The FDA has issued new draft guidance on how biologic product sponsors should address postapproval changes in chemistry, manufacturing, and controls.
The FDA has issued new draft guidance on how biologic product sponsors should address postapproval changes in chemistry, manufacturing, and controls (CMC).
The draft guidance, prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research, provides recommendations to biologics license application (BLA) holders regarding the types of changes to an approved BLA that can be documented in annual reports. Under FDA regulation, postapproval CMC that have a minimal potential to affect product quality can be documented by BLA holders on a yearly basis, while changes that are considered major require applicants to submit and receive FDA approval of a supplement to the BLA before the affected product can be distributed. Moderate changes require a supplement to be submitted 30 days before product distribution.
The list of CMC changes to be submitted annually include:
If the FDA determines that a CMC change that falls into one of these categories would be more appropriately categorized as a major or moderate change and therefore require a supplement, the FDA will notify the applicant and request further information.
Changes documented in annual reporting should include full descriptions, with details concerning the manufacturing sites involved, the date of the change, a cross-reference relevant to validation protocols or standard operating procedures, relevant data from studies and tests performed to assess the effect of the change on product quality, a list of products involved, and a statement that the effects of the change have been assessed.
The FDA notes that it has produced the new guidance after having observed a steady increase in the number of CMC manufacturing supplements that it has received. An annual submission of CMC changes that have a minimal potential to harm product quality could allow the agency to streamline its processes, in keeping with its current focus on efficiency and the better use of limited resources.
The FDA will accept comments on the draft guidance on docket FDA-2017-D-2802 until October 10, 2017.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
President Trump Signs Executive Order to Bring Down Drug Prices
April 16th 2025To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.
How State Substitution Laws Shape Insulin Biosimilar Adoption
April 15th 2025States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.