The FDA recently issued draft guidance documents on the development of biosimilars—biological products that are highly similar to currently approved ones, with minor differences in clinically inactive components—to help bring such products into the market. The documents are designed to enhance competition and lead to better access and lower cost to patients. The less expensive versions of approved biologic medications will be used for treatment of patients with a variety of conditions, including rheumatoid arthritis.
The Patient Protection and Affordable Care Act, signed into law by President Obama on March 23, 2010, amended the Public Health Service Act to create an abbreviated approval pathway for biological products that are demonstrated to be highly similar to or interchangeable with an FDA-licensed biological product. There are no clinically meaningful differences between the biosimilar and the FDA-approved biological product (reference product) in terms of safety, purity, and potency.
The FDA's current thinking on scientific and regulatory factors involved in submitting applications for biosimilar products is provided in the following guidance documents:
• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product is intended to help companies demonstrate that a proposed therapeutic protein product is biosimilar to a reference product for the purpose of submitting an application.
• Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product 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 an application.
• Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 provides answers to common questions that may arise in the early stages of product development, such as how to request meetings with the FDA.
The 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. Licensed biosimilar and interchangeable biological products will be required to meet the agency's standards of safety and efficacy.