PRA is poised to help our clients capitalize on opportunities in the rapidly emerging biosimilar space. Our strong background in biologics/monoclonal antibodies affords us a thorough understanding of the challenges and success factors involved in biologic and biosimilar drug development.
PRA’s successful track record of managing trials involving biological drugs (biologics, monoclonal antibodies and biosimilars) spans from early phase development through successful regulatory submission in a number of therapeutic areas. We have supported studies leading to FDA approvals for five biological drug products on the market today:
- Oncology: Avastin®, Sutent®, and Tarceva®
- Hematology: Velcade®
- Immunology: Remicade®
Biological Drug Study Experience
Over the last five years, PRA has been involved in the development of 14 key biological drugs that are either under patent or coming off patent. Our experience includes a number of indications in hematology, oncology, neurology, immunology, infectious diseases, and endocrinology, as shown below.
PRA’s Study Experience in Key Biological Drugs
Biologic and Monoclonal Antibody Study Experience
In the past five years, PRA has managed 164 biologic clinical studies and projects (84 Phase I - IV clinical studies and 80 non-clinical/consulting projects) and 58 monoclonal antibody clinical studies and projects (45 Phase I - IV clinical studies and 13 non-clinical/consulting projects). Our top indications in each of these two areas are depicted below:
PRA’s Approach to Biosimilar Development Programs
Our study experience has afforded us an understanding of the key success factors in this area of clinical research. For example, we have learned that patient recruitment is a compelling challenge in biosimilar drug development. Therefore, PRA has leveraged the expertise of our dedicated, in-house Feasibility team to develop specific recruitment strategies for biosimilar trials.
PRA offers comprehensive, cross-functional support for your biosimilar development programs including:
- Regulatory Affairs monitors the evolving regulatory pathway as it relates to the challenges of drug development in biosimilars, enhancing speed-to-market
- Therapeutic Expertise leads strategic development and international experience as advisory board members, strategic consultants, principal investigators, medical monitors and NDA managers for numerous biosimilar-biologic disease treatments
- Safety and Risk Management helps clients design, implement and operationalize the proper safety procedures from development through to market
- Early Development Services serves as a full-service bioanalytical research partner for pre-clinical and clinical Phase I - IV studies with extensive experience in biologics analysis
PRA Biosimilar Development Support Program