Biosimilars
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, biosimilar clinical research consulting and all aspects of clinical development to market access, commercial consulting and branding.
Working with our biosimilar team 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
As a biosimilar CRO, 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:
- Biosimilar Clinical Trials
- 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 Real World Evidence (RWE)
- Drug Development Experience With Biologics
The next wave of Biosimilars for Immuno-Oncology Biologics will be extremely competitive.
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