Biosimilar Regulatory Updates

Celltrion Submits BLA for Tocilizumab Biosimilar

On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar.  CT-P47 references Genentech’s ACTEMRA, an interleukin 6 receptor antagonist indicated for adult rheumatoid arthritis, juvenile idiopathic polyarthritis, and systemic juvenile idiopathic arthritis.  Celltrion’s Chief Commercial Officer, Thomas Nusbickel, said “[t]he submission of CT-P47 for review is an important step toward providing patients with rheumatoid arthritis a more accessible avenue to treatment for conditions that present such a significant disease burden.”  Celltrion’s BLA for CT-P47 is the third reported BLA for a tocilizumab biosimilar, following applications by Fresenius Kabi and Biogen, the latter of which was approved in September 2023.


FDA Accepts Accord BioPharma’s BLA for Ustekinumab Biosimilar

On January 4, 2024, Accord BioPharma, Inc. (“Accord”) announced that the FDA has accepted for review a BLA for DMB-3115, a biosimilar candidate to Janssen’s STELARA (ustekinumab). STELARA is approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.  DMB-3115 was developed jointly with Dong-A Socio Holdings and Meiji Seika Pharma., with exclusive commercialization rights granted to Intas Pharmaceuticals. Accord, a global subsidiary of Intas Pharmaceuticals, will be responsible for U.S. commercialization.  In October 2023, Accord settled with Janssen Biotech under confidential terms that would allow Accord to launch its proposed ustekinumab biosimilar no later than May 15, 2025, pending FDA approval.


EMA Accepts Formycon’s MAA for Aflibercept Biosimilar

On December 27, 2023, Formycon and its license partner Klinge Biopharma GmbH announced that the European Medicines Agency (“EMA”) has accepted for review its Marketing Authorization Application (“MAA”) for FYB203, a biosimilar candidate to Regeneron’s EYLEA.  Aflibercept is used in the treatment of neovascular age-related macular degeneration and other retinal diseases.  “With the recent EMA acceptance for our ophthalmological biosimilar candidate FYB203, we are an important step closer to providing another effective treatment option – in addition to our already launched biosimilar FYB201 (ranibizumab) – to the many patients affected by severe retinal diseases in Europe,” said Formycon CEO Dr. Stefan Glombitza.  As we previously reported, Formycon’s aBLA for FYB203 was accepted for review by the FDA in August 2023.