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Community Pharmacists to Play Major Role in Biosimilars

Biosimilar BRENZYS® (etanercept) available on PBS from 1st April

Etanercept biosimilar part of MSD and Samsung Bioepis’ Combined Australian Biosimilar Strategy

SYDNEY, 3 April 2017 – MSD has today announced the availability of biosimilar BRENZYS (etanercept) on the Pharmaceutical Benefits Scheme (PBS) from 1st April.

BRENZYS is indicated in adults for the treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), plaque psoriasis, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis. BRENZYS is not indicated in children under 181.

BRENZYS will be the first PBS listed biosimilar of etanercept, providing an alternative to the originator etanercept. PBS expenditure on the originator etanercept was approximately $165 million in 2015-162, making it the seventh most costly treatment reimbursed on the PBS during 2015-162.

BRENZYS has been granted an ‘a’ flag status by the Pharmaceutical Benefits Advisory Committee (PBAC)3. The ‘a’ flag status means BRENZYS and the originator etanercept are marked as equivalent in the Schedule of Pharmaceutical Benefits, for the purposes of substitution by the pharmacist at the point of dispensing for all the circumstances (restrictions) that both brands are listed against3. The substitution process allows for prescriber and patient choice and is not automatic. For any individual prescription, a prescriber may choose not to permit brand substitution. If on the other hand, substitution has been permitted by the prescriber, the patient may choose which brand they wish to receive from the pharmacist.

Dr Mona Marabani, rheumatologist and chair of the biosimilars working group of the Australian Rheumatology Association said the PBS listing of BRENZYS introduces an alternative treatment option for rheumatologists and community pharmacists.

“It’s important that the Australian healthcare community works together to build understanding in these new products. Information and education will become increasingly important as more biosimilars become available alongside the originator biologics and careful long term monitoring will be vital,” said Dr Marabani.

MSD Medical Director Dr Gary Jankelowitz said MSD has worked closely with the Department of Health, the Generic and Biosimilar Medicines Association (GBMA) and other stakeholders ahead of this PBS listing.

“This is an important milestone given that it represents real progress in our efforts to offer Australian patients and healthcare professionals a pipeline of high-quality biosimilars in the future. We plan to bring more biosimilars to Australia in a range of disease areas that have potential to save PBS budget while providing access to a generally well tolerated and efficacious treatment1,” said Dr Jankelowitz.

MSD expects to launch a range of biosimilars in the coming years. The focus of these biosimilars will be in the areas of immunology and oncology of which the current value of the originator products is estimated at over $850 million per year5.

All medicines have adverse effects and may impact different people in different ways. The following adverse effects have been commonly reported patients taking BRENZYS: serious infections (including pneumonia, cellulitis, septic arthritis, sepsis, parasitic infection), infections (including upper respiratory tract infections, bronchitis, cystitis, skin infections), allergic reactions, autoantibody formation, injection site reactions, fever, pruritus, headache, rhinitis, dizziness, pharyngitis, cough, asthenia, abdominal pain, rash, respiratory disorder, dyspepsia and sinusitis. Other important adverse drug reactions include: malignancies (including melanoma, non-melanoma skin cancer, lymphoma, Markel cell carcinoma and leukaemia), psoriasis (new onset and exacerbation of pre-existing), tuberculosis, seizures, demyelinating events (CNS and peripheral) and worsening of congestive heart failure.

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

Healthcare Professionals interested in learning more about biosimilars should contact MSD on 1800 818 553.

Before prescribing, review the Approved Product Information. Product Information is available from www.MSDINFO.COM.AU/BRENZYSPI or is available on request from MSD.

Minimum PI for BRENZYS™
BRENZYS [etanercept (rch)]
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 non-melanoma 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.

BRENZYS is available on the PBS from 1st April 2017.

PBS Information: Authority required for the treatment of adults with severe active rheumatoid arthritis, severe chronic plaque psoriasis, active ankylosing spondylitis and severe active psoriatic arthritis. This product is not listed for the treatment of non-radiographic axial spondyloarthritis. Refer to PBS Schedule for full authority information.

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