1. Overview Of Biosimilars Market

  1.1 History and 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 and Generics : Different Or Same?

6. Budding US Biosimilar Market

  6.1 Market Overview

  6.2 US Biosimilar Pipeline Overview

7. FDA Rules and Regulations For Biosimilars Development and 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  and Marketed Biosimilars: Clinical, Price and 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 and 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 and Indication

  18.1 Adalimumab (Humira and Raheara)

  18.2 Insulin Glargine Biosimilar (Abasaglar, Abasria and Basaglar)

  18.3 Somatropin Biosimilar (Omnitrope and PrOmnitrope)

  18.4 Insulin Lispro Biosimilar (Admelog and Insulin lispro Sanofi)

  18.5 Trenonacog Alfa (IXINITY)

  18.6 Pegfilgrastim Biosimilar - Biocon/Mylan

  18.7 Infliximab Biosimilar (Flixabi and RENFLEXIS)

  18.8 Bevacizumab Biosimilar (Mvasi)

  18.9 Desvenlafaxine - Extended Release - Alembic

19. Suspended Biosimilars in Clinical Pipeline by Company, Indication and Phase

  19.1 No Development Reported

  19.2 Discontinued

  19.3 Suspended

20. Competitve 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

Figure 1-1: Geographic Division Of Biosimilar Market

Figure 1-2: Global - Biosimilars Market Share (%), 2018

Figure 2-1: Sources Of Variation Between Biosimilar Productions

Figure 2-2: Phases Of Biosimilar Development

Figure 2-3: Stages Of Comparability Exercise

Figure 2-4: New Drug Development: Cost and Time Comparison

Figure 3-1: Working Of Biosimilar On Active Rheumatoid Arthritis

Figure 4-1: Technology Needed For Cost Effectiveness Of Biosimilars

Figure 6-1: US - Filgrastim Market Share (%), 2018

Figure 6-2: US - Infliximab Market Share (%), 2018

Figure 6-3: US - Biosimilar Clinical Pipeline By Phase (%), 2019 till 2025

Figure 6-4: US - Biosimilar Clinical Pipeline By Phase (Number), 2019 till 2025

Figure 6-5: US - Biosimilar Discontinued in Clinical Pipeline By Phase (%),2019 till 2025

Figure 6-6: US - Biosimilar Discontinued  in Clinical Pipeline By Phase (Number), 2019 till 2025

Figure 10-1: FDA Approved Biosimilars: Marketed

Figure 10-2: US - Cost Of 10 ml Retacrit In Different Concentration (US$), March'2019

Figure 10-3: US - Price Comparison In Different Concentration Of Zarxio and Neupogen (US$)

Figure 10-4: US - Cost Of Zarxio In Concentration - 300mgc/0.5 ml and 480mgc/0.8 ml (US$)

Figure 10-5: Wholesale Acquisition Cost Of Zarxio, Neupogen and Nivestym - 480mcg/ 0.8 ml (US$)

Figure 10-6: US - Cost Of Nivestym In Different Concentration (300mcg/0.5ml, 480mgc/0.8ml) (US$)

Figure 10-7: US - Cost Of 300 mcg Syringe and Vial Of Granix (US$)

Figure 10-8: US - Cost Of 480 mcg Syringe and Vial Of Granix (US$)

Figure 10-9: US - Cost Of Inflectra and Remicade For Injection dyyb 100 mg Powder (US$)

Figure 10-10: Global - Sale Of Inflectra and Remicade In 2017 (US$ Billions)

Figure 10-11: US - Sale Of Inflectra and Remicade In 2018 (US$ Billions)

Figure 10-12: US - Cost Difference Between Renflexis and Remicade (US$)

Figure 10-13: US - Cost Difference Between Renflexis and Inflectra (US$)

Figure 10-14: US - US - WAC Of Udenyca and Neulasta (US$)

Figure 10-15: US - WAC Of Udenyca and Neulasta (US$)

Figure 10-16: US - Cost Difference Between Udenyca, Fulphila, Neulasta For 6mg/0.6mL (US$)

Figure 11-1: US - Market Share Of Amjevita and Humira By 2032 (%)

Figure 11-2: US - WAC of Mvasi and Avastin (US$)

Figure 13-1: US - Prescription Drug Expenditure By Out of Pocket and Health Insurance (US$ Million), 2018 - 2025

Figure 13-2: US - Prescription Drug Expenditure By Out of Pocket and Health Insurance (US$ Million), 2018

Figure 13-3: US - Prescription Drug Expenditure By Out of Pocket and Health Insurance (%), 2018

Figure 13-4: US - Prescription Drug Expenditure By Out of Pocket and Health Insurance (US$ Million), 2025

Figure 13-5: US - Prescription Drug Expenditure By Out of Pocket and Health Insurance (%), 2025

Figure 13-6: Payers Strategies On Handling Biosimilars.

Figure 13-7: US - Health Care Expenditure By Out of Pocket and Health Insurance (US$ Million), 2018

Figure 13-8: US - Health Care Expenditure By Out of Pocket and Health Insurance (%), 2018

Figure 13-9: US - Health Care Expenditure By Out of Pocket and Health Insurance (US$ Million), 2025

Figure 13-10: US - Health Care Expenditure By Out of Pocket and Health Insurance (US$ Million), 2025

Figure 14-1: Main Therapeutics Areas Of Biosimilar Development (%), 2016

Figure 14-2: US - Share of generic and innovator products in small molecule and large molecule market (%)

Figure 15-1:PEST Analysis Of The Biosimilar Market

Figure 16-1: US - Biosimilar Market Opportunity(US$ Billion), 2019 - 2025

Figure 16-2: Global - GDP Expenditure On Healthcare (%), 2017

Figure 16-3: US - Savings by Biosimilar Molecule Class

Table 5-1: Difference Between Generics and Biosimilars

Table 8-1: US - Coming Off Patent Biologicals: Humanized Antibody

Table 8-2: US - Coming Off Patent Biologicals: Not Humanized Antibody

Table 8-3: US - Coming Off Patent Biologicals: Not Antibodies

Table 9-1: List Of All The FDA Approved Biosimilars

Table 10-1: US - Recommended Dosing of Retacrit For Patients With Chronic Kidney Disease (CKD)

Table 10-2: US - Recommended Dosing Of Retacrit For Zidovudine-Treated Patients With HIV Infection

Table 10-3: US - Recommended Dosing Of Retacrit For Patients Undergoing Cancer Chemotherapy

Table 10-4: US - Recommended Dosing Of Retacrit For Patients   Undergoing   Elective, Non-Cardiac, Non-Vascular Surgery

Table 10-5: US - Recommended Dosage Of Zarxio For Cancer Patients Receiving Myelosuppressive Chemotherapy Or Induction and/or Consolidation Chemotherapy For AML

Table 10-6: US - Recommended Dosage Of Zarxio For Cancer Patients Undergoing Bone Marrow Transplantation

Table 10-7: US - Recommended Dosage Of Zarxio For Cancer Patients Undergoing Autologous PBPC Collection and Therapy

Table 10-8: US - Recommended Dosage Of Zarxio For Patients With Severe Chronic Neutropenia

Table 10-9: US - Recommended Dosage Of Nivestym For Cancer Patients Receiving Myelosuppressive Chemotherapy Or Induction and/Or Consolidation Chemotherapy For AML

Table 10-10: US - Recommended Dosage Of Nivestym For Cancer Patients Undergoing Bone Marrow Transplantation

Table 10-11: US - Recommended Dosage Of Nivestym For Cancer Patients Undergoing Autologous PBPC Collection and Therapy

Table 10-12: US - Recommended Dosage Of Nivestym For Patients and Severe Chronic Neutropenia

Table 10-13: Indications For Inflectra

Table 10-14: US - Recommended dosage Of Inflectra For Different Indications

Table 10-15: Indications of Renflexis

Table 10-16: US - Recommended Dosage Of Renflexis In Different Diseases

Table 10-17: US - Recommended Dosage of Fulphila For Different Indications

Table 10-18: US - Recommended Dosage of Udenyca For Different Indications

Table 11-1: US - Recommended Dosage Of Trazimera For Different Indications

Table 11-2: Indications of Amjevita

Table 11-3: US - Recommended Dosage Of Amjevita For Different Indications

Table 11-4: Indications of Cyltezo

Table 11-5: --US - Recommended Dosage Of Cyltezo For Different Indications

Table 11-6: Indications of Hyrimoz

Table 11-7: US - Recommended Dosage Of Hyrimoz For Different Indications

Table 11-8: Indications of Mvasi

Table 11-9: US - Recommended Dosage Of Mvasi For Different Indications

Table 11-10: US - Recommended Dosage Of Erelzi For Different Indications

Table 11-11: Indications of Ixifi

Table 11-12: US - Recommended Dosage Of Ixifi For Different Indications

Table 11-13: US - Recommended Dosage Of Ogivri For Different Indications

Table 11-14: US - Recommended Dosage Of Herzuma For Different Indications

Table 11-15: US - Recommended Dosage Of Ontruzant For Different Indications