For Immediate Release: Feb. 9, 2012
Media Inquiries: Sandy Walsh, 301-796-4669;
sandy.walsh@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA issues draft guidance on biosimilar product
development
The U.S. Food and Drug Administration today issued three draft
guidance documents on biosimilar product development to assist
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, M.D., director of FDA’s Center for Drug Evaluation
and Research. “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.”
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 -- under
section 351(k) -- for biological products that are demonstrated to
be highly similar (biosimilar) to or interchangeable with an
FDA-licensed biological product.
Biological products are therapies used to treat diseases and
health conditions. They include a wide variety of products
including vaccines, blood and blood components, gene therapies,
tissues, and proteins. Unlike most prescription drugs made through
chemical processes, biological products generally are made from
human and/or animal materials.
A biosimilar is a biological product that is highly similar to
an already approved biological product, notwithstanding minor
differences in clinically inactive components, and for which there
are no clinically meaningful differences between the biosimilar and
the approved biological product in terms of the safety, purity, and
potency.
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.
FDA is seeking public comment on these draft guidance
documents:
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The draft guidance is intended to assist companies in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. 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
characterization 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
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.
For more information
•
FDA: Biosimilars
•
Scientific Considerations in Demonstrating Biosimilarity to a
Reference Product
•
Quality Considerations in Demonstrating Biosimilarity to a
Reference Protein Product
•
Biosimilars: Questions and Answers Regarding Implementation of the
Biologics Price Competition and Innovation Act of 2009
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation’s food supply, cosmetics, dietary supplements,
products that give off electronic radiation, and for regulating
tobacco products.