Biosimilar oversight? Advocacy groups lobby Congress to increase patient safety

02-Feb-2018 - Last updated on 02-Feb-2018 at 14:37 GMT

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Patient advocacy groups have called on Congress to address patient safety concerns in oversight hearings, following an influx of US FDA biosimilar drug approvals.

National coalition group Patients for Biologics Safety & Access (PBSA) requested the US Senate Committee on Health, Education, Labor and Pensions and the US House Committee on Energy and Commerce convene “to assure that patient safety and access are being fully protected.”

PBSA represents patient advocacy organisations including the American Autoimmune Related Diseases Association (AARDA), Immune Deficiency Foundation (IDF), and Hepatitis Foundation International.

US Congress approved the reauthorisation of the Biosimilar User Fee Act (BsUFA) last year, but PBSA said it has not held an oversight hearing on biosimilars since 2016.

In the request, the PBSA urged the US Food and Drug Administration (FDA) take additional steps to protect patients from insurance practices, such as non-medical switching (NMS).

NMS is the switching of a patient’s medicine for reasons other than the patient’s health and safety – for example to increase private insurer profits, or reduce government agency costs.

The Group also requested the FDA evaluate post-marketing surveillance activities to ensure biosimilars are tracked for adverse events.

Further, it called on the Administration to educate patients and physicians on the introduction of biosimilars into the US market, including the Biologics Price Competition and Innovation Act.

“Millions of Americans who rely on biologics and biosimilars to manage their health depend on the safety and effectiveness of these drugs to live a healthy, stable life,” said Immune Deficiency Foundaton’s Larry LaMotte.

“As more biosimilars come to market, it is critical that Congress ensure that the FDA is prioritizing patient safety through its guidance, approvals, education and post-market surveillance,” he added.

PBSA said if accepted, the oversight hearings would be timely, given the noticeable increase of biosimilar approvals in the US.

There are currently nine approved biosimilars stateside, five of which entered the market in 2017.

2017 approvals include Samsung Bioepis and Merck’s Renflexis (infliximab-abda), Boehringer-Ingelheim’s Cyltezo (adalimumab-adbm), Amgen and Allergan’s Mvasi (bevacizumab-awwb), Mylan and Biocon’s Ogivri (trastuzumab-dkst), and Pfizer’s Ixifi (infliximab-qbtx).