University of Tampa Bay (UTB) — Pharmaceutical Education Reimagined · Est. February 2026
University of Tampa Bay University of Tampa Bay4i · Industry Integrated
Specialized Modalities

Biosimilar Development Specialist

Current Position: Biologics scientist or engineer moving into biosimilar development

Duration
9–12 months
Cost
$3,500–$4,500
Certificate
Biosimilars Certificate
Level
Mid–Senior

The Biosimilar Development Specialist Path

As a Biosimilar Development Specialist, you own the science of sameness — reverse engineering originator biologics, designing analytical comparability exercises, and navigating 351(k) and EMA regulatory pathways. This UTB learning path is mapped specifically to the skills this role demands — combining hands-on technical training with the regulatory and business knowledge employers expect. Complete the recommended courses to earn the Biosimilars Certificate and position yourself for your next career move.

🎯
Career Outcome
Next Step: Biosimilar Program Director or Portfolio Lead

Your Course Roadmap

01
BSM-101
Biosimilar R&D – Reverse Engineering the Originator
02
BSM-102
Manufacturing Strategies for Biosimilarity Match
03
QA-101
GMP Fundamentals and Regulatory Requirements
04
BSM-201
Advanced Analytical Comparability & Characterization
05
BSM-202
Quality Assurance for Biosimilar Tech Transfer
06
BUS-201
Advanced Portfolio Strategy
07
BSM-301
Global Regulatory Pathways for Biosimilars (351(k) & EMA)
08
BSM-302
Market Access, Pricing & Interchangeability Strategies

8 recommended courses · leading to the Biosimilars Certificate

CERTIFICATE EARNED

Biosimilars Certificate

Duration
9–12 months
Cost
$3,500–$4,500
Credits
8 Courses
Enroll in This Path →

This Path Is Delivered Through the Biosimilar Development Specialist Track

Your Career Progression

Current Role
Biologics scientist or engineer moving into biosimilar development
→
This Program
Biosimilars Certificate
→
Career Outcome
Biosimilar Program Director or Portfolio Lead

Ready to Become a Biosimilar Development Specialist?

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

Enroll Now → View All Roles