Regulatory approval pathways

It is important to distinguish between biosimilars and noncomparable biologics. Noncomparables (also known as “biocopies,” “biomimics,” “intended copies,” and “nonregulated biologics”) are copies of licensed biologic medicines that are marketed in some countries, but have not followed the rigorous regulatory pathways required for biosimilars.¹ Although noncomparables may contain the same amino acid sequence as the reference product, they have not been subjected to the same strict analytical, nonclinical, and clinical comparative evaluations prior to market approval as biosimilars regulatory pathways mandate.²

As a result, these products may have clinically significant differences in quality, efficacy, and safety compared with their reference products. Certain noncomparables have been shown to have reduced biological potency or higher rates of adverse events, underscoring the importance of following a stringent regulatory pathway for the approval of all biologic medicines.^2-4

The World Health Organization (WHO) has issued a roadmap for member states to review noncomparables with the same stringent regulatory assessments as that of current biosimilars review standards.⁵