How explosive growth in biosimilars presents new challenges in the clinical trial supply chain


With patent protection for many innovator biological drugs expiring within the next few years, the early 21st century may well be remembered as the dawn of the Biosimilar Era, and for good reason. Biologics are a resounding success story for the biopharmaceutical industry, credited for making possible giant leaps forward in the long-term treatment of diabetes, rheumatoid arthritis, cancers, kidney failure, multiple sclerosis, orphan, and other diseases.

Roughly $79 billion of these biologic products will become susceptible to biosimilar competition by 2020.1 The expiry of patent protection for these medicines is creating a biosimilars market expected to be so lucrative that generic manufacturers, emerging market firms, large pharmaceutical and biotechnology companies, and even businesses with no drug experience whatsoever are competing for a share of it. In fact, so many players are targeting for a slice of the biosimilars market that they are facing off in a fierce development race. This whitepaper provides an overview of the biosimilars market and learn more about the amazing potential of these newly developed medicines and how they are altering the economics of healthcare.