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United States Biosimilars Market Outlook to 2025: Clinical Pipeline by Company, Indication & Phase of 28 Biosimilars & 9 Marketed Biosimilars

DUBLIN, May 2, 2019 /PRNewswire/ -- The "US Biosimilars Market, Dosage, Price & Clinical Pipeline Outlook 2025" report has been added to's offering.

"US Biosimilars Market, Dosage, Price & Clinical Pipeline Outlook 2025" report gives comprehensive insight on clinical and non-clinical issues involved in the development of biosimilars market in the US. The report highlights the ongoing market trends and initiatives undertaken by various stakeholders to advance the approval and commercialization of biosimilars in the US pharmaceutical market.

Biosimilars have started gaining attention worldwide as they are cheaper but equally effective than their original product. Biosimilars cost lesser than biologics as they take less time to develop and go through only four stages of testing - analytical, non-clinical, clinical pharmacology and clinical studies. Biosimilars are not similar or the same as generic drugs due to a difference in their physiochemical properties.

Globally they are at different stages of progression with respect to adoption of biosimilars in the mainstream pharmaceutical market. Although the European market is the most mature market in comparison to the US market, it is catching up to speed. Total of 19 biosimilars have been approved by FDA since 2014, but only 9 biosimilars have been able to make it to the market as of 2019. The most recent approved biosimilar is Trazimera of Pfizer (March 11, 2019).

Most successful biosimilar in the US market has been Sandoz's Zarxio. It captured more market than Inflectra. Biosimilars market has a bright future. The market has the potential to grow faster if some of the issues like interchangeability status, extrapolation, shortening exclusivity period, etc. are solved. In addition, market competition needs to be promoted.

Currently, the US biosimilars market is at the interim state. With most of the biologic products going off patent by 2025 and increasing rate of patients suffering from chronic diseases. The biosimilars market has a huge opportunity to spread its wings in the US drug market. With few reforms and education to the stakeholders, this goal is achievable.

The US biosimilar market will continue to evolve and grow exponentially but with a small degree of uncertainty. The regulatory authorities need to form a more concrete framework to keep these grey areas of the biosimilar market in check. This, accompanied by education of physicians/patients to speed market uptake, new development, and commercial paradigms can provide the proper platform for developing new commercially successful biosimilars.

"US Biosimilars Market, Dosage, Price & Clinical Pipeline Outlook 2025" Report Highlights:

  • US Biosimilar Market Current Scenario
  • US Biosimilars Clinical Pipeline by Company, Indication & Phase: 28 Biosimilars
  • Marketed Biosimilars Clinical Insight by Company & Indication: 9 Biosimilars
  • Biosimilars Market Opportunity: US$ 5 Billion
  • FDA Rules & Regulations For Biosimilars Development & Market
  • Approved & Marketed Biosimilars: Clinical Insight, Price & Dosage

Key Topics Covered:

1. Overview Of Biosimilars Market
1.1 History & Evolution Of Biosimilars
1.2 Global Biosimilars Market: Flourishing

2. Engineering Behind Biosimilars
2.1 Designing From Scratch
2.2 Developing Biosimilars
2.2.1 Quality
2.2.2 Nonclinical Evaluation
2.2.3 Clinical Evaluation

3. Working of Biosimilars

4. Technical Innovations In Biosimilars
4.1 Improved Expression Systems
4.2 Higher Titers To Reduce Capacity Requirements
4.3 Analytical Technology
4.4 Quality By Design

5. Biosimilars & Generics: Different Or Same?

6. Budding US Biosimilar Market
6.1 Market Overview
6.2 US Biosimilar Pipeline Overview

7. FDA Rules & Regulations For Biosimilars Development & Market
7.1 Data Required For Approval
7.2 Need For Abbreviated Approval Pathway
7.3 Biosimilar User Fees
7.4 Biosimilars Action Plan

8. Biologics Coming Off Patent by 2025

9. FDA Approved Biosimilars

10. US - Approved & Marketed Biosimilars: Clinical, Price & Dosage
10.1 Retacrit (epoetin alfa-epbx)
10.2 Zarxio (filgrastim-sndz)
10.3 Nivestym (filgrastim-aafi)
10.4 Granix (tbo-filgrastim)
10.5 Inflectra (infliximab-dyyb)
10.6 Renflexis (infliximab-abda)
10.7 Fulphila (pegfilgrastim-jmdb)
10.8 Udenyca (pegfilgrastim-cbqv)

11. US - Approved Not Marketed Biosimilars
11.1 Trazimera (trastuzumab-qyyp)
11.2 Amjevita (adalimumab-atto)
11.3 Cyltezo (adalimumab-adbm)
11.4 Hyrimoz (adalimumab-adaz)
11.5 Mvasi (bevacizumab-awwb)
11.6 Erelzi (etanercept-szzs)
11.7 Ixifi (infliximab-qbtx)
11.8 Truxima (rituximab-abbs)
11.9 Ogivri (trastuzumab-dkst)
11.10 Herzuma (trastuzumab-pkrb)
11.12 Ontruzant (trastuzumab-dttb)

12. Tackling the High Price
12.1 Promote Competition
12.2 Shortening Exclusivity Period
12.3 Interchangeability
12.4 Extrapolation
12.5 Reforms for Cost Effective Drug

13. Payers: Concierge to US Biosimilar Market

14. US Biosimilar Market Dynamics
14.1 Market Drivers
14.2 Hurdles To Cross

15. US Biosimilar Market PEST Analysis

16. US Biosimilar Market Future Prospects

17. US - Biosimilars Clinical Pipeline by Company, Indication & Phase
17.1 Research
17.2 Preclinical
17.3 Clinical
17.4 Phase-I
17.5 Preregistration
17.6 Registered

18. US - Marketed Biosimilars Clinical Insight by Company & Indication
18.1 Adalimumab (Humira & Raheara)
18.2 Insulin Glargine Biosimilar (Abasaglar, Abasria & Basaglar)
18.3 Somatropin Biosimilar (Omnitrope & PrOmnitrope)
18.4 Insulin Lispro Biosimilar (Admelog & Insulin lispro Sanofi)
18.5 Trenonacog Alfa (IXINITY)
18.6 Pegfilgrastim Biosimilar - Biocon/Mylan
18.7 Infliximab Biosimilar (Flixabi & RENFLEXIS)
18.8 Bevacizumab Biosimilar (Mvasi)
18.9 Desvenlafaxine - Extended Release - Alembic

19. Suspended Biosimilars in Clinical Pipeline by Company, Indication & Phase
19.1 No Development Reported
19.2 Discontinued
19.3 Suspended

20. Competitive Landscape
20.1 Alembic
20.2 Allergan
20.3 Aptevo Therapeutics
20.4 Biocon
20.5 Celltrion
20.6 Eli Lilly
20.7 MedImmune
20.8 Pfizer
20.9 Polpharma
20.10 Samsung Bioepis
20.11 Sandoz
20.12 Sanofi
20.13 Teva

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