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Biosimilar Consulting

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 attracting increased 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 cost 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 set of issues for biopharmaceutical companies, regulatory agencies, healthcare providers, and patients around the world.  Although follow-on proteins have already reached 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 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.

Key Materials

Establishing US Approvals for Biosimilars

Learn how the key guidance and regulatory pathways were presented to the FDA as they considered biosimilars in the US. Download here.

Indian Biosimilars Guidelines

Learn how India's new guidelines may represent a step towards universal acceptance of a scientifically sound global biosimilars development program. Download here.

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Early Phase Services

More of What You Need for a Stronger Start in Phase I. Your journey from new molecule to new medicine starts with appropriate subjects, world class facilities, and more timely results. PAREXEL® provides comprehensive early phase testing services through our own hospital-based clinical units on three continents.

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Clinical trials constitute the single most expensive component of the entire drug development process. In particular, clinical trial operations represent one of the most resource-intensive areas within a biopharmaceutical company and often involve tedious, manual processes for collecting, aggregating and rationalizing information from a wide variety of data sources.

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Clinical Outcome Assessments / ePRO

Clinical Outcome Assessments (COAs) measure a patient’s symptoms, overall mental state, or the effects of a disease or condition on how the patient functions. COAs can be used to determine whether or not a drug has been demonstrated to provide treatment benefit. COA types include ePRO (electronic Patient Reported Outcomes).

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Strategic Compliance & Risk Management

Our trusted experts, including renowned former regulators, know how to institute proactive compliance and have a strong track record of helping companies get out of regulatory crises. They are well versed in biopharmaceutical, medical device / diagnostic regulations and ICH guidance, and are focused on the success of your products and company.

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Integrated Product Development

Journeys, of course, have varied destinations. But whether you’re taking a new molecule to market, exploring how to differentiate a current product, or evaluating new geographic options, PAREXEL®’s Integrated Product Development team can shorten your product’s time to market and provide the strategic bandwidth and marketplace resources to help that product achieve more commercially.

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HERON™ Commercialization

In this post-blockbuster era, traditional opportunities for sustained growth throughout your products’ long-term journey are limited. Biologics, biomarkers, genomics, personalized medicine, and proteomics offer promising alternatives, but commercial dynamics of the biopharmaceutical industry are uncertain.

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