Interchangeable Biosimilars Could Be
On Market In 2 Years – FDA

Makers of interchangeable biosimilars could see their drugs approved and on the market within the next two years – maybe even sooner, according to soundings from the US Food and Drug Administration (FDA).

The Regulatory Affairs Professionals Society (RAPS) reported that the FDA’s biosimilars lead, Leah Christl, told delegates at the Drug Information Association’s recent conference in Chicago that interchangeable biosimilars could be available within 24 months or less with their regulatory approval reviewed by an advisory committee comprising external experts.

The US biosimilars market was born in 2010 when the Patient Protection and Affordable Care Act was signed into law by then-president Barack Obama. It established two types of products that are defined as being ‘biosimilar’ or ‘interchangeable’ with an existing drug already licensed by the FDA. A biosimilar is a drug that is “highly similar” to an existing, FDA-approved drug and “has no clinically meaningful differences” to that drug, known as the reference product, in terms of safety and effectiveness.

An interchangeable biosimilar is similar to an existing, FDA-approved drug, meeting “additional standards” for interchangeability and producing the same clinical outcome as its reference product. A key difference between biosimilars and interchangeable biosimilars is that an interchangeable biosimilar can be substituted for its reference product by a pharmacist – without the approval or intervention of the doctor who prescribed it. But so far, few biosimilars have made it to market – there have been only five – and none of them have been interchangeable biosimilars. An example of an approved biosimilar is Samsung Bioepis’ Renflexis, which is a biosimilar to Johnson & Johnson’s Remicade, used to treat auto-immune diseases.

RAPS said that the FDA is reviewing industry feedback on its draft guidance on interchangeable biosimilars, published earlier this year, and will disclose revised or final guidance within the next two years. But there are concerns around how the introduction of interchangeable biosimilars will affect the US drugs market. There are arguments that pharmacists should not be allowed to switch products without a doctor’s notification and a sense that interchangeables are in some way ‘better’ than their non-interchangeable counterparts.

It is expected that the FDA will become more efficient at approving biosimilar drugs, driven by hiring more staff, more meetings with and written responses to drug-makers about their biosimilar applications and the renewal of the biosimilars user fee program, designed to speed-up the review process for biosimilar drugs.

The FDA has said that biosimilars offer an “important public health benefit”, offering essential drugs to patients at a cheaper cost than their brand-name reference products.



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