Sarclisa On-Body Injector Approval Shows How FDA Regulates Combination Products

The US Food and Drug Administration has approved subcutaneous Sarclisa (isatuximab-irfc) Escena for multiple myeloma across all existing indications of the intravenous version, Sanofi said on July 10. The company said the antibody is the first anticancer treatment to be given through both an on-body injector and manual subcutaneous injection.

The injector is Enable Injections' CirCLIQ, which Sanofi described as a hands-free device that delivers high-volume medicines under the skin with the push of a button, using a retractable 30-gauge needle. According to Sanofi, approval was supported by the pivotal IRAKLIA Phase 3 non-inferiority study, which compared the subcutaneous version given by the injector with intravenous infusion. BioPharm International reported that the same format was approved in the EU in June 2026.

A biologic paired with a delivery device is a familiar regulatory problem. FDA treats such pairings as combination products, a category with its own rules for who reviews them and how they are made.

What counts as a combination product

FDA's combination products page describes them as products that “combine drugs, devices, and/or biological products.” Because their parts would normally fall under different authorities, and often different FDA centers, the agency says they raise challenges for every stage from preclinical testing to post-approval changes.

The formal definition sits in 21 CFR Part 3. It covers four arrangements: parts that are physically or chemically combined into a single entity; separate drug, device or biological products packaged together as a unit; a product sold separately but labeled for use only with a specific approved product, where both are needed for the intended effect; and the investigational equivalent of that last case.

Who leads the review

FDA has three medical product centers: one for drugs, one for biologics and one for devices. The regulation assigns a combination product to one of them by its primary mode of action, defined as “the single mode of action of a combination product that provides the most important therapeutic action of the combination product.” If that action is a drug's, the drug review component has primary jurisdiction; if a device's, the device component; if a biological product's, the biologics component.

When FDA cannot say with reasonable certainty which mode of action contributes most, the rule sends the product to the center that regulates other combination products raising similar safety and effectiveness questions, or, failing that, to the center with the most relevant expertise. Assigning a lead center does not shut the others out: the regulation says it “does not preclude consultations” with other components or, in appropriate cases, a requirement for separate applications.

A company unsure of the answer can file a request for designation, which the regulation says should come before any premarket application. FDA's product jurisdiction officer is to issue a letter of designation within 60 days of the filing date.

How the parts are made

Manufacturing follows the parts. Under 21 CFR Part 4, drug good manufacturing practice rules in parts 210 and 211 apply to a combination product with a drug constituent, and the device quality management system rules in part 820 apply to one with a device constituent. Biological product requirements apply to a biologic constituent as they would on their own.

For co-packaged and single-entity products, the regulation lets a manufacturer run one operating system built on either the drug or the device rules, provided it also shows compliance with specified provisions of the other set. Where the two parts are made at separate facilities, each facility must meet the full requirements for its own type of part.