Page 34 - RP-MAY-2021

26 ETHICAL NEWS
ADRENALINE AUTOINJECTOR LISTINGS EASE SUPPLY ISSUES
Anapen 500, Anapen 300 and Anapen 150 Junior (Anapen Junior) adrenaline (epinephrine) autoinjectors are now included on the Australian Register of Therapeutic Goods (ARTG) for the emergency treatment of anaphylaxis (acute severe allergic reactions) due to insect stings, food or other allergens.
Wholesaler Allergy Concepts says that, significantly, for the first time, this TGA approval arms Australians weighing 60kg and over living with anaphylaxis with access to a 500mcg adrenaline autoinjector dose. Among the world’s first countries to have granted approval for use of the Anapen 500mcg dose, Australia is now positioned at the forefront of global innovation in allergy and anaphylaxis management, the company adds.
Allergy & Anaphylaxis Australia CEO Maria Said welcomed the TGA approval of the autoinjector, citing its ability to offer choice to prescribers and their patients alike.
“It’s important for an individual at risk of anaphylaxis, and their treating doctor, to discuss adrenaline injector device options, and to choose a device that best suits their needs,” she said.
“Having the Anapen 500mcg dose available to those weighing 60kg and over in Australia is an important step forward.
“The listing of Anapen also provides welcome relief to those at risk of anaphylaxis, who have long been reliant on one device, and severely impacted during manufacturing delays, product recalls or supply shortages.
“Previously, Australians needed to use expired devices for life-threatening emergencies if they occurred during stock shortages. Furthermore, those who were diagnosed with anaphylaxis during shortages were left with no life- saving medication.
“Having another supplier guarantees an alternative device
option, should we experience a shortage of one adrenaline injector or the other.”
According to Allergy Concepts co-founder and Managing Director Martin Naef, the inclusion of Anapen on the ARTG represents a major milestone in meeting a key finding of the parliamentary inquiry into allergies and anaphylaxis.
“One of the key committee findings from the parliamentary inquiry was the need for the introduction of alternative adrenaline autoinjectors to the Australian market, to prevent future stock shortages,” he said. “The introduction of Anapen represents the first significant step towards addressing this serious public health issue.
“We’re excited to be the only company in Australia offering a complete product line for all Australians – from children weighing 15kg right up to adults weighing 60kg or more.”
“This marks an important innovation milestone in the management of allergy and anaphylaxis in this country, and reinforces Allergy Concepts’ commitment to providing more treatment options and solutions to Australian healthcare professionals and their patients.”
IDACIO LISTING A BOOST FOR AUTOIMMUNE DISEASE PATIENTS
Adalimumab biosimilar Idacio, from Fresenius Kabi, a global healthcare company that specialises in lifesaving medicines and technologies, is now available through the PBS.
“It’s an exciting moment and an important milestone for us as a company to launch our first biosimilar product in Australia,” Fresenius Kabi Country Manager Australia and
New Zealand Martin Monaghan said.
“Biosimilars are an important contributing factor to the
sustainability of the PBS, and in line with our philosophy of ‘caring for life’, the launch of Idacio provides a
new adalimumab choice for patients suffering with autoimmune disease.”
The Australian approval of Idacio (adalimumab) was based on the totality of evidence detailed in the comprehensive data package submitted to the TGA, including analytical, preclinical and clinical data in healthy volunteers
and patients.
Idacio is the first approved molecule of the Fresenius
Kabi biosimilars portfolio with a focus on autoimmune and oncology medicines.
The TGA approval and subsequent reimbursement on the PBS of Idacio is a significant development for the company and for patients, who now have a new adalimumab choice in Australia.
Idacio is PBS listed with schedule equivalence (‘a’ flag) for the same indications as Humira (reference product), except for paediatric patients weighing less than 40kg.
RETAIL PHARMACY • MAY 2021