Biologics

Q & A Final Guide on Biosimilar Development

FDA has posted a final guidance entitled “Questions and Answers on Biosimilar Development and the BPCI Act.” The document provides answers to common questions from prospective applicants and other interested parties regarding section 351(k) of the Public Health Service Act, which was added by the Biologics Price Competition and Innovation Act of 2009.

The question and answer (Q&A) format is intended to inform prospective applicants and facilitate the development of proposed biosimilar products and proposed interchangeable biosimilar products, as well as describe FDA’s interpretation of certain statutory requirements.

FDA says it believes that guidance for industry that provides answers to commonly asked questions regarding FDA’s interpretation of its biosimilar regulations will enhance transparency and facilitate the development and approval of biosimilar and interchangeable products. In addition, these Q&As respond to questions the agency has received from prospective applicants regarding the submission of BLAs for biosimilar and interchangeable products, it adds.

FDA Safety Concerns Complicate Plan to Expand Peptide Compounding

The Trump Administration is developing a temporary policy that would allow compounding pharmacies to dispense certain unapproved peptides despite earlier FDA scientific assessments finding insufficient evidence of their safety and effectiveness, setting up a potential conflict between administration policy and the agency's scientific reviewers. Federal officials are considering

DoJ Enforcement Directive Signals More Scrutiny of FDA-Regulated Firms

A new Department of Justice directive identifying violations of the Federal Food, Drug, and Cosmetic Act (FDCA) among potential targets for fraud enforcement could expose FDA-regulated firms to increased federal investigations and criminal prosecutions, according to an analysis by attorneys at Holland & Knight. The 10/1 directive outlines

Guide on Biosimilar Postapproval Manufacturing Changes

FDA has released a final guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products — Questions and Answers.” The document explains how manufacturers should document and report changes to approved biosimilars, including changes involving manufacturing processes, production facilities, dosage forms and strengths. Regarding information required for postapproval manufacturing changes,

Q & A Final Guide on Biosimilar Development

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FDA Safety Concerns Complicate Plan to Expand Peptide Compounding

DoJ Enforcement Directive Signals More Scrutiny of FDA-Regulated Firms

Guide on Biosimilar Postapproval Manufacturing Changes

FDA Warns of Philips Ultrasound Malfunction Linked to Four Deaths