FDA withdraws draft guidance on biosimilars
In a move that Food and Drug Administrator Scott Gottlieb said was aimed at better supporting companies developing biosimilars, the agency has withdrawn its most recent draft guidance.
The “Statistical Approaches to Evaluate Analytical Similarity” draft guidance was issued in September 2017 and was intended to offer manufacturers advice about how the agency evaluates analytical similarity between the biosimilar and its reference drug. The decision to withdraw the draft guidance was based on public comment that the FDA received in the aftermath of issuing it, the agency said.
Key factors in the decision included comments noting that the number of reference product lots biosimilar developers would need to purchase under the draft guidance if it were finalized could impact cost and efficiency.
“One of the central aspects of biosimilar development and approval is the analytical studies performed to demonstrate that a biosimilar is highly similar to the reference product,” Gottlieb said. “We’re taking a fresh look at our draft recommendations for evaluating analytical studies in order to ensure our guidance takes into consideration the most current and relevant science. We’ll continue to work directly with biosimilar developers on their programs as we develop new draft guidance in this area.”
The agency said it would be issuing a new draft guidance in the future that would support more updated techniques in analytical data evaluation to support demonstrating that a biosimilar is highly similar to a reference drug. Future draft guidance also will focus on offering sponsors flexibility to help spur developing biosimilars without compromising the agency’s scientific standards, it said.
“Biosimilars foster competition and can lower the cost of biologic treatments for patients, yet the market for these products is not advancing as quickly as I hoped,” Gottlieb said. “I believe that the FDA can do more to support the development of biosimilars, as well as promote the market acceptance of these products. As the cost to develop a single biosimilar product can reach hundreds of millions of dollars, it’s important that we advance policies that help make the development of biosimilar products more efficient, and patient and provider acceptance more certain,”
The “Statistical Approaches to Evaluate Analytical Similarity” draft guidance was issued in September 2017 and was intended to offer manufacturers advice about how the agency evaluates analytical similarity between the biosimilar and its reference drug. The decision to withdraw the draft guidance was based on public comment that the FDA received in the aftermath of issuing it, the agency said.
Key factors in the decision included comments noting that the number of reference product lots biosimilar developers would need to purchase under the draft guidance if it were finalized could impact cost and efficiency.
“One of the central aspects of biosimilar development and approval is the analytical studies performed to demonstrate that a biosimilar is highly similar to the reference product,” Gottlieb said. “We’re taking a fresh look at our draft recommendations for evaluating analytical studies in order to ensure our guidance takes into consideration the most current and relevant science. We’ll continue to work directly with biosimilar developers on their programs as we develop new draft guidance in this area.”
The agency said it would be issuing a new draft guidance in the future that would support more updated techniques in analytical data evaluation to support demonstrating that a biosimilar is highly similar to a reference drug. Future draft guidance also will focus on offering sponsors flexibility to help spur developing biosimilars without compromising the agency’s scientific standards, it said.
“Biosimilars foster competition and can lower the cost of biologic treatments for patients, yet the market for these products is not advancing as quickly as I hoped,” Gottlieb said. “I believe that the FDA can do more to support the development of biosimilars, as well as promote the market acceptance of these products. As the cost to develop a single biosimilar product can reach hundreds of millions of dollars, it’s important that we advance policies that help make the development of biosimilar products more efficient, and patient and provider acceptance more certain,”