An Efficient Development Paradigm for Biosimilars

Area of Science:

• Biopharmaceutical Science
• Regulatory Science
• Drug Development

Background:

• The current biosimilar development paradigm, known as 'totality of evidence' (ToE), is derived from novel drug development.
• ToE requires extensive analytical, nonclinical, and clinical data, making it burdensome and inefficient.
• This paradigm does not allow for biosimilarity conclusions based on analytical data alone.

Purpose of the Study:

• To propose a new, more efficient paradigm for biosimilar development.
• To introduce the 'confirmation of sufficient likeness' (CSL) approach.
• To maintain scientific rigor while improving efficiency in biosimilar approvals.

Main Methods:

• The proposed CSL paradigm emphasizes analytical resemblance between biosimilar candidates and reference products.
• CSL does not require bridging studies, in vivo nonclinical studies, or powered efficacy studies.
• This approach relies on comprehensive analytical characterization.

Main Results:

• Analysis of past biosimilar approvals shows that candidates highly similar in analytical and pharmacokinetic studies have consistently been approved.
• The CSL approach offers a scientifically rigorous alternative to ToE.
• The proposed CSL paradigm streamlines the development process.

Conclusions:

• The 'confirmation of sufficient likeness' (CSL) paradigm offers a more efficient and sustainable pathway for biosimilar development.
• CSL maintains scientific rigor by focusing on analytical similarity.
• Adopting CSL can enhance the attractiveness and sustainability of biosimilars as a therapeutic option.