Sandoz’ applications for its Tysabri biosimilar (natalizumab) and its high-concentration version of its Humira biosimilar (adalimumab) were accepted for review by the FDA and the European Medicines Agency.
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.
Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market
May 8th 2024Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment
May 4th 2024A review article summarizes the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.
Biosimilars Rheumatology Roundup for February 2024—Podcast Edition
March 3rd 2024On this episode of Not So Different, The Center for Biosimilars® revisited all the major rheumatology biosimilar news from February 2024, including the FDA approval of the 10th adalimumab biosimilar, the promise for an oral delivery system for ustekinumab, and the impact of adalimumab products on COVID-19 antibodies.
Eye on Pharma: EU Ustekinumab Approval; New Golimumab Data; Evernorth Adds Humira Biosimilar
April 29th 2024The European Union gained a new ustekinumab biosimilar; Alvotech released positive results from a clinical trial evaluating a golimumab biosimilar and the reference products (Simponi and Simponi Aria), and Evernorth announced that it is set to cover an adalimumab biosimilar at zero cost to patients.