Following FDA rejections, Regeneron and Scholar Rock are turning to other facilities to clear regulatory logjams created by quality problems at an ex-Catalent facility in Indiana. Novo Nordisk, meanwhile, has been tight-lipped about whether its own FDA applications have been affected.
One way or another, companies derailed by quality problems at a Novo Nordisk plant are edging toward solutions. An FDA reinspection of the facility offers Novo’s partners one path forward. Yet having suffered complete response letters due to the quality problems, Regeneron and Scholar Rock have already advanced efforts to end their reliance on the facility.
The Bloomington, Indiana, site is one of three former Catalent facilities that Novo acquired for $11 billion last year as it tried to keep up with demand for its GLP-1 drugs. As a contract development and manufacturing organization (CDMO), Catalent had used the facility to provide fill/finish services to biopharma companies.
Regeneron has received a series of complete response letters (CRLs) starting in 2023 because FDA inspectors found problems at the Indiana site. Scholar Rock received a CRL linked to the facility in September. The impact could be more widespread than those publicly disclosed rejections suggest. On an earnings call in late October, Regeneron CEO Leonard Schleifer said “the biggest companies in the world have had the same issue” at this and other fillers but kept quiet about the CRLs.
With CRLs delaying approvals and the plant receiving an Official Action Indicated (OAI) classification in October, indicating an unacceptable state of compliance, Regeneron and Scholar Rock have stepped up efforts to craft paths to market that do not rely on the Indiana facility.
On an earnings call in November, Scholar Rock CEO David Hallal said his team “accelerated our timelines for an additional vialer” after the OAI classification. While the biotech began looking into adding another U.S.-based fill/finish facility after Novo bought the Catalent facility, it pulled forward its plans in response to the OAI classification and CRL for its drug candidate apitegromab in spinal muscular atrophy (SMA).
Scholar Rock has secured commercial fill/finish capacity, a task Hallal said can be a lengthy process, from early 2026. The new provider successfully completed recent site inspections. Tech transfer is underway, the CEO said, and the team is aiming to include the site in an approval filing in 2026. BMO analysts raised the probability of success for apitegromab in SMA to 80% in response to the update.
“As we have seen throughout 2025, the more biotech manufacturers can plan for unforeseen CMC issues, the less likely they are to face challenges with FDA approvals,” the analysts said. “Scholar Rock’s expedited transfer for this second fill finish acknowledges this reality and could provide comfort for investors who still are wary of another Catalent site reinspection.”
The biotech took the actions despite Novo progressing toward a reinspection of the facility. Hallal said Novo representatives joined Scholar Rock at a meeting with the FDA in November and “detailed the progress they have made in implementing their remediation plan at the Bloomington facility.” The Novo team affirmed that they expect the facility to be ready for reinspection by the end of this year, Hallal said.
Regeneron Brings Fill/Finish In-House
Regeneron’s push to insulate itself from unforeseen CMC issues includes the construction of an in-house fill/finish plant. Schleifer said on the October call that the site is “ready to go, and we expect it to come online during the coming year.” A Regeneron spokesperson told BioSpace via email that the CEO was referring to a facility in Rensselaer, New York, that the company included in the $7 billion investment it unveiled in April.
The spokesperson declined to answer questions about how many fill/finish lines will be active when the plant opens or about Regeneron’s plans for adding more lines over time. Schleifer was more forthcoming at a Morgan Stanley event in September, telling attendees that the facility will start with one line. Regeneron plans to take back some of the Dupixent filling that is currently handled by its partner Sanofi, he said, and over time, he expects to set up four lines to handle the company’s internal filling needs.
While Regeneron is now on the cusp of lessening its reliance on third parties, analysts have questioned the company’s recent vulnerability to problems at CDMO partners. Schleifer addressed this concern on the October call, telling analysts that the company recognized it would “be more ideal if we could have our own filling” and explaining that efforts to add capacity were “delayed dramatically during COVID.” Adding back-up third-party sites has been a slow process too.
“We’ve been working on backups for quite a long time now,” Schleifer said, explaining that “the FDA is very finicky about showing where you’re going to make the product, literally what equipment it’s going to touch. Then you have to do stability testing and . . . quality testing—all that for a given filler. That takes quite a bit of time, quite a bit of resources.”
The time required to add fillers looked set to trigger another CRL for Eylea HD vials. Regeneron CFO Christopher Fenimore said at a Jefferies event on Nov. 17 that “if there is no compliant filler on the BLA, and really the only one that it could be at this point is Catalent, we would expect to get a CRL.” Two days later, however, Regeneron said the FDA had approved Eylea HD in macular edema after retinal vein occlusion and for monthly dosing across approved indications.
In response to BioSpace’s question about what changed between Fenimore’s comments and the FDA approval, a Regeneron spokesperson declined to elaborate beyond the press release announcing the approval. The press release lacks information on the production of Eylea HD, although it notes that Regeneron is still working with the ex-Catalent site to resolve issues that prevented the approval of a prefilled syringe product.
BMO Capital Markets analysts said in a note to investors that the “approval comes as a welcome surprise as regulatory issues are starting to show signs of improvement.” Another test of whether Regeneron’s regulatory issues are improving is coming up, with the company planning to refile for approval of a prefilled Eylea HD syringe in January. The timing is tied to validating a new third-party filler.
Novo Contends With FDA Rejection
While Regeneron and Scholar Rock can pivot away from the Indiana site, Novo’s $11 billion investment in the facility and two other plants gives the Danish drugmaker tighter ties. The Catalent purchase contributed to a 39% increase in cost of goods sold at Novo in the third quarter.
Novo revealed a CRL for a multidose version of Wegovy in November. Asked via email if issues at the Indiana site were a factor in the CRL, a Novo spokesperson referred BioSpace to the company’s third-quarter earnings call. David Moore, executive vice president of U.S. operations at Novo, answered a question about the CRL on the earnings call without commenting on manufacturing.
The company said in its third-quarter earnings report that the CRL provided “recommendations related to the co-existence of the multi-dose pen with the single-dose pen already on the market.” Novo added that it was addressing FDA’s feedback and would continue to engage with the agency on the application.
