Biosimilars: A futuristic fast-to-market advice to developers

ABSTRACT

Introduction

Biosimilars are expected to improve the accessibility of biological drugs, a goal that has not been reached because of the high cost of development. This is about to change based on the history of biosimilars’ safety, the regulatory agencies’ flexibility in reducing the testing requirements, and the scientific advances in analytical methods to enable better assessment of biosimilarity.

Areas Covered

Regulatory development plan supporting justification of fewer studies, including a selection criterion for the critical quality attributes, determination of the relevance of testing, and designing intelligent clinical testing protocols to reduce the time to market.

Expert Opinion

The safety and efficacy of biosimilars can be established only based on analytical assessment and clinical pharmacology comparisons. Waivers of animal toxicology and pharmacodynamic studies and clinical efficacy and safety studies will not be required as these studies add little value in supporting the claim of biosimilarity.

KEYWORDS:

• Biosimilars
• animal testing
• clinical efficacy
• biosimilarity
• analytical assessment
• clinical pharmacology
• regulatory plan

Article highlights

• Conclusions drawn from the analysis of the registration dossier of over 100 biosimilars demonstrate that exclusion of animal testing and clinical efficacy testing would not have changed the approval decision.

• Animal testing is now widely discouraged on humanitarian grounds since these studies cannot provide any helpful information for biological drugs.

• Clinical trials are inconclusive because of their modeling deficiencies and sensitivity to detect differences between products.

• Both essential elements of testing, analytical and clinical pharmacology, can be reduced by using better models and population selection criteria.

• While the agencies are ready to accept waivers or reduced submissions requests, the onus lies on the developers, who remain less informed and less prepared.

Declaration of Interests

The author has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

One of the peer reviewers of this manuscript is an author of a Celltrion and Sandoz Biosimilar publication. Two additional peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.