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Overcome hurdles with integrated solutions

To fully realize the commercial potential of biosimilars, you need to effectively address the distinct challenges and pressures involved: constantly evolving regulations, fierce competition, and market access are just a few.  From concept to commercialization, you need a partner with the expertise, resources, and experience to manage the risks and accelerate your biosimilars clinical development.

Quintiles has worked on 52 phase I/III trials in 15 biosimilar compounds since 2011

Determine the best approach

Biosimilars pose very different challenges than those presented by small molecule generics: higher costs and more demanding head to head similarity assessments: analytically, non-clinically and clinically: differences in regulatory framework in different markets can deter global investment; and a need for significant investments in sales and marketing.

Our integrated solutions are designed to meet the distinct demands of bringing biosimilars to market and maximizing their ROI. We partner with all types of customers engaged in producing biologics, bio-betters and biosimilars. Quintiles offers a full range of expertise – scientific, technical, regulatory, clinical, registration and commercialization:

  • biosimilars advise develop commercializeA global Biosimilars Center of Excellence (CoE) to provide thought leadership, guidance, and experience across the globe, including dedicated centers in the US and Asia Pacific
  • Accelerated Phase I/III capabilities with interim safety analysis to shorten timelines
  • An investigator network, Biosimilars Knowledge Connect, with extensive biosimilars resources, including a monthly newsletter, and investigator & patient best practices
  • Extensive biosimilars experience, with over 50 phase I/III trials in various therapeutic areas
  • A streamlined operating model with regional service delivery to minimize costs and support your local needs
  • Comparator access to in-source EU/US reference products into countries of interest
We help increase your potential for success by incorporating commercial and regulatory considerations early in the development process. We share your goals to accelerate launch without sacrificing quality, demonstrate safety and efficacy from initial phases to post-market, and build stakeholder trust.

The power of possibilities

Our dedicated biosimilar intelligence team is ready to provide key regulatory, commercial and clinical insights to help your product realize its full potential.

Related Services

Regulatory Affairs
Clinical Trial Planning & Design
Market Access Strategy