The FDA recently released its 2014 New & Revised Draft Guidances agenda for its Center for Drug Evaluation and Research (CDER ), listing the guidance documents that will be released throughout the year.
You might notice a particular emphasis on biotech, specifically bioequivalence. The FDA has two Guidance documents on biopharmaceutics and five guidance documents on biosimilars planned for 2014 — the most ever released in one year. The Guidance documents are as follows:
CATEGORY — Biopharmaceutics
• Bioavailability and Bioequivalence Studies Submitted in NDA’s or INDs for Orally Administered Drug Products – General Considerations
This draft guidance contains recommendations for submission of bioavailability and bioequivalence studies for investigational new drugs (INDs) and new drug applications (NDAs).
• Dissolution Testing and Specifications Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutical Classification System Class 1 and 3 Drugs
In addition to data from bioequivalence studies, other data may need to be submitted to meet regulatory requirements. This guidance provides general standards about dissolution testing and, most notably, further clarifies the process to determine when dissolution testing is sufficient to grant a waiver from an in vivo (experimentation using a whole, living organism) bioequivalence studies.
CATEGORY — Biosimilarity
• Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009
• Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product
• Considerations in Demonstrating Interchangeability to a Reference Product
• Labeling for Biosimilar Biological Products
• Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act
As noted by the Biosimilar Law Blog, with the exception of the “Additional Questions and Answers” guidance (which addresses common questions regarding FDA’s interpretation of the BPCI Act of 2009) the proposed biosimilar guidances are not updates to the Biologics Price Competition and Innovation Act but rather new topics not yet fully addressed for implementation of the biosimilars pathway .
The new guidances will address how interchangeability of products (demonstrating that a product is biosimilar to an already-approved biological product) can be achieved, labeling issues associated with biosimilar products and reference product exclusivity. These widely anticipated topics respond to major questions that industry and FDA have been debating over the last five years.
According to the FDA, as of September 17, 2013, the agency had received 56 meeting requests for an initial meeting to discuss biosimilar development programs related to 13 different reference products and had held 47 initial meetings with sponsors. CDER had received 17 Investigational New Drug (IND) Applications for biosimilar development programs, although additional development programs are proceeding under pre-INDs.
The FDA continues to actively engage with Sponsors , including holding development-phase meetings and providing written advice for ongoing development programs for proposed biosimilar products.
