RA Biosimilar Recruitment

Is a different recruitment strategy required to enroll RA biosimilar studies? How to succeed despite increasing volume of RA biosimilar development programs

Introduction Although a range of regulatory definitions exist, a biosimilar drug is generally defined as \a biological compound that is highly similar to the reference drug, with no clinically meaningful differences in safety, purity and potency.1,2 In addition, biosimilars can be characterized as reducing healthcare costs while maintaining clinical efficacy …

Pharmacovigilance & risk management for biosimilars: unique challenges & possible solutions

Biological medicines (biologics) have made substantial contributions to the treatment of many chronic and serious diseases such as cancers, chronic inflammatory diseases and some rare genetic disorders, and are expected to provide significant therapeutic benefits to many patients who would otherwise have had limited treatment options.

Biosimilars Covance

A Creative Solution to Address the Biosimilar Boom

Identifying viable study sites presents a challenge in many clinical trials. Biosimilar development is especially challenging as the number of sponsors preparing to broaden access to today’s blockbuster biologics, by providing lower-cost biosimilar alternative, continues to grow. While this flood of research activity will make a significant improvement for patient …

Covance Contract Research Org Biosimilars Webinar 2

A Holistic View of the Biosimilars Landscape: Key Factors for Clinical and Commercial Success

Biosimilars have dominated the headlines in the U.S. with several FDA approvals, legal battles and questions around reimbursement, placing an increased focus on how to successfully navigate this relatively new pathway from end to end. Starting with the regulatory environment to CMC bioanalytics and pharmacodynamics, learn how drug developers can …