Eye on Pharma: Natalizumab Injunction; Oral Ustekinumab Development; New Study for Secukinumab Biosimilar

As the rest of the biosimilar industry prepares for adalimumab biosimilars to launch in the United States next year, Biogen announces an injunction against Sandoz over a natalizumab biosimilar, Rani Therapeutics initiates a development program for an oral ustekinumab biosimilar, and Bio-Thera Solutions begins a phase 3 trial for a secukinumab biosimilar.

Natalizumab Biosimilar Injunction

According to a report from Big Molecule Watch, Biogen is seeking a preliminary injunction in its Biologics Price Competition and Innovation Act (BPCIA) lawsuit against Sandoz. The case is related to Sandoz’ proposed biosimilar of Tysabri (natalizumab), a drug used to treat Crohn disease and multiple sclerosis.

Biogen’s motion will be completed by April 7, 2023, and a hearing is scheduled shortly after at the Court’s discretion. The company has also filed a redacted version of its 107-page sealed complaint against Sandoz, in which Biogen alleges that Sandoz has infringed 28 patents protected under the BPCIA in it biologics license application of PB006, its natalizumab biosimilar candidate.

Representatives from Biogen said the asserted patents are related to “inventions relating to Tysabri, including regarding therapeutic uses of Tysabri, ways of making treatment with Tysabri safer for patients and Biogen’s innovative methods of manufacturing antibodies, such as Tysabri.”

Oral Ustekinumab Biosimilar Development

Rani Therapeutics, a clinical stage biotherapeutics company based in California, announced that it has started the preclinical development process for RT-111, a RaniPill GO capsule using an ustekinumab biosimilar.

The biosimilar references Stelara, which is used to treat moderate to severe plaque psoriasis, active psoriatic arthritis, moderate to severe Crohn disease, and moderate to severe ulcerative colitis, all of which have an unmet need for oral therapies.

“Ustekinumab has helped thousands of patients with inflammatory autoimmune diseases, but today the treatment requires regular long-term injections. Rani is developing RT-111, an orally administered ustekinumab biosimilar, with the goal of reducing the burden of treatment and improving outcomes for patients. We are increasingly excited about the potential of the RaniPill platform to provide patients with oral replacements to current injectable standards of care, and we expect that RT-111 will be the first of many expansions of our pipeline,” said Talat Imran, CEO of Rani Therapeutics in a company statement.

Rani Therapeutics has developed and tested the RaniPill capsule, an oral delivery platform that can administer any drug, including large molecules, such as peptides, proteins, and antibodies. The RaniPill Go can deliver up to 3 mg of a drug with high bioavailability. Rani Therapeutics is also working on a high-capacity RaniPill device (RaniPill HC) that can deliver payloads of up to 20 mg with high bioavailability.

Phase 3 Trial for Secukinumab Biosimilar

Bio-Thera Solutions shared that it had initiated a phase 3 trial for its secukinumab biosimilar candidate (BAT2306) that references Cosentyx. The randomized, double-blind, parallel group, active control study will compare the efficacy and safety of the biosimilar and the reference product in patients with moderate to severe plaque psoriasis.

Secukinumab is a human immunoglobulin G1k monoclonal antibody that binds to interleukin-17A. Cosentyx is used in the treatment of adult and pediatric patients with plaque psoriasis, active enthesitis-related arthritis, and active psoriatic arthritis. It’s also indicated for treating adult patients with active nonradiographic axial spondyloarthritis and active ankylosing spondylitis.

Bio-Thera said that after the trial is completed, it will file for regulatory approval for all indications of the reference product in the European Union, United Kingdom, China, and United States. In addition to BAT2306, Bio-Thera is developing biosimilars referencing Actemra (tocilizumab), Simponi (golimumab), Stelara, and Nucala (mepolizumab). Qletli, a biosimilar referencing Humira (adalimumab), and Pobevcy, a biosimilar for Avastin (bevacizumab), have been approved and are marketed in China.