Uwe Gudat, M.D.: New Biosimilar Data Bring Reassurance for Patients With Psoriasis

Uwe Gudat, M.D.

Credit: Biocon Biologics

In an interview with The Educated Patient, Uwe Gudat, M.D., chief medical officer at Biocon Biologics, discusses the new phase 3 data presented at the European Academy of Dermatology and Venereology (EADV) 2024 Congress, which supported the biosimilarity and interchangeability for high- and low-concentration adalimumab-fkjp (Hulio) in patients with chronic plaque psoriasis and Bmab 1200 (bUstekinumab) in patients with moderate to severe chronic plaque psoriasis.

For those who may be unfamiliar, what does the term "biosimilar" mean, and how does it differ from the original treatment?

Uwe Gudat, M.D.: Some medicines have structures too complex to be created with conventional chemistry and are instead made using living cells with introduced genetic material. These are known as biologics. Unlike small-molecule drugs, biologics are not chemically identical batch to batch — each batch has slight natural variations, much like homemade bread made with yeast. The original biologic itself varies from batch to batch, and a “biosimilar” is a product made by another company that is just as similar to the original as the original batches were to each other. Clinically, biosimilars and their originals are equivalent.

Can you explain the term "interchangeability" and why it matters for patients with psoriasis who are switching medications?

UG: Interchangeability confirms that the products can be readily exchanged or interchanged. Going from one to the other and back has no clinical impact. This reassures patients who may wish to take one or the other original or biosimilar.

What were the key findings of the study determining the interchangeability between high-concentration adalimumab and the low-concentration biosimilar version (adalimumab-fkjp)?

UG: When the regulatory pathway for biosimilars was first developed, there were concerns as to whether prior exposure to a biosimilar would somehow adversely affect the response to the original. In order to give greater confidence that this was not the case, additional evidence was required by the U.S. Food and Drug Administration (FDA). This generally involved a study in which patients were switched back and forth between the original and the biosimilar to see whether that would change the treatment response. The key finding of the study is that exchanging original and biosimilar does not change the treatment response.

The study also showed that at dose parity, dosing of a less or more concentrated formulation of the biologics leads to the same exposure in patients. Thus, in terms of clinical efficacy and safety, which are a function of exposure, no differences between the two formulations can be expected. This means that either formulation can be used to achieve the same results.

What did the results of the study evaluating biosimilarity between ustekinumab and the biosimilar Bmab 1200 (bUstekinumab) reveal?

UG: This is an important study that provided two distinct threads of information. Firstly, exposure over time that is the pharmacokinetic profile of the original and the Bmab 1200 were the same. Thus, the actions of the body on the drug did not differ. Secondly, the actions of the drug on the body in terms of its propensity to stimulate antidrug antibodies also did not differ. This study in health volunteers provides a valuable global assay of clinical similarity, confirming that interactions between the drug and body did not differ notably.

How will these new findings affect treatment options and what patients should discuss with their dermatologist?

UG: Biosimilars offer a unique value proposition, merging quality with an attractive price. The greater affordability benefits patients directly by allowing for greater access and indirectly by supporting the sustainability of healthcare systems they rely on.

What do these new findings mean for long-term treatment and management of chronic plaque psoriasis?

UG: More patients can with confidence more readily receive state-of-the-art treatments, adding to quality of life and treatment satisfaction.

Is there anything else you would like our audience to know?

UG: Embracing the biosimilar offering is an opportunity for patients and for creating a sustainable healthcare system through directly facilitating and securing patients’ long-term access to life-changing therapeutics and also indirectly as patients benefit from more affordable treatments that contribute to the sustainability of our health care systems.