Summary
Biosimilars are drugs that are highly similar but not identical to branded “innovator” biologics: large molecule, immunogenic drugs produced from living cells. “Innovator” biologics are the first to be approved, and when their patent protection expires, biosimilars may be approved, in a similar way to small molecule branded drugs and their generics.
There are no clinically meaningful differences in quality, safety and efficacy between biosimilars and innovator biologics. The exact definition of a biosimilar varies by regulator.
Biosimilars bring competition to expensive innovator biologics and represent a cost-saving option for payers.
More than 50 biosimilars are approved in the EU, while the FDA lags behind with 17 approvals but is catching up fast. As more innovator biologics come off-patent in the near future, this will bring a huge opportunity for biosimilar companies and for biosimilar manufacturers.
Key Questions Answered
- What biosimilars are marketed in the US and EU?
- How is biosimilar manufacturing and packaging outsourced?
- What therapies are in the biosimilar pipeline?
- In what regions is biosimilar development concentrated?
- How does biosimilar manufacturing differ by molecule type?
- When will innovator biologic patents expire, allowing biosimilar development?
- What proportion of biosimilar manufacturing is kept in-house?
- How will contract analytical testing services be affected by the rise of biosimilars?
Scope
Detailed view of -
- Marketed Innovator Biologics.
- Marketed Biosimilars.
- Innovator Biologic Patent Expiries and Waves of Biosimilar Opportunity.
- Biosimilar Clinical Pipeline.
- Existing CDMO Contracts for Biosimilars for API, Dose and Packaging.
Reasons to buy
- This 74-page report gives important, expert insight you won’t find in any other source. 20 tables and figures throughout the report illustrate major points and trends. This report is required reading for -
- CMO executives who must have deep understanding of the biosimilar marketplace to make strategic planning and investment decisions.
- Sourcing and procurement executives who must understand crucial components of the supply base in order to make decisions about supplier selection and management.
- Pharmaceutical and Biotech companies involved in the development of innovator biologics or biosimilars.
- Investors that need a deeper understanding of the market to identify and value potential investment targets.
Companies Mentioned
AbbVie
Accord Healthcare
Advanced Accelerator Applications
Aeterna Zentaris
Aetos Biologics
Alexion Pharmaceuticals
Allpack
AlphaMab
Amgen
APEIRON Biologics
Apotex
Aptevo Therapeutics
AstraZeneca
Baxter International
Bayer
Bayer Healthcare
Beijing Fogangren Bio-Pharm Tech
Biogen
BioMarin Pharmaceutical
BioReliance
Boehringer Ingelheim BioXcellence
Boehringer Ingelheim
Bristol-Myers Squibb
BTG
Catalent
Celgene
Celltrion
Chiesi Farmaceutici
Chugai Pharmaceutical Co
Clinuvel Pharmaceuticals
Coherus BioSciences
Cook Pharmica
CSL
Dompe Farmaceutici
Eli Lilly
Elusys Therapeutics
Emergent BioSolutions
Endo International
F. Hoffmann-La Roche
Ferring International Center
Finox Biotech
GE Healthcare
Gedeon Richter
Gene Techno Science
Genentech
Genor BioPharma
GlaxoSmithKline
Grunenthal Group
Horizon Pharma
IDT Biologika
Intas Pharmaceuticals
Ipsen
Ironwood Pharmaceuticals
Jazz Pharmaceuticals
Johnson & Johnson
KBI Biopharma
Kyowa Hakko Kirin
La Jolla Pharmaceutical Company
LG Chem
MabPlex International
MannKind Corp
Medac
Medice Arzneimittel Pütter & Co.
MedImmune
Merck & Co / MSD
Merck KGaA
Mustafa Nevzat Pharmaceuticals
Mylan
Novartis
Novartis International
Novelion Therapeutics
Novo Nordisk AS
Octapharma
Ono Pharmaceutical Co
Pall Corp
Patheon
PCI Pharma Services
Pfizer
Pharming Group
Polymun Scientific Immunbiologische Forschung
Portola Pharmaceuticals
Protalix BioTherapeutics
Regeneron Pharmaceuticals
Rentschler Biopharma
rEVO Biologics
Richter Gedeon
Richter-Helm Biologics & Co.
Samsung Bioepis
Samsung BioLogics
Sandoz
Sanofi
ScinoPharm Taiwan
Seattle Genetics
Serenity Pharmaceuticals
Servier
Shanghai Mab Venture Biopharm
ShangPharma Corporation
Shenzen Techdow Pharmaceutical Co.
Shire
Sicor Biotech
SK Chemicals
Spectrum Pharmaceuticals
Stada Arzneimittel
Sun Pharma Advanced Research Company
Swedish Orphan Biovitrum
Synergy Pharmaceuticals
Syngene International
TaiMed Biologics
Teva Pharmaceutical Industries
The Medicines Company
Theratechnologies
ThromboGenics NV
TOLMAR
UCB
Ultragenyx Pharmaceutical
United Therapeutics
Vetter Pharma-Fertigung
Walvax Biotechnology
Wockhardt Contract Manufacturing
WuXi AppTec
Wuxi Biologics
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Table of Contents
1. Executive Summary 4
2. Introduction 6
3. The Biosimilar Opportunity 7
4. Approved Biosimilars 10
5. Market Penetration 29
Regional Variability in Biosimilar Uptake 32
Biosimilar vs. Innovator Market Share 34
New Patient Access 35
6. The Biosimilar Pipeline 36
7. Sourcing Arrangements for Biosimilars 42
Joint Ventures 48
Capacity and scale 52
API Segmentation 52
Geography and Partnerships 53
Analytic and Testing CDMOs 54
8. Notes on Methodology 56
9. Appendix 57
9.1 Bibliography 57
9.2 Primary Research - Key Opinion Leaders in this Report 58
9.3 Additional Tables 59
9.4 About the Authors 75
List of Tables
Table 1: FDA-Approved Biosimilars and Their API Manufacturing Contracts 11
Table 2: FDA-Approved Biosimilars and Their Dose Manufacturing Contracts 13
Table 3: FDA-Approved Biosimilars and Their Packaging Contracts 15
Table 4: EMA-Approved Biosimilars and Their API Manufacturing Contracts 17
Table 5: EMA-Approved Biosimilars and Their Dose Manufacturing Contracts 21
Table 6: EMA-Approved Biosimilars and Their Packaging Contracts 25
Table 7: Waves of Biosimilar Opportunity by EU Patent Expiry of Biologic Innovators 59
Table 8: Waves of Biosimilar Opportunity by US Patent Expiry of Biologic Innovators 67
List of Figures
Figure 1: Waves of Biosimilar Opportunity by EU Patent Expiry of Innovator Biologics 8
Figure 2: Market Share Forecast by Class for UC in the US, 2016 30
Figure 3: Biosimilars in Clinical Development 37
Figure 4: Biosimilar Clinical Development by Sponsor Type 39
Figure 5: Biosimilar Clinical Development by Sponsor HQ Location 40
Figure 6: Outsourcing of Biosimilar Approvals, EU 43
Figure 7: Proportion of API Outsourcing of Biosimilar Approvals, EU, Jan. 2009-Dec. 2018 44
Figure 8: Proportion of Dose Outsourcing of Biosimilar Approvals, EU, Jan. 2009-Dec. 2018 44
Figure 9: Outsourcing of Biosimilar Approvals, US 46
Figure 10: Proportion of API Outsourcing of Biosimilar Approvals, US 46
Figure 11: Proportion of Dose Outsourcing of Biosimilar Approvals, US 47
Figure 12: Manufacturing of FDA- and EMA-Approved Biosimilars by Molecule Type 50
