The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) is pleased to announce the addition of a new participating organization, Apobiologix.
Alexandria, Va., Jan. 25, 2017 — The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) is pleased to announce the addition of a new participating organization, Apobiologix. The organization supports the BBCIC’s mission to monitor biosimilars and their corresponding novel biologics for effectiveness and safety.
“We’re in a new era with complex products entering the market, including biologic proteins, gene therapies, cell-based therapies and biosimilars, and ensuring the quality, value and safety of this new category of treatments is of utmost importance,” said Steven Lydeamore, President, Apobiologix. “The burgeoning field of biosimilars in particular requires a collaborative approach to research and education, and we are grateful to be part of the BBCIC’s efforts.”
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.