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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.
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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.
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Key Players:
• 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
Purchase this report online with 74 Pages, List of Tables & Figures and in-depth Table of Contents on “Global Biosimilars Market”@ https://www.orbisresearch.com/contact/purchase/2435941
Key Points from TOC:
1. Executive Summary 4
2. Introduction 6
3. The Biosimilar Opportunity 7
4. Approved Biosimilars 10
5. Market Penetration 29
6. The Biosimilar Pipeline 36
7. Sourcing Arrangements for Biosimilars 42
8. Notes on Methodology 56
9. Appendix 57
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