Understanding the challenges of biosimilars
"Biosimilar" is the term that is used to describe medicines that are the equivalent of generic drugs, but for protein-based, biologic therapies. Also known as "follow-on" proteins, biosimilars are drawing increasing interest from both generic manufacturers and research-based biopharmaceutical companies as larger numbers of biological products reach the market and, in turn, lose their patent protection. Given the high price of most current biologic therapies, many companies see significant opportunities to market more-affordable biosimilars that would make biologic treatments available to much greater numbers of patients.
At the same time, biosimilar products present a complex web of issues for biopharmaceutical companies, regulatory agencies, healthcare providers, and patients around the world. Although follow-on proteins have already reached the market in Europe and parts of Asia, important issues about how to define biosimilars, and how their safety and efficacy should be demonstrated, have yet to be fully resolved. Some of the key questions surrounding these products, which are discussed in the following pages of this section, include:
- How "similar" to the original biologics do biosimilar products need to be? Must they be manufactured in an identical way, or are variations permissible?
- How much clinical data should be required to demonstrate equivalence?
- Can the biosimilar concept be applied to more complex proteins, such as monoclonal antibodies?
- Can biosimilar products be created for a global market based on a single development program?
With the many uncertainties surrounding the development of biosimilars, it is vital for potential biosimilar manufacturers to access experienced medical, clinical, and regulatory expertise to help support and guide their decision-making. PAREXEL is a recognized global leader in biosimilar development, with a wide range of expert resources in this rapidly growing field. We understand the scientific and business challenges you face, based on our experience conducting biosimilar trials involving more than 3,500 patients. We can also draw on the unparalleled expertise at PAREXEL Consulting, based on more than 100 consulting and clinical projects for follow-on proteins.
For more information about how PAREXEL can help you build your biosimilar development program, follow the links above, or contact us by email at info@parexel.com.
