Secukinumab, an IL-17A antagonist, is marketed by Novartis under the brand name Cosentyx®. In 2023, Cosentyx® observed the sales of 5 billion dollars, inclusive of US market, EU member states, Japan, and other emerging markets. However, there was a small decline observed in the US market due to higher revenue deductions. The drug has been approved for various autoimmune conditions such as plaque psoriasis, active psoriatic arthritis, ankylosing spondylitis, active non-radiographic axial spondyloarthritis, active enthesitis-related arthritis, and more recently for moderate to severe hidradenitis suppurativa (HS). The approval for HS makes the drug the first treatment option to treat HS in nearly a decade. Novartis is further innovating by conducting phase 3 clinical trials for Cosentyx® for giant cell Arteritis, polymyalgia rheumatica, and rotator cuff tendinopathy in 2024 and plan to submit applications for supplementary indications by 2025 and 2026.

Cosentyx® was approved in January 2015 in the US and the European Union (EU). Since the approval in the US, it enjoys a biosimilar application submission exclusivity (BASE) until 2025 and biosimilar application approval exclusivity (BAAE) until 2027 i.e. biosimilar manufacturers would not be able to get biosimilar applications approved in the US until 2027. The US patent US7808155 that protects Secukinumab molecule expires in May 2027 but it has been granted a patent term extension (PTE) of 1013 days and so now expires in February 2030. In the EU, the regulatory data exclusivity period is set to expire in 2025. There are patent term extensions granted on EP1776142 in member states such as Great Britain, France, Spain and more that are set to expire in January 2030 with a paediatric extension (for psoriasis) expiring in July 2030. This paediatric approval is based on two phase 3 studies in children and adolescents aged six to <18 years. In both studies, low-dose (75–150 mg) and high-dose (75–300 mg) Cosentyx® was effective in rapidly improving skin symptoms and quality of life. In Japan, there are multiple patent term extensions granted on patents protecting the molecule that expire beyond 2030.

Currently, Cosentyx® is not threatened by the biosimilar competition in the market. However, that does not mean that there is no competition underway. Several biosimilar candidates are under different stages of clinical trials with most of them under development in the China market, as follows:

Along the way, Cosentyx® is fighting off competition from Lilly’s Taltz®. Both drugs are IL-17A inhibitors. Taltz®, although a blockbuster drug in its own right, is so far no match to Cosentyx®. Eli Lilly and Novartis are in the midst of a complex European patent and competition (antitrust) litigation regarding their competing monoclonal antibody drugs used to treat autoimmune symptoms such as psoriasis and arthritis.  The cases are pending in Ireland, Italy, and Austria; with a German action already settled.  In each of these cases, Novartis is the plaintiff asserting patent infringement. One quirk is that the Novartis patents were not developed alongside the company’s Cosentyx® product. Rather, Genentech held the patents and was actually looking to enforce them against both Novartis and Lilly. In 2019/2020, Novartis purchased the portfolio from Genentech, took over the prosecution of the pending cases (including some US applications) and started its enforcement campaign.

Lilly has argued that Novartis’ approach violates European competition laws. Part of what is going on is that Novartis was trying to challenge the patents when they were held by Genentech, arguing invalidity at the time. Novartis changed its tune once it became the owner. In order to build its case, Lilly wants Novartis to turn-over its internal documents relating to its prior-opposition and subsequent purchase of the patents, including the actual purchase agreement.

With that, it is also expected that Cosentyx® be a part of the Inflation Reduction Act (IRA) negotiation lists by 2028. However, it will be interesting to see how it makes it to the list or will that be prevented due to biosimilar market entries.