ACCELERATING BIOSIMILARS DEVELOPMENT
Around the world, costly biologics are out of reach for many patients. There is a pressing need for effective biosimilar alternatives but bringing products to market can be intense.
As a pioneer in biosimilars development, we understand your challenges and sense of urgency. We have the proven expertise to help you design a sound development plan and regulatory strategy to ensure the successful execution of your biosimilars program.
PPD has supported the development of all top 10 selling biologics and successfully delivered the first monoclonal antibody biosimilar to the European Union market.
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Experienced sites around the world
The Difference Between a Reference Biologic and a Biosimilar Product
Leverage the power of our biosimilar development expertise. We offer a full range of services from cell line development and characterization to clinical experience in diverse disease indications, regulatory knowledge, lab analytics and innovative statistics technology to provide required evidence of biologic equivalency for approval.
Our Services Get Your Biosimilars Approved
You’ll engage directly with our cross-functional and cross-therapeutic team of experts throughout your program. This valuable extension of your team provides the expert insights and comprehensive strategies needed to optimize your plan and protocol. Together, we operationalize best-practice approaches to shorten timelines, while ensuring validation and delivery of the safety and efficacy data required to gain regulatory approval and speed entry of your biosimilar asset to market.
Biosimilar development services include:
- Preclinical development
- Start up
- Global clinical supplies
- Biosimilar investigator network
- Clinical development
- Regulatory affairs
- Pharmacokinetic and pharmacodynamic
- Chemistry, manufacturing and controls support
Experience with all Clinical Phases
Benefit from our 10+ years of biosimilars experience, spanning all clinical trial phases and a broad spectrum of therapeutic areas including immunology, dermatology, hematology, oncology, ophthalmology, metabolic and women’s health for organizations of all sizes.
We’ll help you accelerate and manage timelines across the diverse geographic landscape, providing strategic guidance, regulatory consulting, program consistency and quality of operational delivery.
- Biologics development: 20 years of biologics experience, generating and communicating evidence of effectiveness and efficient delivery to market
- Global footprint: Network of 2,200 top performer sites globally
- Top performance: Our site startup team has a proven track record of expediting site activations and ensuring enrollment for faster biosimilar studies, spanning the entire continuum of development
- Data-driven results: A commitment to forward-looking, innovative technology empowers you with the analytics-driven insights, efficacy and safety data required to gain regulatory approval