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Keeping pace with rapid change

Today’s biosimilar market is a lot different than yesterday’s.

Biosimilar development programs must align with the very latest requirements in both developed and emerging markets across the globe.

It means adapting to operational challenges in a difficult patient recruitment environment.

And increasingly, it means that multiple competitors are focused on the same reference products – elevating the importance of speed to market, differentiating your brand and adding value for healthcare providers, patients and payers.

We take a holistic view

Our Biosimilar Consortium brings together a cross-functional team of subject matter
experts from across the clinical to commercial spectrum – from regulatory consulting and
all aspects of clinical development to market access, commercial consulting and branding.

Working with our Biosimilar Consortium means you’ll be partnering with a multifaceted
team providing holistic support, with market access and commercialization considerations factored in from the beginning.

Wide experience, tailored to your needs

We’ve supported more than 50 biosimilar clinical development programs – each of them presenting their own opportunities and challenges.

Our experience in biosimilars spans a range of molecules including simple protein drugs, enzymes up to the latest immuno oncology antibodies, and indications such as autoimmune diseases, cancer, ophthalmology and endocrine disorders.

Our capabilities
at a glance:

Clinical Development Plans

Regulatory Consulting

Bioanalytical Services

Phase I Pharmacokinetic
Studies in Healthy Volunteers

Cost Efficient and Lean Phase III Clinical Comparability Studies

Market Access Strategies and RealWorld Evidence

Drug Development Experience
With Biologics

The next wave of Biosimilars for Immuno-Oncology Biologics will be extremely competitive.

Interested in Syneos Health?