Understanding Biosimilars Value of Biosimilars
QUALITY IS CRITICAL Building Quality Into Biosimilars
QUALITY IS CRITICAL Building Quality Into Biosimilars

In order to make sure that biosimilars are safe, controlling their quality is critical. Quality is a key focus of the biosimilar maker’s efforts. This section explains 3 phases that Merck uses to help create and ensure quality biosimilars.

THE QUALITY OF BIOSIMILARS IS IMPORTANT

The quality of a biosimilar should be built into the way it is made. This is done using specific methods and processes.1-3 Merck looks at these processes as having 3 phases. We call them Create, Confirm, and Control.

CLICK ON A C TO READ MORE ABOUT EACH STAGE
TAP ON A C TO READ MORE ABOUT EACH STAGE
 
 
 
CREATE:
Imagine creating a biosimilar

The first thing to do would be to learn everything about the originator. How is it put together? How does it work in someone's body? Why does it work that way?

Those are the exact questions that the makers of biosimilars have to ask. They study the originator very carefully. Then, when they create the biosimilar, they can check to make sure it’s similar to the originator.1

CONFIRM:
Now, imagine trying to work out if a biosimilar is actually similar to an originator

Does the biosimilar match up to what was learned about the originator biologics? The FDA has said that the makers of biosimilars must show 3 types of proof. They have to show that2,3:

  • Biosimilars are created in a similar way. They have to prove that their biosimilars are put together in a way similar to the originator biologics
  • Biosimilars work in a similar way. They have to prove that their biosimilars act in a similar way to the originator biologics
  • Biosimilars have similar results. They have to prove that their biosimilars can be expected to be as effective and well tolerated in patients

Makers of biosimilars must show all 3 types of proof before the FDA approves the biosimilar.

CONTROL:
Finally, imagine needing to create quality biosimilars batch after batch

That's just what the makers of biosimilars have to do. The makers of biosimilars test a biosimilar over and over while it’s being made. Then they test it again once it’s been made. They do this to help make sure the biosimilar is always high quality, every time. This helps people always get a medicine that is effective and well tolerated.1,2

Quality is critical to biosimilars. The key points to remember are3:

  • The makers of biosimilars study the originator very carefully. This lets them make sure their biosimilars match the originator biologics as closely as possible
  • The makers of biosimilars carry out hundreds of tests to prove the biosimilars they make are similar to the originator biologic
  • Even after they’ve proved they’re similar, the makers of biosimilars keep on testing their biosimilars. This lets them help make sure their biosimilars are well tolerated and effective
References:
1. FDA. Guidance for industry. Q8(R2) Pharmaceutical Development. http://www.fda.gov/downloads/Drugs/.../Guidances/ucm073507.pdf. Published November 2009. Accessed June 3, 2016. 2. US FDA. Quality considerations in demonstrating biosimilarity of a therapeutic protein product to a reference product. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm291134.pdf. Published April 2015. Accessed June 3, 2016. 3. US FDA. Scientific considerations in demonstrating biosimilarity to a reference product. http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/UCM291128.pdf. Published April 2015. Accessed June 3, 2016.