Alvotech Launches Study of Simponi Biosimilar in Healthy Volunteers

Phase 1 trial testing AVT05 as treatment for AS and other diseases

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by Margarida Maia PhD |

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Alvotech has launched a Phase 1 clinical trial to test the safety and efficacy of AVT05, its biosimilar drug candidate to Simponi (golimumab) — being developed for the treatment of ankylosing spondylitis (AS) and other diseases marked by inflammation.

The study (NCT05632211) is enrolling more than 330 healthy volunteers at a single site in New Zealand.

It will investigate AVT05 when given at a single dose of 50 milligrams via an injection under the skin (subcutaneously). The treatment will be injected into the thigh or abdomen using a pre-filled syringe containing 0.5 mL of the medication.

To be approved as a biosimilar, AVT05 must be shown to be as safe and effective as its reference medicine, Simponi, when administered in the same way and at the same dose as the original drug.

Thus, the trial will compare the two medications in healthy volunteers. In addition to safety and tolerability, it will investigate if the new biosimilar drug has a comparable pharmacokinetics profile to the original product. Pharmacokinetics refers to a drug’s movement into, through, and out of the body over time.

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Testing the safety of the biosimilar drug AVT05

“We are delighted with the progress of the AVT05 development program,” Joseph McClellan, PhD, Alvotech’s chief scientific officer, said in a company press release announcing the trial’s launch.

AS is a form of arthritis in which joints in the spine and other parts of the body become inflamed and stiff over time. While there is no cure for AS, treatments are available to ease its symptoms and slow the progression of the disease.

Janssen’s Simponi, also available as Simponi Aria, is an antibody-based medication designed to block the tumor necrosis factor (TNF) alpha protein, which is involved in the excess inflammation that drives a number of autoimmune diseases.

The medication is approved for AS, as well rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, a form of inflammatory bowel disease. By blocking TNF-alpha, Simponi is expected to reduce inflammation and ease the symptoms of these inflammatory conditions.

If data from the new clinical trial are positive and AVT05 is shown to be equally as safe and effective as Simponi, the biosimilar may be offered at a discount to its reference medicine. This is because, just like a generic medicine, a biosimilar aims to bring down treatment costs and improve access to medicines.

“As we enter our fifth biosimilar candidate into clinical studies, we reaffirm our commitment to improving patient lives by expanding access to affordable biologics,” McClellan said.