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Regulation of Follow-On Biologics: Ensuring Quality and Patient Safety

An impressive group of experts from the fields of medicine, science, economics, and health policy discuss the quality and safety issues involved in creating a regulatory pathway to bring follow-on biologics, or biosimilars, to market in the United States. Several of the forum speakers participated in a follow-up congressional briefing in November 2009.The discussions provide various perspectives and valuable insights to spur positive action toward assuring that the dual goals of lower costs and patient safety can be met. Speakers include Michael McCaughan, The Pink Sheet; Brian Harvey,MD, PhD, sanofi-aventis; Gundu H.R. Rao, MD, Lillehei Heart Institute; Ann Witt, JD, U. S. Food and Drug Administration; Geno Merli, MD, Thomas Jefferson University Hospital; Judith K. Jones, MD, PhD, Degge Group; Terry Hisey, Deloitte; Laurence Kotlikoff, PhD, Boston University, Randy Vogenberg, RPh, PhD, EPS and Biologic Finance and Access Council.

This supplement is based on a policy forum held at the National Press Club in Washington, D. C., in April 2009, and sponsored by the Jefferson School of Population Health in Philadelphia.

Phase 3 Clinical Trials Support STELARA® (ustekinumab) for the Treatment of Moderate to Severe Plaque Psoriasis

STELARA® is a subcutaneously administered biologic approved by the US Food and Drug Administration in September 2009 for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. This Clinical Brief summarizes the 2 phase 3 multicenter, randomized, double-blind, placebo-controlled trials that demonstrated the efficacy and safety of STELARA®.

The Impact of Molecular Diagnostics on Treatment Pathways, Outcomes, and Cost

Adjuvant chemotherapy can improve survival in patients with early-stage breast cancer or colorectal cancer who have undergone surgical resection, but the benefit from this treatment is not universal. A distinguished panel of experts addresses the advance in molecular diagnostic testing and its impact on optimal care for cancer patients. David M. Hyams, MD, FACS, presents the epidemiology of breast and colorectal cancers and discusses treatment options and how molecular diagnostics can be used to better manage patients. Cari Bruins, PharmD, focuses on the impact of molecular diagnostics on health outcomes and cost in quality-of-care initiatives. Winston Wong, PharmD, shows the value of incorporating genomic testing into oncology treatment pathways.

Highlights:

  • Clinical Advances in Treatment Options and Diagnostics to Manage Breast cancer and Colon cancer
  • Impact of Molecular Diagnostics on Health Outcomes and Cost
  • Role of Molecular Diagnostics in Quality of Care Initiatives

The Ongoing Evolution of Endpoints in Oncology

Since the U.S. Food and Drug Administration’s 1992 adoption of accelerated drug approval regulation, manufacturers often have turned to surrogate endpoints to speed the market arrival of new agents with the potential to save or extend lives. Despite its “gold standard” status, overall survival is increasingly regarded as a flawed measure of efficacy in colorectal cancer and advanced breast cancer. Surrogate endpoints can speed the time necessary to bring new anticancer agents to market, though each surrogate has its advantages and disadvantages.

Albert Tzeel, MD, MHSA, FACPE, Market Medical Officer for Humana Inc’s Great Lakes Region, discusses the importance of understanding surrogate endpoints for managed care decision makers.