Novo Nordisk, Inc.

iStock, Victor Golmer Wednesday’s update to the regulator’s drug shortage database is good news for Novo Nordisk, which has struggled to keep up with demand for the blockbuster GLP-1 drugs. All doses of Novo Nordisk ’s semaglutide—sold as Ozempic for type 2 diabetes and as Wegovy for obesity—are now available, according to a Wednesday update to the FDA’s drug shortages database. Still, the regulator’s webpage continues to list semaglutide’s status as “currently in shortage.” It is unclear if compounders will need to stop producing and marketing their remixed versions of semaglutide due to Wednesday’s supply update—or if the FDA will enforce action against these pharmacies. Earlier this month, the FDA announced that it was rethinking the shortage status of Eli Lilly’s tirzepatide brands Mounjaro and Zepbound—which the regulator had taken off its shortage list just days earlier—after a complaint from the Outsourcing Facilities Association (OFA). In its lawsuit, the trade group called the FDA “reckless” in declaring the end of the tirzepatide shortage, noting that the decision could “deprive patients of a vital treatment for type 2 and obesity.” Currently, the FDA still officially considers the tirzepatide shortage to be “ resolved ,” according to its website. It remains to be seen whether the OFA will similar complaint for semaglutide. Wednesday’s supply update comes after nearly a year of aggressive manufacturing investments from Novo. In November 2023, the pharma announced a $6 billion boost to its production capacity in Denmark, dedicated for a multi-product facility focused on active pharmaceutical ingredients. Novo in March 2024 also injected $556 million into its Chinese operation, following it up in June 2024 with a $4.1 billion commitment to its manufacturing footprint in North Carolina. Novo Holdings, the controlling shareholder of Novo Nordisk, announced in February 2024 its $16.5 billion acquisition of CDMO giant Catalent. In a related $11 billion deal, Novo Holdings plans to sell three of Catalent’s sites to Novo Nordisk to help expand production of its GLP-1 drugs. However, the Novo Holdings-Catalent buyout is facing opposition. Earlier this month, Sen. Elizabeth Warren (D-Mass.) urged Federal Trade Commission Chair Lina Khan to “carefully scrutinize” the Catalent deal which, if allowed to push through, will give Novo “unprecedented visibility into and control over its competitor’s production capacity, costs, and business practices.” Lilly CEO David Ricks said in a Q2 earnings call in August that the company remains concerned about the Novo-Catalent deal. “We’ve aired those concerns publicly and privately since the proposed transaction was announced, and we’re waiting to see what happens,” Ricks told analysts. Last week, Roche CEO Thomas Schinecker urged regulatory authorities to block Novo Holdings’ buyout of Catalent, arguing that the deal would have wide-ranging negative effects on the industry. “Limiting the competition in this space is not a good idea,” Schinecker said in a media call. However, he insisted that Roche would not be affected by the deal but it “could be a problem for other smaller players,” according to Reuters . Unions, consumer groups and public interest organizations have also raised concerns about the acquisition, noting in a letter to Khan that the merger “would be harmful to competition across various therapeutic areas.”

The FDA on Tuesday released an inspection report sent to Novo Nordisk earlier this year citing quality-related issues at a site in Kalundborg, Denmark, that manufactures its blockbuster semaglutide drugs and its long-acting insulin. The heavily redacted Form 483 includes eight observations related to the site’s quality, following a seven-day FDA inspection in March. Among the observations are ones related to adequately describing critical process parameters and in-process controls for drug substance manufacturing and processing unit operations. “Master production and control records lack complete manufacturing and control instructions,” the 483 said. The agency also noted that the responsibilities and procedures applicable to the site’s quality control unit “are not fully followed,” and that lab controls at the facility “do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that production cultures conform to appropriate standards of identity, strength, quality, and purity.” “This is the manufacturing process we referred to when we received the CRL for Awiqli from the FDA in July,” a Novo spokesperson told Endpoints News in an email. “We continue to be in contact with the FDA and do not expect to resolve as related to Awiqli this year.” The FDA in July issued a complete response letter to Awiqli, which is approved in the EU, Canada and other markets. At that time, the regulator requested more information relating to the manufacturing process. The company said last November that it would invest more than DKK 42 billion (about $6 billion) to expand existing manufacturing facilities in Denmark, including the Kalundborg site, mainly to increase its capacity for active pharmaceutical ingredients. Back in August, nearly all versions of Novo’s GLP-1 drugs — Wegovy and Ozempic — were taken off the FDA shortage list, and the company reported that prescriptions had doubled in the US since the beginning of the year. “We’re scaling our supply and now we’re serving twice as many people with Wegovy today compared to just at the beginning of the year and we continue to scale,” CEO Lars Fruergaard Jørgensen said at the time.

This week, Roche joined Eli Lilly in coming out against a deal that would add significant new manufacturing capacity to Novo Nordisk, to help it meet some of the huge demand for its GLP-1 drugs Wegovy and Ozempic. Like every major pharma merger, Novo’s deal to buy several manufacturing plants from contract manufacturer Catalent has been under antitrust review by the Federal Trade Commission. But Lilly and Roche’s opposition is a new twist in the M&A world. Lilly is, of course, Novo’s biggest rival in the anti-obesity space. And Roche has its own anti-obesity drugs in development. There is a fair argument that Novo needs the deal to meet demand. Its drugs are in shortage, and Lilly’s competing drug just came off the official shortage list. Lilly has been investing heavily in building more capacity, and compounding pharmacies are also serving a significant portion of the market. For now, capacity constraint — more than efficacy data — has been the defining characteristic of the market for anti-obesity drugs. So why not hobble your biggest rival by sticking a wrench in a deal that would help them compete? One broader argument against the deal is that Catalent is one of the biggest contract manufacturers in biopharma, and selling itself to Novo Holdings, which owns a big chunk of Novo Nordisk, could concentrate manufacturing and development capacity in a problematic way. (There is also the interesting fact that, if you dig back into the SEC filings around the Catalent sale, several of Catalent’s business partners — likely code for big pharma customers — took a look at buying the manufacturer. I’d be very interested to know who they were in the context of the opposition to the deal. Please feel free to drop me a line if you know!) All of that said, I’m having a hard time remembering the last time that one set of big drugmakers was pushing antitrust regulators to oppose a merger by another major member of the industry. If anything, pharma has looked at the FTC as overreaching on deals (Amgen-Horizon, Sanofi-Maze) that might not have gotten much of a look in prior years. Roche and Lilly trying to throw a wrench in the deal is proof of just how big the stakes are in obesity. But if they win the argument with antitrust regulators, they might regret it the next time they’re seeking to do a deal of their own. — Drew