New Rheumatology Biosimilar BRENZYS™ (Etanercept) Secures TGA Approval
MSD has today announced that the Australian Therapeutics Goods Administration (TGA) has approved the biosimilar BRENZYS (etanercept) for the treatment of rheumatoid arthritis (RA), spondyloarthritis (AS), psoriatic arthritis (PsA) and psoriasis in adults over 18 years of age1.
BRENZYS is an etanercept biosimilar, which is a recombinant human tumour necrosis factor (TNF) receptor fusion protein that binds TNF and therefore reduces inflammation.
The approval of BRENZYS in Australia is supported by a Phase 3 clinical study in patients with rheumatoid arthritis that demonstrated efficacy in patients treated with once weekly subcutaneous 50 mg injections and compared BRENZYS to the originator medicine, etanercept2.
In this pivotal phase 3 clinical study, BRENZYS met the primary endpoints as well as all other efficacy and safety endpoints, demonstrating equivalence to the originator medicine in patients with moderate to severe rheumatoid arthritis (RA) taking concomitant methotrexate therapy. It also demonstrated a safety profile equivalent to the originator medicine etanercept2.
MSD Medical Director Dr Gary Jankelowitz said the company was excited at the opportunities presented by the registration of BRENZYS in Australia. “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.”
Dr Jankelowitz said the next focus is on a possible PBS listing given that BRENZYS was on the July PBAC agenda.
“Pending education of healthcare professionals and successful reimbursement, we would hope to make BRENZYS available in Australia in early 2017,” said Dr Jankelowitz.
If approved for reimbursement, BRENZYS will become the first immunology biosimilar in Australia to be predominantly dispensed via community pharmacy.
“We recognise that education will be pivotal to help raise awareness among community pharmacists on the role and benefits of biosimilars. These educational programs will take some time to implement,” said Dr Jankelowitz.
Dr Mona Marabani, rheumatologist and chair of the biosimilars working group of the Australian Rheumatology Association, said the emergence of new biosimilars in Australia could help contain costs and allow increased access to biologic/biosimilar treatments in rheumatology.
“These are significant changes and they bring new challenges and opportunities for both specialists and primary healthcare professionals in educating our patients about new options,” said Dr Marabani.
“Community pharmacies will play an important role as these drugs will be dispensed largely outside the hospital setting. We all need to be working together to maximise outcomes and value for our patients. Information and education for patients will become increasingly important as more biosimilars become available alongside the originator biologics and careful long term monitoring will be vital.”
MSD expects to launch a range of biosimilars in the coming years. The focus of these biosimilars will be in the areas of immunology, oncology and diabetes of which the current value of the originator products is estimated at around $1 Billion dollars per year3. The potential savings that biosimilars provide to the health budget will be substantial if healthcare professionals build confidence with biosimilars and come to see the public health benefits.
All medicines have adverse effects and may impact different people in different ways. The following adverse effects are commonly seen in patients taking etanercept: 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.
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.
About BRENZYS™
Indications: BRENZYS is indicated for the following: rheumatoid arthritis (RA); psoriatic arthritis (PsA); plaque psoriasis; ankylosing spondylitis (AS); non-radiographic axial spondyloarthritis in adults (≥ 18 years); It is not indicated for use in children under 18 years.
Adverse Events: The following adverse events are seen commonly or very commonly with BRENZYS: 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.
Contraindications: BRENZYS is contraindicated in the following: Hypersensitivity to any component of this product; patients with, or at risk of sepsis; patients with serious active infection including chronic or localized localised infections; concurrent treatment with Interleukin-1 antagonists.
Precautions: Infections: tuberculosis, hepatitis; hypoglycaemia in patients treated for diabetes; inflammatory bowel disease; concurrent administration of TNF inhibitors, anakinra or abatacept; haematological reactions; allergic reactions; congestive heart failure; neurological disorders; concurrent use in psoriasis; lymphomas, leukaemia, other malignancies, skin cancer; immunosuppression; vaccinations; autoantibody formation; fertility effects, use in pregnancy, lactation; use in elderly.
Administration: RA, PsA, AS and non-radiographic axial spondyloarthritis: 50mg per week SC. Plaque psoriasis: 50mg per week once weekly or initially 50mg twice weekly for 12 weeks then 50mg per week thereafter.
References
1. BRENZYS™ Product Information
2. Emery et al (2016) available here: http://ard.bmj.com/content/early/2016/05/04/annrheumdis-2016-209517
3. PBS Universe Data—accessed 26 July 2016