CRED 8 Presentations

03/07/2024

Strategic Considerations

Line Extension/Hybrid

• Presents a clear change to the referenced product • Additional development work compliments existing data • Ability to refer to originator data (higher bar for 3 rd pty)

Critical Success Factors

• New Market for either originator (or 3 pty) • New Indications (higher bar)

Market Segment

• PIP is required (certain Line extensions…not for Hybrid) • Scientific Advice is usually encouraged • In addition reference data, could also include published data

Regulatory

Timelines

• 1.5 – 2yrs for MA

• Full dossier required • CMC plus own studies to bridge new presentation • Or, CMC plus published data (‘mixed data application)

Development Work

• Often used by originator companies to ‘extend’ Market Exclusivity and Brand renewal (i.e. new and improved) • Unmet medical need? Significant benefit?

Misc.

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Strategic Considerations

Biosimilar

• This is NOT a generic development program • Product which may be ‘Substitutable and Interchangeable’

Critical Success Factors

• Clear pathway for BS in each market • Considering more convenient product?

Market Segment

• PIP is NOT required • Scientific Advice is usually advisable (e.g. MAbs)

Regulatory

Timelines

• 1.5 – 2yrs for MA

• CMC (usually first point to address, ensure comprehensive characterisation) • Relevant safety and efficacy studies

Development Work

Misc.

• Consider the use of relevant analytical techniques…might need to ensure sufficient comparability studies are performed

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