School of Pharma Sciences (Cross-School) · Career Track

Biosimilar Development Specialist

A senior-level track (9-12 months) preparing you for biosimilar development roles, covering advanced analytical comparability, quality assurance for tech transfer, global regulatory pathways, and market access strategies. Completing the track earns the Biosimilars Certificate.

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Duration

9–12 months

Courses

8 Courses

Certificate

Biosimilars Certificate

School

School of Pharma Sciences (Cross-School)

TRACK LEARNING PATH

Your Course Roadmap

BSM-101

Biosimilar R&D – Reverse Engineering the Originator

BSM-102

Manufacturing Strategies for Biosimilarity Match

QA-101

GMP Fundamentals and Regulatory Requirements

BSM-201

Advanced Analytical Comparability & Characterization

BSM-202

Quality Assurance for Biosimilar Tech Transfer

BUS-201

Advanced Portfolio Strategy

BSM-301

Global Regulatory Pathways for Biosimilars (351(k) & EMA)

BSM-302

Market Access, Pricing & Interchangeability Strategies

8 courses in sequence · leading to the Biosimilars Certificate

CERTIFICATE EARNED

Certificate: Biosimilars Certificate

Duration

9–12 months

Credits

8 Courses

Tuition Band

$3,500–$4,500

Awarded By

School of Pharma Sciences (Cross-School)

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CURRICULUM DOMAINS

Domains Covered in This Track

WHAT YOU WILL MASTER

Skills You Will Gain

Originator reverse engineering Analytical comparability Biosimilar manufacturing strategy Tech transfer quality assurance 351(k) & EMA regulatory pathways Interchangeability strategy Pricing & market access

LEARNING OUTCOMES

By the End of This Track, You Can…

01Reverse-engineer originator molecules into biosimilar target profiles

02Design analytical comparability exercises that satisfy 351(k) and EMA reviewers

03Plan manufacturing for biosimilarity match and tech transfer

04Navigate global biosimilar regulatory pathways

05Build interchangeability and market-access strategies

Ready to Become a Biosimilar Development Specialist?

Your track. Your courses. Your certificate. UTB makes the path clear — from day one.

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