"Biomimics" Are Not Biosimilars, PANLAR Statement Warns

A consensus statement developed by the Pan American League of Associations for Rheumatology (PANLAR) regarding biosimilars warned against the use of so-called biomimics, or copy biologics.

These products are local copies of approved biologic drugs that received approval without adhering to the international standards for evaluation and approval of biosimilars; the statement said such copies of etanercept and rituximab are available in some Asian and Latin American countries.

If these copies are to be sold, the statement said, they must first be evaluated and approved by a regulatory agency according to guidelines developed by the World Health Organization for new biologics and biosimilars.

The statement was developed through a literature review and a consensus was reached when there was agreement among 80% or more of the panel members. The review included 108 articles, which were classified into the following topics: extrapolation of indications, safety, regulation, interchangeability, pharmacovigilance, immunogenicity, and pharmacoeconomic.

Besides the warning about biomimics, the statement noted the following:

• Biosimiliars should be considered for rheumatological diseases, and to enhance patient access, the price of biosimilars should be significantly lower than that of reference products.
• Pharmacovigilance is a key strategy to ensure safety of after launch, but few countries in Latin America have well-established systems in place, as opposed to their neighbors in the United States and Canada.
• Likewise, much of Latin American does not yet employ risk management plans, as do the northern countries in PANLAR. Registries should be used to monitor use of biosimilars and to identify potential adverse effects, and traceability should be used throughout the supply chain.
• Regulatory agencies should also use a naming convention to distinguish between biosimilars and biologics.

However, no consensus was achieved regarding extrapolation of indications, or about automatic substitution at the pharmacy counter without the permission of the provider.

Among the questions that must be settled, the statement said, are what would be required to designate a drug as interchangeable and how many switches between reference products and biosimilars would be needed in a clinical trial.

Reference

Kowalski, SC, Benavides, JA, Roa, PAB et al. PANLAR Consensus Statement on Biosimilars. Clin Rheumatol. 2019;38(5):1485-1496. doi: 10.1007/s10067-019-04496-3.