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Biosimilars Development in the US: Top Pharma Considerations
What is a Biosimilar?
Biosimilars differ from generics in that the biosimilar is not and cannot be an identical reproduction of the respective reference product. Biosimilars also differ in that they:
- Are biological products
- Have a higher molecular weight (100-1000x times larger)
- Have a more sophisticated physiochemical form
Potential Tools to Measure Variability:
- Mass Spectrometry
- Nuclear Magnetic Resonance
- Size Exclusion Chromatography
WHICH CANDIDATE WILL YOU SELECT?
Candidate selection is first driven by the patent expiration date of the reference biologic.
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WHICH APPROVAL PATHWAY WOULD YOU CHOOSE?
The US regulatory framework currently offers four ways to bring a biosimilar to market.
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WILL YOU CHOOSE THE 351(k) PATHWAY?
Anticipated difference in time spent in Phase I to Phase III development:
WILL YOU PARTNER?
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WHEN WILL YOU PARTNER?
In analyzing 76 U.S. biosimilars, partnering events occurred at the following stages of development:
-Strong incentive to partner early
-Early partnerships suggest that companies are confident in approval
-Late partnerships may be costly
::Insert Deal Event Phase (US Biosimilars) Pie Chart
Footer: At the bottom of the report please add a footer with the BioMedTracker logo and add the website URL http://www.BioMedTracker.com under the logo. To the right of the logo add text that says: "Learn more about the current environment for biosimilars in the U.S." "Download BioMedTracker's new Biosimilars Special Report at: goo.gl/3Y1L7u