Special report: FDA oversight of 'biosimilars' facing complaints
Safety, costs among the issues to be weighed as FDA grapples with crafting an approval process for generic versions of biological medicines
The specific approach that the U.S. Food and Drug Administration takes in defining the regulatory approval process for generic versions of biological medications could determine if such a market ever launches in this country.
The federal agency jumped into the complex issue this year when it began to craft guidance for determining the safety and effectiveness of generic versions of the protein-based drugs, also known as biosimilars or follow-on biologics, as called for in the Patient Protection and Affordable Care Act. The agency has not specified what its process will require but healthcare experts expect it to address testing requirements and whether, and to what extent, datasharing is required between brand-name and generic manufacturers.
The FDA’s proposed guidance on an approval path for biosimilars—expected as early as this summer—was authorized under a section of the 2010 reform law called the Biolog- ics Price Competition and Innovation Act. Supporters of that measure say it was needed to lower the cost of biological drugs, which range from insulin to cancer treatments, and are generally more effective and more costly than chemical pharmaceuticals.
Both brand-name versions of those drugs and biologics that are similar to generics were previously approved under an identical costly and lengthy process.
But meeting extensive requirements in a new process could cost too much and take too long to make the development of biosimilars worthwhile, according to some.
“In the end, the amount of work that will be required in a biosimilar pathway will have a pretty direct impact on the market attractiveness of producing biosimilar products in different therapeutic areas and for different diseases,” says Terry Hisey, vice chairman and life sciences leader at consultancy Deloitte.
The concern that the FDA will develop overly burdensome regulatory requirements and smother the U.S. biosimilars market in its infancy is a concern shared by some patient advocates and members of Congress.
“If the hurdles are too high then it will really limit the availability of these medications,” says Paul Brown, government relations manager for the National Research Center for Women & Families, a not-for-profit, liberal health advocacy organization based in Washington.
Sen. Bernie Sanders (I-Vt.) wrote to the FDA in 2010 that an aggressive regulatory process would interfere with the purpose of the biosimilar approval law. In particular, Sanders wrote, any requirement that generic biologic makers conduct their own trials would violate medical ethics, specifically the Declaration of Helsinki on ethical principles for medical research involving humans. He cites the requirement in the declaration to immediately stop a study and proceed to widespread product availability when there is “conclusive proof of positive and beneficial results,” noting that mandating additional trials where research has already produced definitive findings would only put humans at unnecessary risk.
Sanders introduced legislation last year that would require regulators to accept such previous clinical trial data, which biosimilar manufacturers could purchase from the name-brand drugmaker, as part of biosimilar drug applications.