Pegfilgrastim-CBQV(Coherus BioSciences)

Despite the sudden supply hurdle, Theratechnologies is confident that it can “avoid any impact on patients in 2025,” the company’s CEO, Paul Lévesque, said in a statement. Theratechnologies' reliance on a small pool of contract manufacturers has come back to bite the Quebecois biopharma, which announced Tuesday that supplies of its HIV med Egrifta SV could soon run short.Egrifta SV—approved to reduce excess abdominal fat in HIV patients with lipodystrophy—is at risk of facing a “temporary supply disruption” in early 2025, Theratechnologies warned in a release.The reason behind the supply squeeze? An “unexpected voluntary shutdown” of one of Theratechnologies’ contract manufacturer’s facilities following a disappointing FDA inspection, the company said.Despite the sudden supply hurdle, Theratechnologies is confident that it can “avoid any impact on patients in 2025,” the company’s CEO, Paul Lévesque, said in a statement. Theratechnologies will work closely with its manufacturer and the FDA to resume production of its HIV drug, the CEO added.In the meantime, Theratechnologies is rolling out measures to manage inventory of Egrifta SV to help meet patient demand until early January. The company estimates that its efforts will siphon some $1.6 million from the company’s expected revenue in the 2024 fiscal year. Taking a closer look at the situation, Theratechnologies’ Egrifta SV manufacturer recently undertook a three-month voluntary shutdown of its facility to address observations made during a prior FDA inspection. The issues at hand relate to the manufacturing environment at the contractor’s plant, rather than production of Egrifta SV itself, Theratechnologies stressed.The manufacturer is finalizing remediation measures and informed Theratechnologies that it plans to restart production by mid-October, according to Theratechnologies' release. Under the current plan, a batch of the drug is set to be manufactured on Oct. 21, Theratechnologies added.The company did not name the contract manufacturer associated with the supply disruption.As it stands, Theratechnologies depends exclusively on Bachem and Jubilant for production and supply of all raw materials, drug substance and drug product related to Egrifta SV, the company stated in its most recent annual report.In the report, Theratechnologies noted that there are a “limited number” of qualified manufacturers with the necessary know-how and capacity to manufacture the company’s drug substance and drug product. Replacing third-party manufacturers is a pricey and time-consuming endeavor, the company added, noting the process could take 2 or 3 years. Theratechnologies’ supply hiccup is the second caused by third-party manufacturing problems in less than a week.On Friday, Coherus revealed that its Neulasta biosimilar Udenyca would suffer a temporary supply disruption, with stocks of the drug likely to be “substantially depleted" by the middle of October.Coherus blamed the issue on “over-commitments and capacity constraints” facing the U.S.-based contract manufacturer in charge of the cancer biosimilar’s final packaging.