FDA Gives Final Word On Biosimilar ‘Interchangeability’ In Move That Could Boost Competition In Pricey Market
The FDA released guidelines on the studies companies need to conduct to show their biosimilar is interchangeable with a biologic. Right now, biosimilars can’t automatically be substituted by a pharmacy for a brand product without the FDA’s interchangeability designation, and there are no FDA-approved interchangeable biosimilars on the market. Advocates hope this move will change that.
Stat:
FDA Finalizes Rules For When A Biosimilar Is 'Interchangeable' With A Biologic
The FDA on Friday spelled out exactly what kind of studies biosimilar drug makers must conduct in order to be considered “interchangeable” with a biologic drug the way a generic functions for a normal medicine. It’s the agency’s final word on a controversial and long-running fight over how it will define those rules for the pricey category of biologic drugs, the complex drugs made from living organisms used to treat conditions like cancer, and their copycat biosimilars. (Florko and Silverman, 5/10)
Modern Healthcare:
FDA Finalizes Guidance To Spur Biosimilar Availability
The FDA has approved 19 biosimilar drugs, but it has not approved any drugs that are interchangeable with a biologic. Several providers say that the lack of interchangeability has been one of the barriers to more availability with others being physician reluctance. Catholic hospital chain Ascension recently complained at a U.S. House of Representatives hearing that physicians are reluctant to prescribe biosimilars and interchangeability is gravely needed. The guidance will be very helpful for healthcare systems that include pharmacies. (King, 5/10)
In other pharmaceutical news —
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Gilead Will Donate Truvada For HIV Prevention, But Reaction Is Mixed
Seeking to blunt criticism of its pricing, Gilead Sciences (GILD) is donating enough of its HIV prevention pill to cover as many as 200,000 patients over the next 11 years. The donation will cover both the existing Truvada pill, which has been the subject of battles with AIDS activists, and still another drug the company hopes will also win regulatory approval to prevent the virus. The move was hailed by the Trump administration, which announced plans to end HIV in the U.S. by 2030, but has also been criticized by activists for not taking steps to reduce the cost of Truvada. The pill, which is also sometimes referred to as PrEP, costs about $1,675 a month, or $20,000 a year, but has been climbing steadily since it was first introduced in 2004 for treating HIV. (Silverman, 5/10)
