Clinical study advances for Alvotech golimumab and Dr Reddy’s rituximab biosimilars

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Clinical study advances for Alvotech golimumab and Dr Reddy’s rituximab biosimilars

Biosimilars/News | Posted 03/02/2023 0

In January 2023, Alvotech announced that it has initiated a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab). In addition, Dr Reddy’s Laboratories Ltd announced the successful completion of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI. This is now ready for filing in markets such as the US and Europe.

Golimumab is a monoclonal antibody that targets the inflammatory molecule tumour necrosis factor-alpha (TNF-alpha). It can be used in the treatment of inflammatory conditions including rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis and is sold under the brand name Simponi by originator company Janssen [1].

The originator product, Janssen Biotech’s Simponi (golimumab), was approved by the US Food and Drug Administration (FDA) on 24 April 2009 and by the European Medicines Agency (EMA) on 1 October 2009 [2].

AVT05 is a biosimilar candidate to golimumab and is yet to be approved in any country and the current trial will assess the pharmacokinetics, safety, and tolerability of AVT05 compared to the reference product in healthy adult subjects. This is Alvotech’s fifth biosimilar candidate to enter clinical trials.

Dr Reddy’s DRL_RI is being developed as a biosimilar of rituximab and with the successful completion of clinical studies for highly regulated markets, the company is now preparing to file Biologics License Application (BLA) and marketing authorisation application (MAA) dossiers.

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders [3]. The originator product, Roche’s MabThera/Rituxan (rituximab), was approved by FDA on 26 November 1997 and by EMA on 2 June 1998 [2].

Dr Reddy’s rituximab ‘similar biological’ has already been approved for marketing in India and over 25 emerging markets. The further clinical development and successful completion of the phase III trials means that the candidate now meets regulatory requirements of highly regulated markets. Dr Reddy’s is working with its partner Fresenius Kabi to commercialize rituximab in the US. It is also working to bring the product to market in Europe and other markets.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Clinical trials begin for Bio-Thera’s golimumab copy biological [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 3]. Available from: www.gabionline.net/biosimilars/research/clinical-trials-begin-for-bio-thera-s-golimumab-copy-biological
2. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of rituximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2023 Feb 3]. Available from: www.gabionline.net/biosimilars/general/Biosimilars-of-rituximab

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