Infographic: Challenges and Solutions in Developing Biosimilars

Biosimilars are biological medicines that are extremely similar to already approved biopharmaceutical drugs (originator or reference medicinal product (RMP)). Biosimilars can be manufactured when the original product’s patent expires. Importantly, biosimilars, unlike small-molecule generics, are not classified as a generic of the RMP due to natural variability and the complex manufacturing process of biological medicines which do not allow for an exact replication of molecular heterogeneity.


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  • Global market trends and opportunities for the biosimilars industry
  • Comparability studies and the role they play in biosimilar development
  • How Sartorius’ cutting-edge technologies can help overcome challenges when developing biosimilars

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