United States Biosimilars Market, Dosage, Price & Clinical Pipeline Outlook 2025 – ResearchAndMarkets.com

Biosimilars Market, Dosage, Price & Clinical Pipeline Outlook 2025”

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“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

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
  • Marketed Biosimilars Clinical Insight by Company & Indication: 9
  • 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 &

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 &

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 &

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

For more information about this report visit https://www.researchandmarkets.com/r/8ipa64


Laura Wood, Senior Press Manager
[email protected]
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Topics: Biosimilars
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