Biosimilars in dermatology: identifying myths and knowledge gaps

Area of Science:

• Pharmacokinetics and biosimilarity assessment.

Background:

• Biosimilars are nearing regulatory approval in the US, requiring structural and functional similarity to innovator biologics.
• Biologics exhibit inherent batch-to-batch variability, making exact duplication impossible even for the innovator.

Purpose of the Study:

• To propose a biosimilarity index for standardizing preclinical definitions of biosimilarity.
• To enhance trust and transparency in biosimilar assessment through a quantitative, standardized approach.

Main Methods:

• Review of current biosimilarity assessment standards.
• Proposal of a biosimilarity index by the International Psoriasis Council.
• Emphasis on preclinical analyses and post-approval monitoring.

Main Results:

• A biosimilarity index, combined with post-approval monitoring, can offer a transparent, quantitative definition of biosimilarity.
• This approach can increase confidence in biosimilar medicines without escalating costs.

Conclusions:

• Manufacturers should prioritize robust preclinical analyses for biosimilar approval.
• Dermatologists may need to focus more on preclinical data alongside clinical evidence.
• Biosimilars often demonstrate greater similarity than innovator product batches, suggesting consistent standards are crucial.