Expert: FDA Approves Tocilizumab-Anoh as a Biosimilar to Actemra

The FDA approved tocilizumab-anoh (Avtozma; Celltrion), a biosimilar to tocilizumab (Actemra; Genentech), as both an intravenous and subcutaneous formulation to treat multiple diseases, including rheumatoid arthritis (RA), giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and COVID-19. Tom Nusbickel, chief commercial officer at Celltrion USA discussed how tocilizumab-anoh is anticipated to increase competition, leading to greater accessibility and cost savings for health care systems and patients, in an interview with Pharmacy Times®.

Pharmacy Times

Can you explain "biosimilar" in the context of Avtozma and its importance?

Tom Nusbickel

Celltrion's Avtozma — that's our brand name, will be the third tocilizumab biosimilar approved in the US. It's been approved by the biosimilar pathway, so it's similar to other products that we've had approved in the US through this pathway. We expect that as we see an increase in the number of approved to tocilizumab biosimilars, we're expecting that there'll be increased savings and sustainability for health care systems and an increase in physician and patient access to biologics. We do have a patent settlement agreement, and we have a license to market Avtozma in the US once the license dates are in place, but these are confidential. For us, this adds another product to our growing immunology portfolio. We've already launched 2 versions of adalimumab and a novel, first in class products in zymfentra in the in the IBD space. We believe this just adds to what we offer to physicians and patients in the immunology side.

Pharmacy Times

What are some of the potential benefits of having a biosimilar version to tocilizumab?

Nusbickel

In general, this allows there to be competition within a class which hadn't had much competition previously, and that makes the products more accessible, potentially to more patients, because we're delivering high quality products at a lower cost to the health care system.

Pharmacy Times

Why did the phase 3 trial involve switching patients between treatments, and what does this tell us?

Nusbickel

We determined that, in general, we typically do in phase 3 trials, we just have to demonstrate that there's a therapeutic equivalence to the reference product. We did do a phase 3 study in which Avtozma demonstrated therapeutic equivalents to the reference tocilizumab, and the one-year results showed that Avtozma had comparable and sustained efficacy and safety compared with the reference tocilizumab, even after the switch We did determine that there was value in doing the switching study. So, we did do that as an additional study.

Pharmacy Times

This approval covers multiple inflammatory conditions beyond rheumatoid arthritis. Why is tocilizumab, and therefore Avtozma, effective in treating such a range of diseases?

Nusbickel

In biosimilarity in the US, once you've proved that you have biosimilarity, typically you have the approval to use the product and all the approved indications of the originator. We expect to have all the indications, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis, and coronavirus disease. Again, we’ve demonstrated that our product is highly similar to an already approved biologic product with no clinical meaningful difference and safety and efficacy from the reference product. Based on that, the FDA typically grants approval for all the indications of the reference product.

Pharmacy Times

Is there anything you would like to add?

Nusbickel

Celltrion is excited — as a fully integrated biopharmaceutical company, we have the ability to deliver on a pipeline and continue to make offerings that will continue to promote increased access for patients and important diseases at a reduced cost.