Stelara Biosimilar Nods Arrive In US And EU For Fresenius And Formycon

You wait ages for an ustekinumab biosimilar approval, and then two come along at once. That was the situation for allies Fresenius Kabi and Formycon, which on 27 September received formal approvals from both the European Commission and the US Food and Drug Administration for their partnered Otulfi rival to Stelara.

The European approval was a formality after the European Medicines Agency’s Committee for Medicinal Products for Human Use granted a positive opinion for the product at the end of July (see sidebar).

Meanwhile, the US FDA approval has been awaited ever since the firms disclosed a filing late last year, with the product having been developed by Formycon under the codename FYB202. (Also see "Fresenius And Formycon File Ustekinumab In US" - Generics Bulletin, 1 Dec, 2023.)

While the firms had just over a year ago announced a US settlement with Stelara originator Johnson & Johnson allowing a date-certain launch – “no later than 15 April 2025” (Also see "Another US Stelara Settlement Arrives, This Time For Fresenius And Formycon" - Generics Bulletin, 7 Aug, 2023.) – Fresenius said as it announced the FDA Otulfi approval that “in accordance with the patent settlement between Fresenius Kabi, Formycon and Johnson & Johnson, Fresenius Kabi has the right to market Otulfi in the US no later than 22 February 2025.”

This brings the launch more in line with a group of other firms launching in late February, such as partners Teva and Alvotech, as well as Stada and Samsung Bioepis. (Also see "Sandoz Partner Samsung Bioepis Settles On Stelara In US" - Generics Bulletin, 30 Nov, 2023.)

A similar advancement of launch dates occurred with settlers over Humira (adalimumab) in the US, ultimately leading to an initial launch by Amgen at the start of 2023, followed by a second wave in July, even though initially-announced launch dates had been pegged for different dates throughout the back half of that year. (Also see "Generics Bulletin Explains: The Next Wave Of US Humira Biosimilars" - Generics Bulletin, 23 Jun, 2023.)

Again, Amgen is in pole position on Stelara, with launch of its Wezlana (ustekinumab-auub) version expected from 1 January 2025. (Also see "Stelara Settlement Gives Amgen US Ustekinumab Entry Date" - Generics Bulletin, 24 May, 2023.)

In the US, Fresenius noted, Otulfi had “received FDA approval for both subcutaneous and intravenous formulations, to treat the same conditions as Stelara,” covering Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.

Meanwhile in Europe applications were filed and endorsed for two parallel versions: Formycon’s Fymskina for treating of adults and children with plaque psoriasis and adults with psoriatic arthritis, ulcerative colitis or Crohn’s disease; and Fresenius Kabi’s Otulfi which lacks the ulcerative colitis indication.

“[FDA approval is] an important milestone on our pathway to consistently broadening our biopharma portfolio in the US and worldwide.”

Commenting after the FDA approval was received, Fresenius Kabi’s president of biopharma Sang-Jin Pak said that the nod for the firm’s fourth US biosimilar – after Idacio (adalimumab-aacf), Tyenne (tocilizumab-aazg) and Stimufend (pegfilgrastim-fpgk) – represented “an important milestone on our pathway to consistently broadening our biopharma portfolio in the US and worldwide.”

“In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally,” Pak underlined.

Meanwhile, Formycon CEO Stefan Glombitza said the firm was “very proud of achieving this milestone in line with our plans,” indicating that the approval “exemplifies Formycon’s technical expertise and capabilities in developing high-quality, safe and affordable biologics.”

“Particularly in the area of chronic inflammatory diseases, only a limited number of patients worldwide have access to biologic therapies or often have to wait for years to receive this highly effective treatment,” Glombitza underlined, insisting that “it is important to us to improve access to biosimilars as quickly and broadly as possible.”

“Beyond that, FYB202 represents a key pillar of Formycon’s commercial and financial development going forward,” Glombitza added. “In this context, we are very pleased with the settlement, as it allows our biosimilar to enter the market earlier than previously announced, improving our competitive positioning even further.”

And Formycon chief financial officer Enno Spillner described the FDA approval as “an important step on our path to sustainable profitability, since FYB202 will contribute strongly to the financial strength of Formycon. We are pleased that with the recent approval decisions of the European Commission and the FDA, we have now successfully completed the formal approval process of FYB202 for the major markets.”

On the subject of a potential European launch date, the firms pointed to a recent settlement covering Europe and Canada but indicated only that “terms of the agreement are confidential.” (Also see "Fresenius And Formycon Strike Stelara Settlement For Europe And Canada" - Generics Bulletin, 19 Mar, 2024.)

Stelara biosimilars have already hit Europe in 2024, with Stada launching its Alvotech-partnered Uzpruvo version in late July, followed just days afterwards by Sandoz with its Samsung-Bioepis-developed Pyzchiva product. (Also see "And They’re Off! First Stelara Biosimilar Enters European Markets" - Generics Bulletin, 22 Jul, 2024.) (Also see "Second European Stelara Biosimilar Pits Sandoz Against Stada" - Generics Bulletin, 25 Jul, 2024.)