the reference drug. Bonsity is indicated for:

• Treatment of postmenopausal women with osteoporosis at high risk for fracture
• Increase of bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture
• Treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy at high risk for fracture.

Further product details are provided in the report……..

Teriparatide: Therapeutic Assessment

This segment of the report provides insights about the different Teriparatide biosimilars segregated based on following parameters that define the scope of the report, such as:

• Major Players in Teriparatide

There are approx. 10+ key companies which are developing the therapies for Teriparatide.

• Phases

DelveInsight's report covers around 10+ products under different phases of clinical development like

• Marketed stage products
• Late stage products (BLA Filed and Phase III)
• Mid-stage products (Phase II and
• Early-stage products (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Teriparatide pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Subcutaneous
• Intravenous
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibodies
• Peptide
• Protein
• Small molecule
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Teriparatide: Pipeline Development Activities

The report provides insights into different therapeutic candidates in marketed, phase III, II, I and preclinical stage. It also analyses Teriparatide biosimilars drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Teriparatide biosimilar drugs.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Teriparatide R&D. The therapies under development are focused on novel approaches to treat/improve Teriparatide.
• In June 2020, Pfenex announced that its commercialization partner, Alvogen, has launched Teriparatide Injection in the United States. Teriparatide Injection (also referred to as PF708 and Bonsity) is a prescription medicine approved for several uses, including in postmenopausal women with osteoporosis who are at high risk for having bone fractures.
• In August 2019, Gedeon Richter announced that it has launched its biosimilar teriparatide, Terrosa in Europe. The product is approved in adults for the same indications as Eli Lilly's Forsteo, i.e. used for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fracture and treatment of osteoporosis associated with sustained systemic glucocorticoid therapy in women and men at increased risk for fracture. In postmenopausal women, a significant reduction in the incidence of vertebral and non vertebral fractures but not hip fractures has been demonstrated.

Teriparatide Biosimilars Report Insights

• Teriparatide Biosimilar Pipeline Analysis
• Therapeutic Assessment
• Sales Assessment
• Unmet Needs
• Impact of Drugs

Teriparatide Biosimilar Report Assessment

• Marketed Product profiles
• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Sales Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Teriparatide Biosimilars?
• How many Teriparatide biosimilars are developed by each company?
• How many emerging biosimilars are in mid-stage, and late-stage?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Teriparatide biosimilars therapeutics?
• What are the clinical studies going on for Teriparatide biosimilars and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Pfenex
• CinnaGen
• Corium International
• Rhein Minapharm Biogenetics
• Stada Arzneimittel
• Biosidus
• Amega Biotech
• Azelon Pharmaceuticals
• IGI
• Shanghai Fudan-Zhangjiang Bio-Pharmaceutical
• Stelis Biopharma
• Asahi Kasei Pharma
• Intas Pharmaceuticals
• Alkermes
• Alkem Laboratories
• Paras Biopharmaceuticals
• Gedeon Richter
• Zydus Cadila
• Mochida Pharmaceutical
• USV

Key Products

• BONSITY
• CinnoPar
• hPTH(1-34)
• Modified PTH
• Movymia
• Osteofortil
• Parathyroid hormone biosimilar
• Recombinant parathyroid hormone biosimilar
• rhPTH (1-34)
• SBL 001
• Teribone
• Terifrac
• Teriparatide AIR
• Terrosa
• IFNα-2b
• PF708