AVT02, an Humira Biosimilar, Approved in Australia to Treat AS

Therapy, under review in US, to be marketed there as Ciptune and Ardalicip

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by Andrea Lobo |

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An illustration marking a regulatory approval.

AVT02, a high-concentration and low-volume biosimilar to AbbVie’s Humira (adalimumab), was approved by health regulators in Australia to treat inflammatory disorders such as ankylosing spondylitis (AS).

A biosimilar is a biological medicine with a high degree of similarity — in terms of quality, safety, and efficacy — to a previously approved, brand-name therapy. Biosimilars are typically available at lower prices than their reference medication.

Developed by Alvotech, AVT02 will be marketed in Australia by Cipla as Ciptune and Ardalicip. The biosimilar will be available as a pre-filled syringe (at a dose of 40 mg in a 0.4 mL solution or 80 mg in a 0.8 mL solution) and a pre-filled pen (40 mg/0.4 mL solution) for greater ease of use, an Alvotech press release reported.

This approval is expected to improve treatment availability and affordability for patients in that country.

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Like Humira, AVT02 is a anti-tumor necrosis factor (TNF) treatment

AVT02 is approved in Europe under the name Hukyundra, and in Canada and Saudi Arabia as Simlandi. Similar regulatory applications are under review in several countries, including the U.S., where it was accepted for review in late 2020.

After an inspection to Alvotech’s manufacturing facilities in Reykjavik, Iceland, earlier this year, the U.S. Food and Drug Administration noted certain deficiencies that need to be resolved before the therapy might be approved. A decision is expected in December.

“We are very pleased about the marketing authorization in Australia, following approval and successful launches of Alvotech’s high concentration biosimilar to Humira in multiple markets in Europe and Canada,” said Mark Levick, CEO of Alvotech.

Ankylosing spondylitis is a type of arthritis characterized mainly by inflammation in the joints of the spine.

Anti-tumor necrosis factor (TNF) medications, which work by blocking the activity of the pro-inflammatory molecule TNF, are effective in treating AS symptoms. Higher levels of TNF can exacerbate inflammation and contribute to disease symptoms.

AVT02, like Humira, is an antibody that blocks TNF activity.

Its approvals were based on results from two clinical trials comparing the biosimilar to Humira: a Phase 1 study (NCT03849313) in healthy adults and a Phase 3 trial (NCT03849404) in people with chronic psoriasis, an inflammatory disease affecting the skin.

Humira biosimilars are expected to enter U.S. market in 2023

AVT02 is the first approved biosimilar under the partnership between Alvotech and Cipla, which was announced in July 2019 for the commercialization of AVT02 in select markets.

Under this partnership, Alvotech will be responsible for the development and supply of AVT02, while Cipla will be responsible for the registration and commercialization of the medication.

The partnership was extended to South Africa in November 2020, and to Australia and New Zealand in January 2021 for other biosimilar candidates developed by Alvotech.

“The first approved biosimilar in Cipla’s partnership with Alvotech marks an important milestone,” said Nishant Saxena, Cipla’s CEO of international business (Europe and emerging markets).

“We look forward to extending our footprint in the biosimilars market by increasing the availability of cost-effective high-concentration low-volume adalimumab for Australian patients,” Saxena added.

Other Humira biosimilars, such as Cyltezo, Hulio, and Hadlima, are approved in the U.S. to manage AS symptoms. However, due to Humira’s patent protections, they will not be commercially available in the U.S. until 2023.