This “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.
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.
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.
Bonsity: Pfenex
There are approx. 10+ key companies which are developing the therapies for Teriparatide.
The report covers around 10+ products under different phases of clinical development like
The drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
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.
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Teriparatide biosimilar drugs.
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.
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
The 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
The 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 Answered
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
Table of Contents
1. Key Insights2. Teriparatide Biosimilars: Snapshot
3. Executive Summary
3.1. Overview
3.2. The Basics of Biologics.
3.3. Biosimilars are not the Same as Generic Drugs
3.4. Economics of Biosimilars - the Promise of Lower Prices, but at What Cost?
3.5. What Patients Need to Know About Biosimilars
4. Regulatory Outlook For Biosimilars
4.1. North America
4.1.1. US
4.1.2. Canada
4.2. Europe
4.3. Asia Pacific
4.3.1. China
4.3.2. India
4.3.3. Japan
4.3.4. South Korea
4.3.5. Australia
4.4. Rest Of The World
4.4.1. Brazil
4.4.2. Mexico
4.4.3. Argentina
4.4.4. Saudi Arabia
*More Countries would be added in the final report
5. Teriparatide (Reference Product: Forteo)
5.1. Drug Profile
5.2. Product Overview
5.3. Regulatory Approvals and Launch
5.4. Indications
5.5. Mechanism of Action
5.6. Dosage and Administration
5.7. Dosage and Strengths
5.8. Dose Modification
5.9. Route of Synthesis
5.10. Pharmacology
5.11. Pharmacodynamics
5.12. Pharmacokinetics
5.13. Adverse Reactions
5.14. Product Snapshot
5.15. Development Milestones
6. Research and Development
6.1. Clinical Trials Information
6.2. Safety and Efficacy
7. Forteo Biosimilar: Emerging Opportunities
8. Teriparatide: Biosimilars Assessment
8.1. Assessment by Product Type
8.2. Assessment by Route of Administration
8.3. Assessment by Molecule type
8.4. Sales Assessment
9. Teriparatide Biosimilars Profiles: By Company
9.1.1. Pfenex
9.1.1.1. BONSITY: Pfenex
9.1.1.1.1. Product Information
9.1.1.1.2. Research and Development
9.1.1.1.3. Other Development Activities
9.1.1.1.4. General Description Table
9.1.2. Biosidus
9.1.2.1. Osteofortil: Biosidus
9.1.2.1.1. Product Information
9.1.2.1.2. Research and Development
9.1.2.1.3. Other Development Activities
9.1.2.1.4. General Description Table
*More Companies and products would be added in the final report
10. Teriparatide Biosimilars: Comparative Landscape: By Company
11. Teriparatide Biosimilars: Competitive Landscape
11.1.1. Overview
11.1.2. Market Share Analysis
11.1.3. Competitive Scenario
11.1.3.1. Product Launches and approval
11.1.3.2. Partnerships, Collaborations and Agreements
11.1.3.3. Acquisitions
11.1.3.4. Expansions
11.1.3.5. Patent Expiration of Biologics
*More information would be added in the final report
12. Market Drivers
13. Market Barriers
14. SWOT Analysis
15. Appendix
15.1. Research Methodology
15.1.1. Coverage
15.1.2. Secondary Research
16. Bibliography
17. Publisher Capabilities
18. Disclaimer
19. About the PublisherList of Tables
Table 1 Total Products for Teriparatide
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive ProductsList of Figures
Figure 1 Total Products for Teriparatide
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products
Companies Mentioned (Partial List)
A selection of companies mentioned in this report includes, but is not limited to:
- 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
