New guidance on generic opioids, biosimilars labeling coming from FDA

March 2, 2015

FDA’s Center for Drug Evaluation and Research (CDER) will release a document designed to provide manufacturers with guidance on the evaluation of abuse-deterrent properties of generic opioids by the end of 2015. It will also release a document on biosimilars product labeling in the same time period.

FDA’s Center for Drug Evaluation and Research (CDER) will release a document designed to provide manufacturers with guidance on the evaluation of abuse-deterrent properties of generic opioids by the end of 2015. It will also release a document on biosimilars product labeling in the same time period.

Related: Adoption of fast-growing biosimilars segment essential

Guidance for biosimilars labeling will include FDA’s decision on generic names for specific biosimilar products. This is an important decision given the fact that there are slight differences between biosimilars and the biologicals from which these drugs derive. Side effects, for example, may vary, so potentially labeling the biosimilars with individual suffixes may aid in the reporting of adverse events.

Related:Once-daily opioid formulated with abuse-deterrent properties now available

Guidance for generic opioids and their abuse-deterrent properties is seen as a response to an ongoing controversy. Newly approved opioids have frequently been non-abuse resistant, but subsequent reformulations have been devised by manufacturers to be more abuse resistant, often replacing the first opioid version on the market. However, because the initial version of a non-abuse-resistant opioid generally has its patent or marketing exclusivity expire first, generic opportunities become available off of its original formulation.

So, FDA may end up approving a generic version of the non-abuse deterrent drug from a generic manufacturer. The concern from both legislators and biopharmaceutical trade groups remains that such generic versions of these opioids may increase abuse rates among patients prescribed these drugs. It is hoped that the new guidance document from FDA will help resolve this issue.

Related:ER opioid analgesiac with abuse-detterent properties approved by FDA

The forthcoming “General Principles for Evaluating Abuse-Deterrent Properties of Generic Solid Oral Opioid Drug Products” is 1 of 5 documents in the generics category and is new to the overall list. The other expected release, “Labeling for Biosimilar Biologicals Products,” is 1 of 4 documents in the biosimilarity category.

These documents are among over 90 guidance documents CDER anticipates finalizing or releasing this year. For the most up-to-date list of planned documents to come from CDER, see its “Guidance Agenda” at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM417290.pdf