US Food And Drug Administration Issues Equivalence Guideline For Biosimilars Producers

By Catherine Saez

Biotherapeutic medicines are made out of living organisms and cannot be replicated. No generic medicines, which are exact copies of the reference product, can be made. The generic equivalent of a biotherapeutic would be biosimilars, which are highly similar products. The United States Food and Drug Administration has issued a guide to help producers to prove how close their biosimilars are to the biotherapeutics.

In December, the FDA issued guidance [pdf] for industry on Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. The document underlines the critical role of clinical pharmacology studies in the development of biosimilar products.

According to the US Public Health Service Act, ” Biosimilarity is defined at section 351(i)(2) of the PHS Act to mean that the biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components and that there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.”

Finnegan, Henderson, Farabow, Garrett & Dunner LLP published a summary of the guidance, and said the guidance is part of the FDA’s efforts to implement the 2009 Biologics Price Competition and Innovation Act.

According to the law firm, the guidance also “provides a list of critical topics that the biosimilar applicant should discuss with the FDA in designing their clinical pharmacology development program,” including study design, use of non-licensed comparator products, study populations, dose selections, routes of administration, and statistical comparisons of results.