Biosimilar RENFLEXIS (infliximab) available on PBS from 1st August

MSD has today announced the availability of biosimilar RENFLEXIS^® (infliximab) on the Pharmaceutical Benefits Scheme (PBS) from 1^st 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 1^st 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 medicine^2,7.

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.

For a full list of precautions and adverse events please refer to the Product Information for RENFLEXIS.

Before prescribing, please review the Approved Product Information.

RENFLEXIS^® (infliximab) Minimum Product Information:

Indications: Rheumatoid Arthritis (RA) in adults in combination with methotrexate; Ankylosing Spondylitis (AS); Psoriatic arthritis (PsA); moderate to severe Psoriasis; moderate to severe Crohn's Disease (CD) in adults, children and adolescents (6 to 17 years); Refractory Fistulising Crohn's Disease; moderate to severe Ulcerative Colitis (UC) in adults, children and adolescents (6 to 17 years). Contraindications: severe infections; history of hypersensitivity to infliximab, other murine proteins, any excipient; concurrent anakinra; congestive heart failure. Precautions: acute infusion reactions; delayed hypersensitivity reactions; past or current malignancies and lymphoproliferative disorders ; current moderate to severe COPD; UC with history or risk of dysplasia or colon carcinoma; skin cancers; cervical cancer; suspected drug-induced lupus; measure antibodies regularly; increased risk of infections: TB, invasive fungal infections (IFIs), sepsis, pneumonia; monitor for opportunistic infections; HIV, Hepatitis B or C; psoriasis: not to be used with other immunosuppressive agents, monitor when switching between biologics; significant haematological abnormalities; hepatobiliary events; not recommended in pregnancy (Category C) or lactation; avoid use in children and adolescents ≤ 17 years with AS, PA or PP, children under 6 years with UC or CD; caution in elderly due to risk of serious infections. Interactions: anakinra, abatacept, other biological therapeutics to treat indicated conditions; live vaccines/therapeutic infectious agents. Adverse Effects: Common: viral infection (flu, herpes infections), fever; serum-sickness-like reactions; headache, vertigo/dizziness; flushing; upper respiratory tract infection, lower respiratory tract infection (eg bronchitis, pneumonia), dyspnoea, sinusitis; nausea, diarrhoea, abdominal pain, dyspepsia; abnormal hepatic function; rash, pruritus urticaria, increased sweating, dry skin; fatigue, chest pain, infusion-related reactions. See full PI for full list of uncommon and rare AEs. Non-lymphoma and lymphoma malignancies, worsening and new onset psoriasis, and antibody development have been observed. The safety profile of RENFLEXIS was consistent with what has been previously reported for infliximab. Presentation: Powder for infusion, 100mg. Dosage: For adults and paediatric patients, administer infusion solution over a period of not less than 2 hours. Shortened infusion, of not less than 1 hour, may be considered in adult patients who have tolerated 3 initial 2-hour infusions. Induction Doses: Given as a single IV infusion at weeks 0, 2 and 6 in RA (3mg/kg) and in PsA, Psoriasis, moderate to severe CD, refractory fistulising CD and UC (5mg/kg). Maintenance Doses: Given after inductions doses every 6 weeks in AS (5mg/kg); and every 8 weeks in RA (3mg/kg; consideration may be given to adjusting the dose in increments of 1.5mg/kg up to a maximum of 7.5mg/kg with MTX); PsA (5mg/kg; alone on with MTX); Psoriasis (5mg/kg); Moderate to severe CD (5mg/kg; consideration may be given to adjusting the dose up to 10mg/kg for patients with incomplete response); Refractory fistulising CD (5mg/kg; for patients who does not respond to the initial three doses, no additional treatment with RENFLEXIS should be given; for patients who respond and then lose response, consider treatment with 10mg/kg); UC (5mg/kg; for patients who have not responded to the initial three doses, careful consideration should be given before persisting with further treatment).

Based on PI approved 28 November 2016.

PBS information for RENFLEXIS^®:

For a full list of precautions and adverse events please refer to the Product Information for BRENZYS.

Before prescribing, please review the Approved Product Information.

BRENZYS [etanercept (rch)] Minimum Product Information:

Indications: rheumatoid arthritis; psoriatic arthritis; plaque psoriasis; ankylosing spondylitis; non-radiographic axial spondyloarthritis in adults (≥ 18 years); not indicated for use in children under 18 years. Contraindications: Hypersensitivity to any component of this product; patients with, or at risk of sepsis; patients with serious active infection including chronic or localised infections; concurrent treatment with Interleukin-1 antagonists. Precautions: Infections: tuberculosis, reactivation of hepatitis B, worsening of hepatitis C; alcoholic hepatitis; hypoglycaemia in patients treated for diabetes; concurrent administration of TNF inhibitors and anakinra; concurrent administration with abatacept; haematological reactions; allergic reactions; congestive heart failure; neurological disorders; concurrent use in psoriasis; lymphomas, leukaemia, other malignancies, melanoma and nonmelanoma skin cancer; immunosuppression; vaccinations; autoantibody formation; fertility effects, use in pregnancy, lactation; not indicated in children under 18 years; use in elderly. Pregnancy Category: D. Interactions: methotrexate; abatacept; anakinra; cyclophosphamide; live vaccines; sulfasalazine; digoxin; warfarin. Adverse Effects: injection site reactions; infections; malignancies and lymphoproliferative disorders; autoantibody formation; psoriasis; headache; rhinitis; dizziness; pharyngitis; cough; asthenia; abdominal pain; rash, respiratory disorder; sinusitis; allergic reactions; fever see full PI. Dosage: rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis and ankylosing spondylitis: 50mg per week SC. Plaque psoriasis: 50mg per week once weekly or initially 50mg twice weekly for 12 weeks then 50mg per week thereafter. See full PI.

Based on PI approved 19 January 2017.

PBS Information for BRENZYS:

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