Executive Briefing Series (formerly The Food & Drug Letter)

After much anticipation, the FDA earlier this month released three draft guidance documents on biosimilars, paving the way for implementation of the 2009 Biologics Price Competition and Innovation Act and an abbreviated pathway mandated by the 2010 Affordable Care Act. The first two guidances explain the scientific and quality issues drugmakers should consider in demonstrating biosimilarity to a reference product. The third, presented in a Q&A format, addresses when products are biosimilar versus interchangeable, provisions related to the requirement to submit a biological license application and exclusivity. Together, they provide a detailed map for navigating the biosimilars application and review process and suggest areas — such as the choice of clinical endpoints to support a proposed biosimilar — where the FDA may be flexible. This issue of The Food & Drug Letter provides a broad-brush view of how the FDA conceives biosimilars regulation, how other countries are dealing with them and some of the marketing challenges facing biosimilars companies.

The FDA has issued three long-awaited biosimilars guidance documents, recommending a stepwise approach to showing biosimilarity that could allow eased trial requirements if a sponsor can demonstrate biosimilarity in earlier steps.

All biosimilars applications should contain a chemistry, manufacturing and controls section, according to a draft guidance on quality considerations.

Sponsors should request an initial meeting with the FDA where they can provide a plan for the development program, manufacturing process information and preliminary comparative analytical data, the third guidance states.

To better understand the demands facing FDA reviewers, the agency’s proposed user fee program seeks an independent study of workload volume and full costs associated with reviewing biosimilars applications.

The FDA plans to issue draft guidance by mid-2014 on the various product development meetings included in its proposed biosimilars user fee program.

The European Medicines Agency (EMA) wants to update its guideline on biosimilar drugs to reflect the growing complexity of biosimilar products and unique issues concerning their development.

Since 2005, when the European Medicines Agency (EMA) adopted an overarching general guideline on biosimilars, a number of other regulatory jurisdictions have sought to define biosimilars and frame expectations for their approval.

Biosimilars makers are intimately familiar with certain hurdles for success in the marketplace — untested regulatory pathways, patent challenges and manufacturing issues.