PharmSource – Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars – 2018 Edition
List Price: US $4,995
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?
- To describe and evaluate the biosimilar market opportunity for CDMOs and CMOs
- To describe the network of CDMOs that currently manufacture for the biosimilar market
- To assess the outlook for buyers and sellers of contract manufacturing services for biosimilars, including factors influencing client decisions about whether to manufacture in-house or outsource
Detailed view from the GlobalData Pharma Intelligence Center Drugs Database and Regulatory Milestones Tracker Database:
- marketed innovator biologics
- marketed biosimilars
- innovator biologic patent expiries and waves of biosimilar opportunity
- biosimilar clinical pipeline
Detailed view from the GlobalData PharmSource Contract Service Providers database:
- existing CDMO contracts for biosimilars for API, dose and packaging
Reasons to buy
This 77-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.
Advanced Accelerator Applications
Beijing Fogangren Bio-Pharm Tech
Boehringer Ingelheim BioXcellence
Chugai Pharmaceutical Co
F. Hoffmann-La Roche
Ferring International Center
Gene Techno Science
Johnson & Johnson
Kyowa Hakko Kirin
La Jolla Pharmaceutical Company
Medice Arzneimittel Pütter & Co.
Merck & Co / MSD
Mustafa Nevzat Pharmaceuticals
Novo Nordisk AS
Ono Pharmaceutical Co
PCI Pharma Services
Polymun Scientific Immunbiologische Forschung
Richter-Helm Biologics & Co.
Shanghai Mab Venture Biopharm
Shenzen Techdow Pharmaceutical Co.
Sun Pharma Advanced Research Company
Swedish Orphan Biovitrum
Teva Pharmaceutical Industries
The Medicines Company
Wockhardt Contract Manufacturing