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Biosimilars: what sufferers have to know

  • A biosimilar and its unique biologic are comprised of the identical sorts of sources – and have the identical remedy dangers and advantages.
  • Biosimilars are a sort of biologic remedy that’s protected and efficient for treating many sicknesses.
  • A biosimilar and its unique biologic have the identical remedy dangers and advantages.
  • Biosimilars could also be out there at a decrease price than the unique biologics.

What’s a biosimilar remedy?

A biosimilar is a biologic remedy. It’s extremely much like a biologic remedy already accepted by FDA – the unique biologic (additionally known as the reference product).

Biosimilars additionally don’t have any clinically significant variations from the reference product. This implies you’ll be able to count on the identical security and effectiveness from the biosimilar over the course of remedy as you’d the reference product.

Biosimilars are comprised of the identical sorts of sources (e.g., dwelling cells or microorganisms) and are simply as protected and efficient as their reference merchandise.

What are biologic medicines?

Organic merchandise (additionally known as biologics) will be fabricated from sugars, proteins, dwelling cells, tissues, or a mixture of those. They’re comprised of pure and dwelling sources like animal and plant cells, and microorganisms similar to micro organism or yeast.

Organic medicines are normally extra advanced than different medicine. They’re usually extra sophisticated to purify, course of, and manufacture.

A biosimilar may be very comparable, however not equivalent, to an unique biologic remedy.

For biosimilars to be accepted by FDA, research should present that there are not any variations within the security and effectiveness of biosimilars and the unique biologics.

Each a biosimilar and its unique biologic:

  • Are comprised of the identical sorts of sources (e.g., dwelling sources).
  • Present the identical advantages when treating ailments or medical circumstances.
  • Are given on the identical energy and dosage.
  • Aren’t anticipated to trigger new or worsening unwanted effects.

Is your remedy out there as a biosimilar?

As with all remedy choices, you must speak to your healthcare suppliers and verify different trusted sources of knowledge associated to your particular situation to study extra about biosimilar remedy choices.

Study extra about FDA-approved biosimilar merchandise

Biosimilars are protected and efficient.

They’re used for the remedy of many persistent and extreme circumstances, together with:

FDA makes positive biosimilars are as protected and efficient as the unique product by:

  • Approving biosimilars after a cautious evaluate of information, research, and checks.
  • Monitoring security and effectiveness after approval.
  • Checking for remedy high quality throughout manufacturing.
  • Reviewing affected person security studies made to FDA.

A biosimilar and its unique biologic have the identical remedy dangers and advantages.

In contrast with their unique biologics, biosimilars:

  • Are made with the identical sorts of pure sources.
  • Are given the identical method.
  • Present the identical remedy advantages
  • Have the identical potential unwanted effects.
  • Have the identical energy and dosage.
Biosimilars icon of lower costs

Decrease prices

A affected person may change to a biosimilar due to a change in insurance coverage protection or to economize.

Just like generic medicine, biosimilars could price much less as a result of producers depend on FDA’s discovering that the unique biologics are protected and efficient.

The decrease price will not be a mirrored image of effectiveness or security of biosimilars. Due to the decrease price, biosimilars could also be coated by extra insurance coverage firms and provide sufferers further remedy choices.

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