Module 1 2021

25/06/2021

Target Product Profile(s)

Overdosage Description

Indications and Usage Dosage & Administrations Dosage Forms & Strengths Contraindications Warnings & Precautions

Clinical Pharmacology Nonclinical Toxicology Clinical Studies References Info on administration Storage conditions Patient Counseling Info

Adverse Reactions Drug Interactions

Use in Specific Populations Drug Abuse & Dependence

FDA, Guidance of Industry, Target Product Profile www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080593.pdf

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Draft TPP – an example

Key Competitor (Best in Class – Currently on Market)

Features Minimum Requirements Target Requirements (Base Case)

Optimal Requirements

“XY” in adults and children in the US & EU

“XY” in both adults and children

“XY” in adults

Indication

No reported of serious phase/ events

Same as target =>

Significant Reduction of serious phase/ events

Efficacy

Fewer systemic AEs vs. existing IV

Fewer systemic AEs vs. existing IV and/ new route administration…

<= Same as Target

Competitor XY

Safety

Much better local and better systemic tolerability vs. Competitor (<30% patients experiencing local AE)

Better local tolerability vs. Competitor (<70% patients experiencing local AE)

Better local tolerability and systemic tolerability competitor (<50% patients experiencing local AE)

Same as target =>

every other day or weekly dosing.

<= Same as Target

“conventional” dosing

Dosing / Bioavailability

EU: 200% of monthly dose (similar to Competitor). US: 200% of monthly dose

EU: No dose adjustment. US: Less dose adjustment than Competitor

No dose adjustment

Device 1

Same as target =>

Device 1 or Device 2

Conventional administration requiring Devices 1 & 2

Ease of Use / Sizes & Needles

Sizes: 5ml with needle for peds; 10ml with needle for adults Simple Process: normal administration no additional equipment required Special Pack for protection; sterility barrier not required. to be packed in unit carton with PI

Sizes: 5 and 10ml with needle for peds & adults

<= Same as Target

Same as target =>

<= Same as Target

Packaging

Competitor, glass vials (v rious sizes)

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