Research Report On: PharmSource-Catching the Next Wave How Much Have C | Page 2

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.
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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: