This post originally appeared on the blog of Sciformix, a Covance company.
Original Author: Suhasini Sharma Director, Medical Affairs
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.
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 access to breakthrough treatments, it has also created an increasingly competitive environment for finding suitable, experienced sites.
Compounding the issue, physicians are often less interested in supporting biosimilar studies, preferring to engage in clinical trials involving novel targets and compounds or those being conducted by larger academic institutions. Additionally, the level of education and training regarding the established development process for biosimilars is generally low. To overcome these hurdles, Covance has expanded its strategy to help sponsors find qualified sites and investigators willing to provide reliable clinical evidence. Continue reading →
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 clear understanding of key clinical issues and develop a strategy for navigating today’s regulatory environment. Continue reading →
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 understand regulatory differences and identify a fit-for-purpose program. We will also cover how to proactively identify key issues for both PK equivalence and Phase III equivalence studies, and initiate market access and commercialization approaches. Continue reading →
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, stressing the need to understand this rapidly changing landscape. What is the real potential for clinical and health-economic benefits offered by these agents? Continue reading →
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 repeating studies and shorten their development time.
At a recent Covance clinical seminar in Shanghai, attendees learned about the intricacies of 505(b)(2), the corresponding hybrid medicinal product pathway in the European Union and the differences from applications for biosimilars or generics. Developers in the Asia Pacific region are eager to better understand this topic because the Chinese pharmaceutical industry is developing rapidly with support from the government. “They view 505(b)(2) as a potentially faster way to market,” said Eric Lang, MD, Vice President and Global Head of Clinical Drug Development Leaders, Early Phase Development Solutions. To succeed, however, sponsors will need to consult with experts who can help them develop a regulatory strategy and consider market access issues as well. Continue reading →