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
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
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
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
14. US Biosimilar Market Dynamics
14.1 Market Drivers
14.2 Hurdles To Cross
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
List of Figures
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 & 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$), March'2019
Figure 10-3: US - Price Comparison In Different Concentration Of Zarxio & Neupogen (US$)
Figure 10-4: US - Cost Of Zarxio In Concentration – 300mgc/0.5 ml & 480mgc/0.8 ml (US$)
Figure 10-5: Wholesale Acquisition Cost Of Zarxio, Neupogen & Nivestym - 480mcg/ 0.8 ml (US$)
Figure 10-6: US - Cost Of Nivestym In Different Concentration (300mcg/0.5ml, 480mgc/0.8ml) (US$)
Figure 10-7: US - Cost Of 300 mcg Syringe & Vial Of Granix (US$)
Figure 10-8: US - Cost Of 480 mcg Syringe & Vial Of Granix (US$)
Figure 10-9: US - Cost Of Inflectra-dyyb & Remicade-dyyb For Injection 100 mg Powder (US$)
Figure 10-10: Global - Sale Of Inflectra & Remicade In 2017 (US$ Billions)
Figure 10-11: US - Sale Of Inflectra & Remicade In 2018 (US$ Billions)
Figure 10-12: US - Cost Difference Between Renflexis & Remicade (US$)
Figure 10-13: US - Cost Difference Between Renflexis & Inflectra (US$)
Figure 10-14: US - US - WAC Of Udenyca & Neulasta (US$)
Figure 10-15: US - WAC Of Udenyca & Neulasta (US$)
Figure 10-16: US - Cost Difference Between Udenyca, Fulphila, Neulasta For 6mg/0.6mL (US$)
Figure 11-1: US – Market Share Of Amjevita & Humira By 2032 (%)
Figure 11-2: US - WAC of Mvasi & Avastin (US$)
Figure 13-1: US - Prescription Drug Expenditure By Out of Pocket & Health Insurance (US$ Million), 2018 - 2025
Figure 13-2: US - Prescription Drug Expenditure By Out of Pocket & Health Insurance (US$ Million), 2018
Figure 13-3: US - Prescription Drug Expenditure By Out of Pocket & Health Insurance (%), 2018
Figure 13-4: US - Prescription Drug Expenditure By Out of Pocket & Health Insurance (US$ Million), 2025
Figure 13-5: US - Prescription Drug Expenditure By Out of Pocket & Health Insurance (%), 2025
Figure 13-6: Payers Strategies On Handling Biosimilars.
Figure 13-7: US - Health Care Expenditure By Out of Pocket & Health Insurance (US$ Million), 2018
Figure 13-8: US - Health Care Expenditure By Out of Pocket & Health Insurance (%), 2018
Figure 13-9: US - Health Care Expenditure By Out of Pocket & Health Insurance (US$ Million), 2025
Figure 13-10: US - Health Care Expenditure By Out of Pocket & 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
List of Tables
Table 5-1: Difference Between Generics & 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 &/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 & 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 &/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 & Therapy
Table 10-12: US – Recommended Dosage Of Nivestym For Patients & 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
