Basics of Biopharmaceuticals and Biosimilars

Course Introduction

The Basics of Biopharmaceuticals and Biosimilars course provides foundational knowledge of biologic medicines and their biosimilar counterparts used in modern healthcare. It focuses on understanding how these complex therapies are developed, regulated, and applied in clinical practice. This course supports Terraleap’s mission to deliver up-to-date, industry-relevant education for healthcare and life-science learners.


Scope of the Course

This course covers core concepts of biopharmaceuticals, including biologic drug classification, manufacturing principles, mechanisms of action, and therapeutic applications. It also introduces biosimilars, highlighting comparability, regulatory pathways, safety, efficacy, and pharmacovigilance considerations.


Course Objectives

By the end of this course, learners will be able to:

  • Understand the fundamentals of biopharmaceuticals and biosimilars

  • Differentiate between biologics, biosimilars, and conventional drugs

  • Explain basic development and regulatory principles

  • Recognize clinical and safety considerations of biologic therapies

  • Appreciate the role of biosimilars in healthcare systems


Course Outcomes

After completing the course, learners will be able to:

  • Demonstrate foundational knowledge of biologic medicines

  • Understand the clinical relevance of biosimilars

  • Support informed use of biopharmaceuticals in healthcare settings

  • Communicate basic concepts related to biologics and biosimilars

  • Apply knowledge in academic, clinical, or industry contexts


Who Can Enroll

This course is suitable for:

  • Pharmacists and pharmacy technicians

  • Medical, nursing, and allied health professionals

  • Life sciences and biotechnology students

  • MedTech and healthcare industry professionals

  • Individuals seeking introductory knowledge in biopharmaceuticals

Syllabus & format
Basics of Biopharmaceuticals and Biosimilars

   Overview of Biopharmaceuticals and Biosimilars
   Biopharmaceutical Development and Production
   Regulatory Framework in India for Biopharmaceuticals and Biosimilars
   Development and Approval Process of Biosimilars
   Intellectual Property Patents and Market Access for Biosimilars in India
   Pharmacovigilance and Post Marketing Surveillance in Biopharmaceuticals and Biosimilars
   Future Trends and Innovations in Biopharmaceuticals and Biosimilars