Icelandic biosimilar manufacturer Alvotech announced on 15 June 2021 the completion of its switching study for AVT02, a biosimilar to adalimumab. Adalimumab is a monoclonal antibody that targets the inflammatory molecule tumour necrosis factor alpha (TNF-alpha) and can be used to treat several conditions including inflammatory bowel disease, rheumatoid arthritis and ankylosing spondylitis. It is sold under the brand name Humira by originator firm AbbVie.

Alvotech’s switching study aims to support the approval of AVT02 as an interchangeable biosimilar in the US, to be interchangeable with high concentration (100 mg/mL) forms of Humira. Interchangeable biosimilars can be substituted at the pharmacy level (without the approval of the prescribing physician), in a landmark decision, the US Food and Drug Administration (FDA) announced on 28 July 2021 that it had approved insulin glargine biosimilar Semglee (insulin glargine-yfgn) as the first interchangeable biosimilar product approved in the US for the treatment of diabetes [1].

The study is a multicentre, randomized, double-blind study which will assess pharmacodynamics, efficacy, safety and immunogenicity differences between patients receiving originator adalimumab (Humira) and patients undergoing repeated switches between Humira and AVT02. It includes 568 participants.
 
FDA accepted Alvotech’s submission for AVT02 in November 2020 and a decision regarding the Biologics License Application (BLA) is expected in September 2021 [2]. The final data have been collected for the primary outcome measures of the switching study and results are expected later in 2021.

CEO of Alvotech Mark Levick commented: ‘The completion of the comparative treatment phase of the switching study is a key milestone in our program for our AVT02 interchangeable biosimilar candidate. Achieving interchangeability in the U.S. is a cornerstone in our development strategy and consistent with our commitment to patients’.

In related news, Celltrion, which is headquartered in South Korea, recently presented data on their rituximab biosimilar (Truxima, also known as CT-P10) at the European Haematology Association 2021 Virtual Congress. Rituximab is a monoclonal antibody treatment for autoimmune disease and some types of cancer, including lymphomas. It is sold as Rituxan by originator firm Roche/Genentech.

The data presented came from a multi-country retrospective post-approval study, which investigated the safety and efficacy of Truxima in patients with diffuse large B-cell lymphoma (DLBCL, the most common type of non-Hodgkin’s lymphoma) in a real-world setting.

Data were collected from hospital medical records for patients with DLBCL who received treatment with Truxima in five European countries (France, Germany, Italy, Spain and the UK). The results showed that at 30 months, 67% of patients taking Truxima had not experienced disease progression, with 74% overall survival. Over 75% of patients initiated on Truxima achieved complete or partial response by 30 months. Truxima was also well tolerated, with adverse events statistically similar to those reported for the reference product.

Dr Mark Bishton, Consultant Haematologist at the University of Nottingham in the UK, said: ‘This is the first multi-country retrospective post-approval study to investigate the effectiveness and safety of CT-P10 treatment in patients with DLBCL in a real-world setting across Europe […] The response rates, survival rates and overall safety profile for CT-P10 appears consistent with those reported for reference rituximab, which could support the use of CT-P10 in combination with chemotherapy as a therapeutic option for DLBCL’.

Celltrion also presented data on rapid infusion of Truxima in patients with non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia. The results suggest that rapid infusion is generally well tolerated. Ten per cent of patients experienced an infusion-related reaction, which was most commonly fatigue, followed by nausea and vomiting.

‘The recommended protocol for rituximab infusion in Europe is a slow initial infusion rate with a gradual upward titration. Rapid infusion is often used in subsequent infusions for patients who had no serious complications related to the first infusion. We are encouraged by the results of the study as Truxima has demonstrated a similar IRR rate to reference rituximab. This will allow informed, evidence-based decisions on cost-effective treatment strategy for patients with CLL or NHL’, said Dr HoUng Kim, PhD, Head of Medical and Marketing Division at Celltrion Healthcare.

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References
1. GaBI Online - Generics and Biosimilars Initiative. FDA approves first interchangeable insulin glargine biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Aug 27]. Available from: www.gabionline.net/biosimilars/news/fda-approves-first-interchangeable-insulin-glargine-biosimilar 
2. GaBI Online - Generics and Biosimilars Initiative. EMA and FDA accept application for adalimumab biosimilar AVT02 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Aug 27]. Available from: www.gabionline.net/biosimilars/news/EMA-and-FDA-accept-application-for-adalimumab-biosimilar-AVT02

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