Draft Biosimilar Guidances
On 9 Feb 2012 the FDA published three draft guidance documents on biosimilar product development to assist industry in developing such products in the US.
- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product
The draft guidance is intended to assist companies in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting an application, called a ‘351(k)’ application, to FDA. This draft guidance describes a risk-based ‘totality-of-the-evidence’ approach that FDA intends to use to evaluate the data and information submitted in support of a determination of biosimilarity of the proposed product to the reference product. As outlined in the draft guidance, FDA recommends a stepwise approach in the development of biosimilar products.
- Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product
The draft guidance provides an overview of analytical factors to consider when assessing biosimilarity between a proposed therapeutic protein product and a reference product for the purpose of submitting a 351(k) application. This includes the importance of extensive analytical, physico-chemical and biological characterisation in demonstrating that the proposed biosimilar product is highly similar to the reference product notwithstanding minor differences in clinically inactive components.
- Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
The draft guidance provides answers to common questions from people interested in developing biosimilar products. The question and answer format addresses questions that may arise in the early stages of product development, such as how to request meetings with FDA, addressing differences in formulation from the reference product, how to request exclusivity, and other topics.
Final guidance and quality considerations of April 24, 2017. Q&As: Ref.1 of May 08, 2015, Rev.2 of December 07, 2018.