The BBCIC is a science-based, non-profit, public service initiative that will monitor biosimilars and their corresponding novel biologics for effectiveness and safety. The research will draw on large sets of de-identified medical and pharmacy data covering 100 million people. The BBCIC framework applies the same scientific, analytic methods used by the FDA Sentinel initiative, a post-market surveillance system that harnesses cutting-edge distributed research network and surveillance methods to track the safety of pharmaceuticals and other therapies once they reach the market.
The BBCIC is dedicated to transparency, and findings on products will be made available to providers and patients as they become known.
"We believe our balanced, scientific approach to post-approval pharmacovigilance will answer questions and concerns about biosimilars, leading to greater acceptance and adoption of biosimilars in the U.S. The BBCIC represents an important public health investment and is key to patient and physician confidence," said BBCIC Program Director Bernadette Eichelberger.
What are biosimilars? Biosimilars are less expensive, highly similar, independently developed versions of original biological medicines. Specialty biologics have expanded patient access to safe and effective treatments for some of the most pernicious chronic diseases. By bending the cost curve for specialty drugs, biosimilars offer the opportunity to expand patient assess to biologics. Biosimilars have been available in Europe for the past decade and have expanded patient access to these medications.
A pathway for approving biosimilars in the U.S. was created by the US Biologics Price Competition and Innovation Act (BPCIA) of 2009. The goals for creating the biosimilar pathway for biosimilars in the U.S. were to increase treatment options and reduce health care costs. So far, two biosimilars have entered the U.S. market and others are anticipated to follow. Recent IMS Institute research predicts biosimilars could save up to $110 billion by 2020.
The BBCIC is collaboration of managed care organizations, integrated delivery systems, pharmacy benefit management firms, research institutions and pharmaceutical companies. The BBCIC is the only research network dedicated to monitoring biosimilars. To date the following organizations have made financial and in-kind commitments: AbbVie, Aetna, Amgen, Anthem-Healthcore, Apobiologix, Boehringer Ingelheim Pharmaceuticals, Inc, Express Scripts, Inc., Group Health Cooperative, Harvard Pilgrim Health Care, HealthPartners, Henry Ford Health System, Momenta Pharmaceuticals, Inc., Merck, Optum, Pfizer, and the Hematology Oncology Pharmacy Association. For more information, visit www.BBCIC.org.
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SOURCE Biologics & Biosimilars Collective Intelligence Consortium