We’ve contributed to the pivotal or supportive trials and key new drug application (NDA) support services that led to the regulatory approval of 16 biologic drugs.

Summary

Our collaborative, cross-functional team develops tailored, cost-effective services to meet the unique needs of biosimilars clinical development. We understand the science of comparability and stay up-to-date with today’s evolving regulatory landscape. This allows us to minimize bioanalytical and recruitment challenges and facilitate time to market after patent expiration while delivering safe, cost-effective medicines to the people who need them most.

From chemistry and manufacturing controls (CMS) to licensing, we support our partners throughout the life cycle of their trial. Our comprehensive services include consultation, regulatory, early development services, bioanalytical services, study conduct, safety, and license application, and our global study coordinating centers cover more than 60 countries.

Patients
10,000+

Healthy Volunteers
2,260+

Research Sites
1,700+

Biosimilar Trials
35+

Leveraging our biological experience to enhance our biosimilar studies.

Our successful record of managing biological drug trials speaks for itself—we’ve conducted 288 trials, of which 54 were in monoclonal antibodies, at more than 15,000 global sites with more than 61,000 patients. With our support, 16 biological drug products received FDA approval and are on the market today. This experience enhances our understanding of biosimilars and the unique challenges they present.

The Value of Biobetters by Hazel Gorham, PhD

Ensuring high-quality data while meeting today’s complex regulatory landscape.

Stringent regulatory requirements guide the development of biosimilar medicines and ensure the highest standard of quality, non-clinical, and clinical comparability data. Because the type and extent of data needed vary depending on the complexity of the molecule, as well as the availability of an accepted surrogate endpoint, and the seriousness of safety concerns seen with the reference product or substance class, we develop our biosimilars data packages on a case-by-case basis.

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Accelerating patient recruitment to save you time and money.

Patient recruitment consumes approximately 30% of the clinical timeline and often leads to trial delays. In addition to the standard clinical trial recruitment challenges, biosimilar trials are also facing competition against new biological molecules for the same disease area, changes in standard of care, and a lack of incentives for investigators and patients.

By investing in the education of both investigators and patients, we better facilitate patient recruitment. Our educational materials are tailored to both and highlight the potential value of biosimilars as affordable alternatives to specialty medications. We also leverage our in-house expertise to identify sites with the greatest unmet need for biosimilars as well as the greatest potential for recruitment.

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