FDA hears from stakeholders about biosimilar product development

Pharmacists need additional guidance on the handling of biosimilar products in the pharmacy when these products become more widely available following the approval of the biosimilar pathway.

Those were the comments of Marcie Bough, senior director of government affairs, American Pharmacists Association, who spoke last week to FDA during a public hearing (www.fda.gov/Drugs/NewsEvents/ucm265628.htm) requesting comments about the recently issued draft guidances relating to the development of biosimilar products. Dozens of stakeholders also issued short statements during the one-day meeting.

“The pharmacists processing prescription orders in any pharmacy need a unique prescription by name for a biosimilar and for a biosimilar determined to be interchangeable with a reference product,” said Bough.

“Do we need an individual prescription for the biologic, the biosimilar, and the interchangeable, and does that constitute a unique individual prescription order for each processing of that prescription?” she continued.

Biosimilars are versions of previously developed biologic drugs, but regulators and others caution they cannot be termed “generic,” because they are never precisely the same as the reference product.

Bough also stressed that there will most certainly be a learning curve before, during, and after biosimilars come to market, and more education will be needed on the handling, prescribing, and dispensing logistics for these products.

A number of consumer advocacy groups and others expressed their belief that biosimilars should not be allowed onto the market without clinical trials and that interchangeability of the products with the reference products without the physician’s knowledge should not be allowed.

On the other hand, Everett Neville, chief trade relations officer for Express Scripts, a major pharmacy benefit manager, said that Congress’ rationale in mandating the abbreviated approval pathway was to save money; he maintained that there is well-known science for determining drugs that are highly analytically similar, and that there should not have to be frequent use of clinical trials for approvals of biosimilar products.

The docket for comments will be open under May 25 at www.regulations.gov.