Biosimilars

Overcome hurdles with integrated solutions

To fully realize the commercial potential of biosimilars, you need a partner who can effectively address the distinct challenges they pose in clinical development, market access, manufacturing, and sales and marketing. Quintiles has the broad range of expertise and flexible strategies to manage risks and optimize development.

banner_red testtubes

More than 135 products gained market access

Quintiles has helped gain market access for more than 135 products in the US since 2003.

Determine the best approach

Biosimilars pose very different challenges than those presented by small molecule generics: higher costs and more demanding requirements in clinical development; a fledgling or nonexistent regulatory framework in markets outside of Europe that can deter global investment; and a need for significant investments in sales and marketing.

Experience, strategies and full-spectrum expertise

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 – critical to development. 

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
Podcast Oct 11, 2011
Listen now