The FDA has finalized its guidance on the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research special protocol assessments (SPA). SPA is a process in which product sponsors may ask to meet with FDA to reach an agreement on the design and size of clinical trials and clinical or animal studies to determine whether they adequately address the scientific and regulatory requirements to support eventual marketing approval.
The FDA has finalized its guidance on the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research special protocol assessments (SPAs). SPA is a process in which product sponsors may ask to meet with FDA to reach an agreement on the design and size of clinical trials and clinical or animal studies to determine whether they adequately address the scientific and regulatory requirements to support eventual marketing approval.
An SPA agreement indicates that the FDA concurs with the adequacy and acceptability of the overall protocol design, though it does not guarantee that the FDA will accept a New Drug Application or a Biologics License Application for the resulting proposed product, or that a marketing application will be approved.
The protocols that are eligible for SPA request are animal carcinogenicity protocols, drug substance and drug product stability protocols, animal efficacy protocols, protocols for trials intended to form the primary basis of an efficacy claim, and protocols needed for clinical studies to demonstrate biosimilarity or interchangeability of proposed biosimilar.
For proposed biosimilar products, protocols will only qualify for the SPA program if the sponsor has conducted a biosimilar biological product development (BPD) type 2 or type 3 meeting with the agency. The FDA says that “These detailed discussions are especially important if the development plan will include trial elements with which there is little past experience.”
If the product sponsor receives a letter indicating that no agreement with the agency has been reached, the sponsor can choose to initiate the trial without an agreement, respond in writing to the FDA to address the nonagreement letter without initiating the trial, or request a meeting to discuss the nonagreement letter.
An SPA agreement can be modified after testing begins if the FDA and the sponsor agree to a change in writing, and, in some cases, the FDA can rescind an SPA agreement (though the guidance notes that fewer than 1% of all SPA agreements have ever been rescinded).
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.