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ASBM Statement on Automatic Substitution

Friday, October 26th, 2012

The Patient Protection and Affordable Care Act passed by Congress and signed into law by President Obama in March 2010, contained a provision establishing an abbreviated pathway for the approval of biosimilars (also referred to as followon biologics, or subsequent entry biologics) in the U.S.

In February 2012, the U.S. Food and Drug Administration (FDA) released a set of three draft guidance documents on biosimilar product development to assist industry in developing such products in the U.S. The guidance documents outlined the FDA’s current thinking on key scientific and regulatory factors involved in submitting applications for biosimilar products to the agency but did not provide any insight on how the agency would handle, “interchangeable biosimilars.” In fact, the regulatory agency sent an unambiguous signal on this topic when it stated in the draft guidance “[t]his document is not intended to provide an overview of FDA’s approach to determining interchangeability because FDA is continuing to consider the type of information sufficient to enable FDA to determine that a biological product is interchangeable.”

On May 24, 2012 ASBM Chairman Richard Dolinar, M.D., convened a working group of Advisory Board members to discuss the elements of a physician notification policy for interchangeable biosimilars that prioritizes patient safety and protects the relationship between physicians and their patients but also respects the sovereignty of pharmacists as healthcare providers. As ASBM continues to work with stakeholders to develop an official position statement on this very important topic there are a few key principles that ASBM believes must be reflected in any policy recommendation:

(1) Physicians have the authority to specify “do not substitute” for biological products and that specification overrides any policy – e.g. by payers or state law – that would have substitution be the standard or default practice;

(2) Physicians and pharmacists should work collaboratively to ensure that the treating physician is aware of the exact biologic – by manufacturer – given to a patient in order to facilitate patient care and accurate attribution of any adverse events that may occurs; and

(3) The timing of the notification process must not impose an undue burden on the pharmacist and need not be in advance of a substitution being made but must be timely enough to facilitate accurate record keeping and attribution of adverse events by the physician.