Joseph P. Miletich, M.D., Ph.D., senior vice president of R&D at Amgen, submitted testimony to the FDA stakeholder hearing on biosimilars, urging members of the FDA panel charged with implementing a pathway for biosimilars to establish approval standards that advance patient safety and promote confidence in biosimilars marketed in the U.S.

"Put patients first and sound policy will follow," said Miletich in a press release outlining his testimony. "Amgen appreciates the FDA's efforts on the guidelines and encourages adoption of a thorough review and approval process. However, Amgen believes some changes and additional clarity are needed."

Noting the complexities of biological products and the potential differences in products created from different living cells, Miletich emphasized that biotechnology is an evolving field.  He said the FDA's guidance documents should candidly acknowledge there are some things scientists still do not know today.

Miletich also stressed that "patient safety must be a non-negotiable priority for FDA and manufacturers, and that focus on patient safety does not end with drug approval." He outlined three key recommendations the FDA should consider as it finalizes its guidance:

• Adopt policies to facilitate attribution of adverse events and foster manufacturer accountability
• Conduct a communications campaign about biologics and biosimilars
• Foster supply chain stability

On the first recommendation, Miletich underscored the need for accurate tracking and tracing, the importance of which will increase significantly with the arrival of biosimilars in the U.S. marketplace.

"We believe prompt identification and resolution of product problems will be facilitated by distinguishable established names,” he said. “Unlike other identifiers, established names present a risk that two or more products could share the same name, which would affirmatively confound the attribution of adverse events."

Concerning his second recommendation, Miletich acknowledged that the biosimilar approval pathway is a new initiative in the U.S. with many scientific and administrative challenges and nuances. He believes it will be essential for the FDA to clearly communicate to all stakeholders what biosimilar products are and are not.

“For example,” said Miletich, “there should be no perception, implied or otherwise, that an FDA-approved biosimilar is somehow less effective or less safe than the reference product. However, at this time, biosimilars are not appropriate for automatic substitution—that is, without the explicit consent of the prescribing physician—unless deemed interchangeable by FDA."

For the third recommendation, Miletich emphasized that FDA policy should foster supply chain stability. According to Miletich, recent medicine shortages have been an opportunity for some manufacturers to falsely suggest that FDA's standards are overly rigorous and a source of the drug shortage problem.

“Complex products require high standards,” he said. “It is by maintaining appropriately robust good manufacturing practices and facility inspection standards that FDA assures the public the reliable supply of high quality products."

On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act, which contained a provision authorizing the FDA to create an abbreviated approval pathway for biological products shown to be biosimilar to an already FDA-approved biological medicine. As a result of the FDA public hearing in November 2010 and the FDA's draft guidances on biosimilars issued on Feb. 9, 2012, the U.S. is beginning the implementation process.

Miletich's written testimony was submitted in response to FDA's notice announcing a public hearing and requesting public comments on "Draft Guidances Relating to the Development of Biosimilar Products." His testimony is available here. The deadline for submitting written comments following the hearing is May 25, 2012.