Biosimilars
Many patients worldwide find costly biologics beyond their reach, creating a growing need for effective and potentially less expensive biosimilar alternatives. The journey to market for these products can be challenging—and finding the right partner that can support the entire process and the appropriate study population for your trials is key.
Why Trialmed for biosimilars clinical trials?
At Trialmed, we have an incomparable depth and breadth of experience and knowledge in biosimilar development. We understand the challenges and urgency you face and know how to support your entire biosimilar program – this includes biologic production, early consulting, program development, bioanalytical support, regulatory support and clinical conduct. Our global reach and model for delivering sites and patients enables you to advance your clinical trial, while our operational approach keeps your progress on time and on budget. Paired with our proven expertise to enroll the participants you need to achieve success, we enable you to tackle the challenges of biosimilar development head on.
Other key Trialmed differentiators include:
Regulatory submission
We can take your ideas for biosimilar development to your regulatory submission for approval.
Broad medical indications
In the last five years we’ve supported 57 biosimilar trials (Phase 1, 3 & registry studies) involving 2,200 sites and in excess of 12,000 patients. These studies have supported a broad array of medical indications and are in addition to the routine support of novel and innovative biologics.
Biosimilar Assay Expertise
Our labs have experienced capabilities to support Pharmacokinetic (PK) assays, anti-drug antibody (ADA) assays, cell-based and LBA neutralizing antibody (NAb) assays, and biomarker (PD) assays. We’ve regularly supported bioequivalence, bioavailability and biocomparability studies with more than 20 biosimilar programs leading to FDA/EMA submissions. We’ve been audited for biosimilar work and have met the stringent Brazilian standards for ANVISA regulatory compliance. We’ve developed assays and tested more than 300,000 samples across more than 16 biosimilars. Our regular sustainable throughput exceeds 10,000 PK samples per month (across multiple studies)
Trialmed experience.
60+ protocols
19,000+ potential patients in database
3,500+ sites supported