Potential of Biosimilars Assessing Biosimilarity
QUALITY ASSURANCE Quality Assurance Is Critical for Biologics
QUALITY ASSURANCE Quality Assurance Is Critical for Biologics

Properties of biologics, such as higher order structure and posttranslational modifications, are sensitive to changes in the manufacturing process.1,2

  • Even minor structural differences can affect the safety and efficacy of a biologic product2
  • Enhanced approaches to pharmaceutical development, along with quality systems and processes, are integral to the consistent manufacturing of high-quality biosimilars3
THE QUALITY OF BIOSIMILARS IS BUILT IN BY DESIGN

Quality of biosimilars should be built in by design using a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product understanding and process control.4

OUR APPROACH TO DEVELOPING QUALITY BIOSIMILARS INCLUDES 3 PHASES:

Merck and Samsung Bioepis envision the biosimilar development process as having 3 phases, which we call 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 BIOSIMILARS:
Focus on quality standards for pharmaceutical development set by regulatory authorities

The first step is to identify a target product profile, including key physiologic, biologic, and clinical attributes of the originator that the biosimilar must match.3,4

CONFIRM BIOSIMILARITY:
Focus on rigorous regulatory processes required for approval of biosimilars

Biosimilarity is established by the Food and Drug Administration (FDA) through a stepwise series of analytical, animal, and clinical studies.2

CONTROL THE MANUFACTURING PROCESS:
Focus on consistent manufacturing quality

Comparisons of relevant quality attributes are conducted across all manufacturing lots with characterization tests, process controls, and FDA-approved release specifications.3

References:
1. Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann Oncol. 2008;19:411–419. 2. 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. 3. 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. 4. US FDA. Guidance for industry. Q8(R2) Pharmaceutical Development. http://www.fda.gov/downloads/Drugs/.../Guidances/ucm073507.pdf. Published November 2009. Accessed June 3, 2016.