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The approval pathway for biosimilars allows sponsors to leverage FDA's finding of safety and effectivenss for the reference product to support approval of the biosimilar at a potentially lower cost to sponsors than the dvelopment program for the originator reference product, provided the sponsor can demonstrate that the biosimilar meets the statutory standards for biosimilar approval. When it comes to the development of a biosimilar, some clinical studies may remain necessary because current analytical technologies, in most cases, may not be sufficient alone to demonstrate that a product meets the standards for biosimilar approval. Still, the reduced need for mltiple large clinical outcomes studies as a part of biosimilar product development can significantly lower development costs. This could result in significantly lower prices for patients and payors. While the U.S. market for biosimilars is still maturing, FDA research suggests that after market entry, biosimilars have the potential to offer significant savings. FDA

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The BAP (Biosimilar Action Plan) is focused on four key areas: (1) improving the efficiency of the biosimilar and interchangeable product development and approval process; (2) maximizing scientific and regulatory clarity for the biosimilar product development community; (3) developing effective communications to improve understanding of biosimilars among patients, clinicians, and payors; and (4) supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay competition.

Hi, what is "payor" here? Can I consider it as investers or sponsors in biosimliars?

If not, what does it mean? When I searched for payor, dictionaries say payer, but still I have no idea what it exactly means. What does the payor pay for?

  • It's a relatively new usage that barely existed a century ago. I searched for the payer/payor is entitled there, to restrict matches to more formal business / legal contexts, but with more "everyday" contexts such as the payer / payer wants [something], the non-standard form doesn't even occur often enough to chart. Avoid it. – FumbleFingers Jul 22 '18 at 16:00
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A payor in accounting and commerce is a person who, or a company which, makes a payment. Sometimes spelled 'payer'. From the context you quoted, it seems that payment for health products such as drugs and medicines is being discussed.

Payor

  • Thanks. So here payor means customers for the drugs? – Mango Gummy Jul 22 '18 at 14:45
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    Whoever is paying for the drugs. Could be the patient who needs the drugs or else the patient's health insurance company or government healthcare scheme provider. – Michael Harvey Jul 22 '18 at 14:59

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