One sentence buried more than 1,500 pages into a fiscal 2020 spending bill the U.S. Senate passed Thursday could open the door to a broader range of insulin biosimilars.

The provision, requested by the FDA, expands the definition of a “biological product” to include chemically synthesized polypeptides.

Part of a $1.4 trillion appropriations package that must be signed into law by midnight Friday to avoid a government shutdown, the bill also includes provisions to streamline the transition of insulin and other drugs that will be “deemed” biologics March 23, in keeping with a mandate in the Biologic Price Competition and Innovation Act (BPCIA).

Wrapped into the 2010 Affordable Care Act (ACA), the BPCIA gave the FDA 10 years to transition approved new drug applications (NDAs) for small proteins like insulin to biologic license applications (BLA). However, the bill expressly excluded chemically synthesized polypeptides from the transition.

That exclusion would have put chemically synthesized follow-ons to transitioned insulins in a bit of a regulatory no-man’s land, as it would have prevented them from coming to market as biosimilars or interchangeables. And since they wouldn’t be able to reference a product whose NDA had been deemed a BLA, they also would have been denied the generic pathway, which is limited to follow-ons listing approved NDAs.

Thus, the only option would be for the synthesized polypeptides to be developed as new drugs, “which could be much more resource-intensive,” the FDA’s Anna Abram and Janet Woodcock said in explaining the need to eliminate the exclusion.

“Removing this exclusion will help patients because it provides the potential for chemically synthesized follow-on insulins and other protein products to come to market through more efficient abbreviated pathways, regardless of how they are manufactured,” they said.

There is another benefit. “In addition to expanding access to lower-cost biosimilar and interchangeable protein products, removing this exclusion will help to promote potential innovation in manufacturing methods, which could lead to future efficiencies in manufacturing processes,” Abram and Woodcock said.

Countering guidance

To ease the transition for the deemed biologics and ensure that potential follow-ons don’t get delayed in the process, the spending bill counters draft guidance the FDA issued on how it intended to make the transition. While the agency had said the deemed biologics would lose all their unexpired exclusivities, except those for orphan drugs, the spending bill allows the products to also keep any remaining pediatric exclusivity.

Another change from FDA guidance is the cutoff date for applications still under review. The FDA had said that, come March 23, it would no longer approve pending or tentatively approved 505(b)(2) applications that referenced an NDA that had been deemed a BLA.

But the spending bill requires the FDA to continue its review of 505(b)(2) and 505(j) applications that were submitted by March 23, 2019. If those applications are approved, they are to be deemed BLAs.

The appropriations package, which consists of two spending bills, also repeals the medical device tax and includes a measure that will allow sponsors of biosimilars and generic drugs to sue innovators that block access to samples needed for the development of follow-on products. In addition, the bills add $2.6 billion to the NIH’s 2020 funding, for a record total just shy of $42 billion, and give the FDA a $91 million in discretionary funds, bringing that part of the agency’s coffers to $3.16 billion.

Aside from the appropriations bill, the device tax may have been a casualty of the Fifth Circuit Court of Appeals’ split decision Wednesday in Texas v. U.S. in which the federal appellate court ruled that the ACA’s individual mandate to have health care coverage is unconstitutional. The device tax and a separate excise tax on drugs were created by the ACA to help pay for the health care exchanges that are a big part of what’s commonly referred to as Obamacare.

The Fifth Circuit remanded the case to the lower court for a more in-depth analysis of whether the ruling should bring down the entire law, including the BPCIA, or just the portions of the ACA related to Obamacare. In a ruling a year ago in the case, U.S. District Judge Reed O'Connor invalidated the entire ACA on constitutional grounds and because of its lack of a severability clause.

Meanwhile, California Attorney General Xavier Becerra said Thursday he plans to move swiftly to challenge the Fifth Circuit’s decision. California is one of several states that entered the suit to keep the ACA intact.

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