With analytical methodologies and reference data being the foundation of
successful biosimilar development, we develop and optimize product specific
methods to increase confidence in our analytical results. Starting with a formal risk
assessment of each potential Product Quality Attribute (PQS), we develop product release
and stability methodologies to evaluate both product quality and safety.
As patent expiry timelines shorten, we continue our analytical data collection by fully
characterizing the reference product methodologies, fully exploring the mechanism(s) of action
of the product, and detailing the reference product higher order structures.
Program | PQS | ASP |
---|---|---|
Humira® | ||
Dupixent® | ||
Keytruda® | ||
Cosentyx® | ||
Ocrevus® | ||
Darzalex® | ||
Entyvio® | ||
Simponi® | ||
Stelara® | ||
Nucala® | ||
Opdivo® | ||
Herceptin® | ||
Rituxan® | ||
Avastin® | ||
Remicade® | ||
Actemra® | ||
Perjeta® | ||
Prolia/Xgeva® | ||
Tecentriq® | ||
Tysabri® | ||
Tremfya® | ||
Yervoy® | ||
Imfinzi® | ||
Skyrizi® | ||
Fasenra® | ||
Repatha® | ||
Taltz® | ||
Ultomiris® | ||
Hemlibra® | ||
Enbrel® |
Entirety of the PQS, additionally includes:
1280 N. Mathilda Ave
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United States
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partner@similis.bio
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