Drugs

FDA Committee Meeting Raises Biosimilar Issues

The Alliance for Patient Access (AfPA) says that the 7/12-13 hearings of the FDA Arthritis Advisory Committee showed the need for more policy guidance on biosimilars. “Participants and even committee members expressed concerns about unfinished regulatory policy and the need to prioritize patient safety,” the group says in a meeting report.

According to the report, one concern raised was about non-medical switching. AfPA member Madelaine Feldman, a rheumatologist, described patients who were stable on a biologic and then required to switch to a different treatment because of health plans’ financial negotiations. “Physicians can write for any medication they want,” she said. “The insurance company just won’t pay for it.” She urged FDA to halt non-medical switching “until the appropriate switching studies have been performed and the biosimilar meets interchangeability criteria.” Other speakers at the meeting reportedly expressed concerns about forced switching to biosimilars based on cost alone.

The question of post-marketing studies also was raised. University of Pennsylvania School of Medicine professor David Margolis said during the hearing discussion on an etanercept biosimilar that post-marketing studies are necessary to gauge the impact of indication extrapolation and the treatment’s long-term safety. Extrapolation occurs, the report says, when FDA approves a biosimilar to treat a disease state without comprehensive testing for that disease state. Both the impact of biological treatments on patients’ immune systems and the range of conditions that a single biosimilar can be approved to treat necessitate particular caution in extrapolating indications, the report says.

The alliance says that it explained in a letter to FDA before the hearing that the fact that a biosimilar has been tested for some indications of an innovator product is a good indicator of the drug’s safety and efficacy, but should not automatically qualify the biosimilar for additional indications of its reference product.

AfPA says that it and other patient advocacy organizations have urged FDA to include the clinical trials data from the actual biosimilar on the drug’s prescribing information. “FDA has not yet finalized its guidance on prescribing information or on biosimilar naming,” the report concludes.

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