For a long time, the cure for diabetes type 1 and type 2 has relied on agonizing insulin shots for patients or insulin infusion via mechanical pumps. Regarding this, experts have been creating artificial pancreatic beta cells with the he…
PharmSource - Catching the Next Wave: How Much Have CMOs Benefited from Biosimilars - 2018 Edition
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?
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.