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Second infliximab biosimilar to be launched in Australia in 2Q 2017 Posted 12/05/2017

Merck Sharp and Dohme (MSD) announced on 1 May 2017 its intention to launch the infliximab biosimilar Renflexis in the second half of 2017.

Renflexis received Therapeutic Goods Administration (TGA) approval on 28 November 2016 [1]. The company has also applied for listing on the Australian Pharmaceutical Benefits Scheme (PBS) and in its recommendation the Pharmaceutical Benefits Advisory Committee (PBAC) said that Remicade and Renflexis ‘could be marked as equivalent in the Schedule of Pharmaceutical Benefits (‘a’ flagged) for the purposes of substitution by the pharmacist at the point of dispensing for all indications currently PBS-listed’.

Infliximab is a chimeric monoclonal antibody against tumour necrosis factor alpha (TNF-α). It is used to treat autoimmune diseases, such as ankylosing spondylitis, Crohn’s disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. 

Renflexis is the second infliximab biosimilar to receive TGA approval. Hospira’s infliximab biosimilar, Inflectra, received approval in Australia on 19 August 2015 [1]. Despite this approval, public hospital spending on infliximab in Australia remains high and was AU$82.5 million for 2015−16. In fact, the drug remains the most costly therapy on the Highly Specialised Drug Program dispensed via public hospitals. 

MSD Medical Director Dr Gary Jankelowitz said the company, and its partner, Samsung Bioepis, were focused on bringing Renflexis to the Australian market at the earliest opportunity. 

The biosimilar was also approved in the European Union, where it is called Flixabi, in May 2016 [2] and in South Korea as Renflexis in December 2015 [3]. Renflexis was approved by the US Food and Drug Administration (FDA) with the non-proprietary name infliximab-abda in April 2017 [4].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 12]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Australia
2. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of infliximab biosimilar Flixabi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 12]. Available from: www.gabionline.net/Biosimilars/News/EMA-recommends-approval-of-infliximab-biosimilar-Flixabi
3. GaBI Online - Generics and Biosimilars Initiative. Korean approval for infliximab biosimilar [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 12]. Available from: www.gabionline.net/Biosimilars/News/Korean-approval-for-infliximab-biosimilar
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilar infliximab Renflexis [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 May 12]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-biosimilar-infliximab-Renflexis

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Source: PBAC,PBS

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