MSD has today announced the availability of biosimilar RENFLEXIS® (infliximab) on the Pharmaceutical Benefits Scheme (PBS) from 1st August1.
RENFLEXIS is the second infliximab biosimilar to be PBS listed. RENFLEXIS is indicated for the treatment of moderate to severe Crohn's disease and moderately severe to severe ulcerative colitis in adults and in children adolescents (6 to 17 years) who have had an inadequate response to conventional therapies2. RENFLEXIS is also indicated, in adults, for the treatment of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, moderate to severe psoriasis and refractory fistulising Crohn's disease2. RENFLEXIS should be given in combination with methotrexate for the treatment of rheumatoid arthritis, and alone, or in combination with methotrexate, for the treatment of psoriatic arthritis2.
Dr Gregory Moore, chair of the Australian Inflammatory Bowel Disease Association, said new biosimilar options are giving prescribers more choice and contributing to broader cost-effectiveness.
"Australian Gastroenterologists welcome the addition of biosimilar infliximab to the Australian market. These rigorously tested compounds provide competition and accompanying cost reductions which are important for a sustainable health system to improve the care of as many Australians as possible," said Dr Moore.
Infliximab is dispensed predominantly via hospitals. Public hospital spending on infliximab for the 2015-16 financial year was $82.5 million3, making it the most costly therapy on the Highly Specialised Drug Program dispensed via public hospitals. Following the addition of the first biosimilar for infliximab on the PBS in December 20154, infliximab spending in Q1 of the 2016-2017 financial year saw a $4.1 million saving compared with spending in Q1 of the previous year3.
RENFLEXIS is the second biosimilar by MSD to be PBS listed, after BRENZYS® (etanercept) was listed on the PBS on 1st April 20175. MSD Managing Director Riad El-Dada said the company and its partner Samsung Bioepis were pleased to continue to seek approvals of and listings for its portfolio of high quality biosimilars in Australia.
The company noted, however, the challenges to date of successfully launching biosimilars in Australia, and the significant investment required. Adoption of biosimilars has been constrained by misalignment across key stakeholders and, as a result, the full potential of these medications has yet to be realised.
"We know that in order to be successful we need to support the scientific community and earn the confidence of prescribers. We also know that there are substantial savings that the Government can realise through a robust policy to promote biosimilars use, as outlined in the Strategic Agreement between the Commonwealth of Australia and Medicines Australia6. We will continue to try to work with all stakeholders to forge a path forward that serves the interests of patients, doctors, pharmacists and the Government," said Mr El-Dada.
RENFLEXIS is an anti-tumour necrosis factor-alpha (anti-TNF-α) biosimilar that reduces inflammation2. The approval of RENFLEXIS in Australia was supported by clinical studies where RENFLEXIS demonstrated biosimilarity to the originator medicine2,7.
In a Phase 3 randomised controlled study of 584 patients with moderate to severe rheumatoid arthritis, RENFLEXIS demonstrated comparable safety and equivalent efficacy (ACR20) to the originator infliximab at week 308.
All medicines have adverse effects and may impact different people in different ways. The following adverse effects are commonly seen (>1:100) in patients taking infliximab: viral infection, serum-sickness-like reactions, headache, vertigo/dizziness, flushing, upper respiratory tract infection, fever, lower respiratory tract infection, dyspnoea, sinusitis, nausea, diarrhoea, abdominal pain, dyspepsia, abnormal hepatic function, rash, pruritus urticaria, increased sweating, dry skin, fatigue, chest pain, and infusion related reactions2.
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