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Biologics and biosimilars

For more information on Amgen and biosimilars, visit: www.amgen.com/science/amgen_biosimilars

An overview

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Biologics and biosimilars

An overview

Contents

An introduction to biotechnology ................................................................................ 3
Abrief history of medicine development ................................................................................... 4 What are biologic medicines? ................................................................................................... 5 How are biologic medicines developed? ................................................................................... 6 The value ofbiotechnology ....................................................................................................... 8 What are biosimilar medicines? .............................................................................................. 10 How do biosimilars differ from the original innovator medicines? .......................................... 11 The emerging role of biosimilars............................................................................................ 12

Regulating biosimilars ...................................................................................................... 13
Approval pathways for biologic and biosimilar medicines ...................................................... 14 Biosimilar regulations............................................................................................................. 18

Pharmacovigilance and traceability ......................................................................... 21
Naming, tracking and tracing medicines ................................................................................. 22

Substitution and interchangeability......................................................................... 25
The variation in global substitution guidelines ....................................................................... 26

Manufacturing biologics ................................................................................................. 31
The manufacturing process is unique to every manufacturer .................................................. 34 Striving toensure a consistent supply..................................................................................... 35

Glossary ................................................................................................................................... 37
Works cited ............................................................................................................................. 43© 2012

Amgen Inc. All rights reserved. 12-12

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An introduction to biotechnology

An introduction to biotechnology

An introduction to biotechnology

Amgen was one of the first companies to recognize the potential of modern biotechnology in developing valuable medicines for patients – and to assemble the diverse set of skills necessary to advance from hard to appliedscience. A leader in biotechnology since 1980, Amgen is focused on serving patients by discovering, developing and manufacturing innovative human therapeutics. By pioneering the development of novel products based on advances in cellular and molecular biology, Amgen’s therapeutics have changed the practice of medicine and helped millions of people around the world to fight cancer, kidney disease,rheumatoid arthritis and other serious illnesses.

An introduction to biotechnology

The term biotechnology was first coined in 1919 to describe the interaction between biology and human technology for the conversion of raw materials into socially valuable products. At the time, the focus was on food production but by the 1940s early advances in the technology had led to the development of...