Hadlima is a biosimilar to AbbVie’s Humira (adalimumab), which had worldwide sales of US$18.4 billion in 2017. Adalimumab is a human monoclonal antibody that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF), a soluble inflammatory cytokine. Adalimumab binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Adalimumab is indicated for the treatment of rheumatoid, juvenile idiopathic and psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis and ulcerative colitis.

Hadlima received approval from Australia’s drug regulatory body, the Therapeutic Goods Administration (TGA), in January 2018. It is the third biosimilar Samsung Bioepis has launched in Australia. The company also markets an etanercept biosimilar, Brenzys, and an infliximab biosimilar, Renflexis, in the country, which received approval from the TGA in 2016 and 2017, respectively [1].

Hadlima was listed on the Australian Pharmaceutical Benefits Scheme (PBS) on 1 April 2021, along with three other adalimumab biosimilars, Amgevita, Hyrimoz and Idacio. Under the PBS, the Australian Government subsidizes the cost of medicine for most medical conditions.

Australia’s PBS is encouraging the use of biosimilars with its Biosimilar Awareness Initiative, which is intended to support awareness of, and confidence in, the use of biosimilar medicines for healthcare professionals and consumers. The Australian Government is also implementing two specific drivers to encourage the use of biosimilar medicines, which it believes will complement the Biosimilar Awareness Initiative. The two specific biosimilar uptake drivers being implemented are:

• encouraging prescribing of a biosimilar brand rather than the reference biological brand for treatment naïve patients.
• providing for a simpler and faster approval process for prescribing biosimilar brands, e.g. streamlined authority, while maintaining an existing higher level authority requirement for the reference biological brand, e.g. written authority.

Samsung Bioepis says that Hadlima is now available in three markets: Europe, Canada and Australia. It was first launched in Europe in October 2018 under the name Imraldi in partnership with Biogen. Then in February 2021 it was launched in Canada in partnership with Merck (known as MSD outside of the US and Canada). The company also received approval for Hadlima from the US Food and Drug Administration in July 2019 [2].

Related articles
Biosimilars in Australia – a-flagging and sustainability

Biosimilar advances for Samsung Bioepis

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Australia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 May 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Australia 
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves adalimumab biosimilar Hadlima [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021May 7]. Available from: www.gabionline.net/Biosimilars/News/FDA-approves-adalimumab-biosimilar-Hadlima

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