In early trial, AVT05 shows similar pharmacological profile to Simponi

Biosimilar candidate intended to help increase treatment access and lower costs

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by Andrea Lobo |

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AVT05, Alvotech’s biosimilar candidate to treat ankylosing spondylitis (AS) and other chronic inflammatory diseases, showed a similar pharmacological profile to the reference medication Simponi (golimumab) in a clinical trial.

The Phase 1 trial (NCT05632211) compared the safety, tolerability, and pharmacokinetics — movement into, through, and out of the body — of the two medications in 336 healthy participants. Both were given at a single dose of 50 milligrams in a 0.5 mL pre-filled syringe, via a subcutaneous (under-the-skin) injection into the thigh or abdomen.

The trial launched in January, and was conducted in New Zealand and the U.K.

“These results demonstrate the strength of our platform approach to biosimilars development and manufacture, combining a well-designed and executed clinical study with the design of a high-quality manufacturing process and strong analytical capabilities,” Joseph McClellan, PhD, Alvotech’s chief scientific officer, said in a company press release.

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Simponi an antibody designed to bind to, block TNF-alpha protein

Janssen’s Simponi, also available as Simponi Aria, is an antibody designed to bind to and block the tumor necrosis factor (TNF)-alpha protein, which is involved in excessive inflammation associated with several autoimmune diseases.

The medication is approved for the treatment of AS and other inflammatory conditions such as rheumatoid arthritis and psoriatic arthritis. By blocking TNF-alpha, Simponi is intended to ease inflammation and disease symptoms.

If AVT05 is shown to be equally as safe and effective as Simponi when administered in the same way and at the same dose, it may be approved and offered at a lower price than its reference medicine. Like generic medicines, biosimilars aim to ease treatment costs and improve access to medicines.

Moreover, Alvotech is conducting the ALVOFLEX Phase 3 clinical study (NCT05842213) comparing the efficacy, safety, and immunogenicity, which is the ability to induce an immune response, of AVT05 and Simponi in combination with the immune system suppressant methotrexate in adults with moderate to severe rheumatoid arthritis.

The primary outcome is to demonstrate the comparative efficacy of AVT05 and Simponi, based on changes in the 28-joint Disease Activity Score (DAS28-CRP), which assesses rheumatoid arthritis severity using clinical and laboratory data.

So far, the trial has recruited 502 participants at a site in Bulgaria. The study is expected to be completed by August 2024.

“As we progress more biosimilar candidates through clinical development and approval, we continue to reaffirm our commitment to improving patient lives by expanding access to affordable biologics,” McClellan said.