PharmSource – Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars – 2018 Edition
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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.
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 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
The report will enable you to:
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
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
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Frequently asked questions
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