The Therapeutic Goods Administration (TGA) authorised the drug for eight inflammatory conditions: rheumatoid arthritis; psoriatic arthritis; ankylosing spondylitis; adult and paediatric Crohn's disease; refractory fistulising Crohn's disease; adult and paediatric ulcerative colitis; and plaque psoriasis.
Remicade patent
Inflectra is a rival to originator biologic Remicade, which is sold by Janssen in the US and by Merck & Co. in most of the rest of the world. Remicade cost the Australian government more than AUS$100m (US$73m) last year. Its patent expired in Australia this month.
“The new government has made it a priority to use biosimilars as they acknowledge that the cost of biologics is going to be significant burden on drug cost,” Frost & Sullivan’s Australia and New Zealand director Maz Khan told BioPharma-Reporter.com.
“Biosimilars can save over AUS$800m (US$585m) over the next four years. This is a significant saving for Australia.
“With Pfizer's acquisition of Hospira, and Sandoz with Novartis, we will see more and more biosimilars entering in Australia.”
Naming rules
Under TGA rules, biosimilar names are made up of the reference product’s Australian Biologic Name, followed by the prefix sim(a) and a three-letter International Nonproprietary Name (INN). The national regulator has adopted the same protocols for biosimilar safety and efficacy evaluation as the European Medicines Agency (EMA).
Australia already has nine non-mAb biosimilars on the market, approving the first, Sandoz’s Azicrit (epoetin lmbda) in 2010.
Other approved biosimilars are Sandoz’s Grandicrit (epoetin lmbda), Omnitrope (somatropin), and Zarzio (filgrastin); Eli Lilly’s Basglar (insulin glargine); Hospira’s Nivestim (filgrastin); Novartis’ Novicrit (epoetin lmbda); SciGen’s SciTropin A (somatropin); and Aspen’s Tervagratim (filgrastin).
‘Not a lucrative market’
Although Remicade came off patent only recently, Frost & Sullivan healthcare consultant Sanjeev Kumar told us there are several other reasons why Australia lags behind equally rich countries in launching biosimilars.
“Firstly, Australia is a relatively small pharmaceutical market. Despite having a good track record in biomedical research and a sound reputation in producing high quality biological pharmaceuticals, the country has a small generic and biosimilar medicine market. This is not very lucrative for the big pharmaceutical companies.”
He added Australia’s reimbursement and funding rules do not allow pharmacists to freely substitute originator biologics with biosimilars. However, the national government is reviewing the regulation and has begun several programmes to lower the public costs of generics and biosimilars as it gears up to promote these cheaper drugs.
Pfizer takeover
Inflectra launched in February 2015, around the time Pfizer agreed to purchase Hospira for US$17bn. The European Commission has since ordered Pfizer to divest its own biosimilar infliximab candidate to avoid anti-trust conflict with Hospira’s drug.
Inflectra was originally developed by South Korean company Celltrion, which in 2009 agreed to partner with Hospira on distribution. Hospira currently has exclusive rights to market the drug in Australia, New Zealand, Brazil, Mexico, the US, Canada, and several European countries.