Applications for Sandoz’ Tysabri, Humira Biosimilars Accepted for Review

Sandoz’ applications for 2 biosimilars were submitted and accepted for review in the United States and European Union.

The FDA and the European Medicines Agency (EMA) are reviewing a biologics license applications (BLA) and marketing authorization application (MAA), respectively, for a biosimilar referencing Tysabri (natalizumab) for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive disease in adult patients, as well as Crohn disease.

The applications is the first and only submission for a natalizumab biosimilar in the United States and Europe, according to Florian Bieber, global head of biopharmaceuticals development at Sandoz, which is owned by Novartis.

“Thanks to advances in medicine over the last 20 years, we now have [disease modifying therapies], which have become a cornerstone in the treatment of MS. However, access to affordable, high-quality treatment options is still a challenge…. If approved, this biosimilar has the potential to increase access while also delivering savings for healthcare systems,” said Bieber.

The biosimilar was developed by Polpharma Biologics and will commercialized by Sandoz in the United States and European Union. Polpharma Biologics is also responsible for the development, manufacturing, and supply of the biosimilar. Sandoz and Polpharma Biologics entered into an agreement in 2019.

The BLA and MAA contained data from the phase 1 study with healthy participants and a phase 3 study with patients with RRMS that showed that the biosimilar had comparable safety and efficacy to the reference product.

Additionally, the FDA is reviewing a supplemental BLA for a high-concentration, citrate-free (100 mg/mL) version of Hyrimoz (Hyrimoz HCF), Sandoz’ adalimumab biosimilar. The news comes shortly after the EMA also accepted an MAA for Hyrimoz HCF.

The application is seeking approval for Hyrimoz HCF for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, and plaque psoriasis.

“Should the Hyrimoz HCF be approved, we believe this important biosimilar medicine would help expand access to more patients with serious inflammatory diseases, including those who currently may not have access to it,” said Keren Haruvi, the president of Sandoz and head of the North America division, in a statement from Sandoz.

The original Hyrimoz formulation was approved by the FDA in November 2018 and is expected to enter the US market in September 2023. Because of AbbVie’s, the maker of Humira, extensive patent lawsuits and pay-for-delay agreements to prevent biosimilar competition, adalimumab biosimilar are not able to launch on the US market until 2023. The original Hyrimoz is slated to be the sixth adalimumab biosimilar to enter the market, with 1 more to follow in November 2023.

Although both of the high-concentration and low-concentration versions of Humira are available for US patients, over 80% of prescriptions are for the high-concentration solution. The high-concentration aspect of the product allows for reduction in the number of injections needed in some patients and the citrate-free feature offers patients less discomfort and injection-site pain while encouraging better adherence compared to the original, low-concentration formulation.