As the FDA issued draft guidance on biosimilar product development, a new report finds the global market for biosimilars is forecast to reach $4.8 billion by the year 2015.
In the report “Biosimilars: A Global Strategic Business Report,” market research firm Global Industry Analysts (GIA) says the key factors driving market growth include patent expiries of key biological drugs, cost containment measures from governments, the aging population and supporting legislations.
“Biosimilars” is a term used to describe officially-approved subsequent versions of innovator biopharmaceutical products produced by a different manufacturer after patent expiry. Biological products are therapies used to treat diseases and health conditions. They include a wide variety of products such as vaccines, blood and blood components, gene therapies, tissues and proteins.
Unlike most prescription drugs, which are made through chemical processes, biological products generally are made from human and/or animal materials.
Last week, the FDA issued draft guidance on biosimilar product development to assist the industry in developing such products in the United States.
“When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at every step of the process,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research in a statement. “These draft documents are designed to help industry develop biosimilar versions of currently approved biological products, which can enhance competition and may lead to better patient access and lower cost to consumers.”
Through this new approval pathway, biological products are approved based on demonstrating they are biosimilar to, or interchangeable with, a biological product that is already approved by the FDA, which is called a reference product.
The following three guidance documents provide the FDA’s current thinking on key scientific and regulatory factors involved in submitting applications for biosimilar products to the agency.
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: The draft guidance is intended to assist companies in demonstrating that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting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 the FDA. This draft guidance describes a risk-based “totality-of-the-evidence” approach that the FDA intends to use to evaluate the data and information submitted in support of a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.
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.
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 the FDA, addressing differences in formulation from the reference product, how to request exclusivity and other topics.
FDA will seek public comment on the guidance documents and instructions on how to submit comments will be announced in an upcoming Federal Register notice. In finalizing the guidance documents, the agency will consider the information received from the public.