WASHINGTON – Dr. Richard Dolinar, chairman of the Alliance for Safe Biologic Medicines (ASBM) issued the following statement in response to the Supreme Court ruling on the Affordable Care Act and its impact on the Food and Drug Administration’s (FDA) creation of a biosimilar pathway.
“As biosimilar medicines are introduced into the U.S. in the next few years, ASBM believes patient safety must be the top priority while the FDA creates a pathway for their approval. Because biosimilars are similar to, but not exact copies of the biologic medicines they aim to replicate, it is imperative that patient safety is the cornerstone of the approval process. Unlike traditional pharmaceutical drugs that are made from chemicals, biologics are developed from living cells, large and complex molecular mixtures that are not easily replicated. The smallest differences in the structure or manufacturing process could have serious implications for patients.
“We have supported the initial steps the FDA has taken to create this framework and will continue to encourage the incorporation of a patient-centered, science-based approach, similar to those taken in the European Union and in Canada. We are looking forward to additional opportunities to weigh in with the FDA as it formalizes the biosimilar pathway.”
To speak to Dr. Dolinar or another member of the Alliance for Safe Biologic Medicines, please email media@safebiologics.org.
About the Alliance for Safe Biologic Medicines
The Alliance for Safe Biologic Medicines (ASBM) is an organization composed of diverse healthcare groups and individuals from patients to physicians, innovative medical biotechnology companies, and others who are working together to ensure patient safety is at the forefront of the biosimilars policy discussion. We serve as an authoritative resource center of information for the public, medical communities, the FDA and other state and federal policymakers during the implementation of the biosimilars pathway and beyond. Visit us at www.safebiologics.org.
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