Celltrion seeks Cosentyx biosimilar approval without pediatric indication

Adult hidradenitis suppurativa indication also excluded…focuses only on core adult indications

Aims for market launch immediately after composition patent expiry through patent circumvention

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Celltrion has adopted an “independent strategy” to circumvent the original drug’s exclusivity as it prepares to launch a biosimilar of the blockbuster autoimmune disease therapy, Cosentyx (secukinumab), in Korea.

Rather than seeking approval for all of the original Cosentyx's approved indications, the company has applied only for the core adult indications, excluding pediatric indications and hidradenitis suppurativa (HS).

According to the Ministry of Food and Drug Safety (MFDS), a marketing authorization application for a secukinumab biosimilar that references Cosentyx products registered in Korea (Cosentyx SensoReady Pen and Cosentyx Prefilled Syringe, etc) was submitted on June 26. The reference product is believed to be a Cosentyx biosimilar in development by Celltrion.

A notable aspect of the filing is Celltrion's move immediately prior to the application. On June 25, one day before submitting its application, Celltrion filed a scope confirmation trial with the Patent Court against Novartis, the holder of Cosentyx's patents.

The move is viewed as a strategic step to secure first generic exclusivity under Korea's drug approval-patent linkage system. To obtain an exclusive sales period for a biosimilar, a company must both be the ‘first to challenge the patent’ and be the ‘first to submit a marketing authorization application.’

The most notable aspect is the company’s decision to omit several of the original drug’s approved indications. The original Cosentyx is approved for adults with plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and hidradenitis suppurativa, as well as for pediatric plaque psoriasis and juvenile idiopathic arthritis.

However, the biosimilar application includes only three core adult indications: ▲Plaque psoriasis, ▲Psoriatic arthritis, and ▲Axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis). The application excludes adult hidradenitis suppurativa and all pediatric indications of the original drug.

The move is regarded as an effort to avoid the original drug's remaining patents. The hidradenitis suppurativa and pediatric indications were added relatively recently, meaning their re-examination periods or patent terms still have considerable time remaining. Celltrion therefore appears to have opted to target the core adult indications that would enable the earliest market entry in Korea.

Instead of seeking approval for a broader range of indications, Celltrion is taking the remaining key patents head-on. The patents Celltrion challenged on June 25 are Cosentyx's core patents.

Cosentyx currently holds a method-of-use patent for the "treatment of psoriasis using an IL-17 antagonist," which is set to expire on October 7, 2031, and a formulation patent for "pharmaceutical products and stable liquid formulations of IL-17 antibodies," which is set to expire on December 21, 2035.

In particular, the liquid formulation patent expiring in 2035 is considered a barrier that must be overcome to produce an injectable biosimilar. Through the scope confirmation trial, Celltrion plans to focus on demonstrating that its independently developed protein composition and formulation technology do not fall within the scope of the original drug’s patent.

An industry official said, "Celltrion's application filing suggests that it intends to work around the patents essential to launching the product (psoriasis treatment method and formulation patents) through the patent trial, and launch the product immediately after the original’s substance patent expires on February 27, 2028, in an effort to gain a first-mover advantage in the Korean market."