The Evolution of Biologics and Biosimilars

Biopharmaceuticals have seen significant advances in recent years, particularly with the development of biologics and biosimilars. These innovative therapies have revolutionised the treatment landscape for various diseases, offering targeted and personalised approaches.

Currently, 80% of the top-selling pharmaceuticals are biologics and, as the demand for these therapies continues to rise, the development of biosimilars has had a significant positive impact on costs for clinical trials, helping to bring safe and effective drugs to market at an affordable price.

Understanding Biologics and Biosimilars

Biologics are therapeutic agents derived from living organisms such as humans, animals or microorganisms. They are large, complex molecules that include proteins, antibodies and nucleic acids.

Biologics are the new standard of care and have opened new avenues for the treatment of conditions such as cancer, auto-immune disorders and genetic diseases, offering enhanced efficacy and reduced side-effects in comparison to traditional small molecule drugs.

Biologics are protected by patents, which grant exclusive rights to the originator company for a specific period. This exclusivity allows the originator company to charge premium prices for their products, which has a significant impact on the cost of clinical trials. However, when patents expire, biosimilar manufacturers can enter the market, leading to increased competition and potential price reductions for clinical trials.

Biosimilars are highly similar versions of approved biologics (referred to as ‘reference medicines’ or ‘originator medicines’) and are designed to be comparable in terms of structure, quality, safety and efficacy. These follow-on versions offer an opportunity to provide more affordable alternatives to costly biologics, expanding patient access to life-changing therapies.

CSI’s Sourcing Expertise

CSI specialises in sourcing biologics and biosimilars and has supplied them to more than 700 oncology studies around the world:

Biologic	Number of Studies	Phase of Trial	Geography
Pembrolizumab	50+	1, 2, 3	Europe, USA
Aflibercept	50+	1, 2, 3	Europe, USA, Latin America
Nivolumab​	50+	1, 2, 3	Global
Ipilimumab	50+	1, 2, 3	Global

Biologics and biosimilars that CSI has successfully supplied to studies globally:

• Adalimumab

• Cetuximab

• Daratumumab

• Adalimumab

• Adalimumab

• Trastuzumab

• Bevacizumab

• Infliximab

• Ustekinumab

• Rituximab

• Filgrastim

• Pegfilgrastim

While increased complexity, regulatory requirements, manufacturing challenges and intellectual property considerations have all contributed to the rising cost of biologics, the emergence of biosimilars has introduced competition and attendant price reductions.

As the field continues to evolve, it is crucial to strike a balance between the need for innovation and affordability to ensure the continued development and accessibility of these groundbreaking therapies.

Read more about what to consider when purchasing biosimilar products and further information about CSI’s sourcing capabilities.

Read more about biosimilars in clinical trials and key regulatory considerations.

Learn more about CSI's expertise in biosimilar supply