biosimilars Archives - Insights From Our Labs to Yours

A Creative Solution to Address the Biosimilar Boom

by Labcorpupdated on Monday, July 26, 2021Monday, June 7, 2021

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 …

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

by Mark Fletcher and Martin Knightupdated on Monday, June 7, 2021Monday, February 17, 2020

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

by Labcorpupdated on Tuesday, June 2, 2020Friday, August 17, 2018

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.

Rheumatoid Arthritis Biosimilars: Regulatory and Clinical Considerations

by Alicia M. Bakerupdated on Wednesday, May 19, 2021Tuesday, June 6, 2017

Three biosimilars for rheumatoid arthritis (RA) were approved by the FDA last year, but the regulatory pathway in the U.S. is still considered a new frontier, especially when compared to regulatory guidance in the EU. With our global industry’s growing interest in developing biosimilars, it’s critical that sponsors have a …

Covance Contract Research Org Biosimilars Webinar 2

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

by Labcorpupdated on Monday, July 26, 2021Wednesday, May 10, 2017

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 …

The Biosimilars Landscape: What All Developers Need to Know

by Labcorpupdated on Wednesday, May 19, 2021Thursday, March 16, 2017

As biosimilars to treat rheumatic diseases begin get approval from the FDA, biosimilar development remains a hot topic in drug development. Sponsors estimate a 35% growth of biosimilars in their development pipelines by 2020, but face a wide variety of regional and global markets along with shifting guidelines and recommendations, …

505(b)(2): An Abbreviated Pathway for Modified Drugs Covance Blog

Understanding 505(b)(2): An Abbreviated Pathway for Modified Drugs

by Labcorpupdated on Wednesday, May 19, 2021Wednesday, July 6, 2016

Among the regulatory pathways for small molecule drugs in the United States, the 505(b)(2) option occupies a middle ground. Intended for modifications of an existing treatment, it requires much more evidence than a generic but allows the sponsor to use data from a previous application. Companies can thus avoid unnecessarily …