Page 32 - RP-MAY-2021

28 ETHICAL NEWS
PBS SLOT FOR ADALIMUMAB BIOSIMILAR ADDS CHOICE
MSD’s Hadlima has been listed on the PBS, creating for the first time an opportunity for doctors to prescribe and pharmacists to dispense a biosimilar of adalimumab.
Adalimumab is a biologic disease- modifying anti-rheumatic drug and was one of the highest cost medicines on the PBS last year, with $300 million
in sales in 2020, according to IQVIA [Midas MAT data through December 2020. Extracted March 2021].
“Hadlima plays an important role in providing patients with treatment choice and this listing furthers our commitment to creating a sustainable PBS by using biosimilars to help reduce the cost of medicines for Australian taxpayers,” MSD Biosimilar Business Unit Director Mick Van Lathum said.
“Prescribing and dispensing biosimilars allows doctors and pharmacists to play their part as responsible stewards of the PBS.”
According to MSD, a biosimilar medicine is highly similar to a ‘reference biological medicine’. Biosimilar medicines are tested in Australia for safety and to confirm they provide the same health outcomes as the reference biological medicine.
“Listing biosimilars is an important first step, but more must be done from policymakers to create a competitive environment for Australians to realise the full value of these medicines,”
Mr Van Lathum said.
Hadlima is a prescription only medicine that is PBS-listed for severe active rheumatoid arthritis, severe
Crohn’s disease (adult and paediatric), moderate to severe ulcerative colitis, severe chronic plaque psoriasis, severe psoriatic arthritis, complex refractory fistulising Crohn’s disease, severe active juvenile idiopathic arthritis (adult and paediatric), ankylosing spondylitis, and moderate to severe hidradenitis suppurativa.
Hadlima is available on the PBS as part of a development and commercial agreement with Samsung Bioepis. Under the terms of the agreement, MSD is responsible for all commercialisation activities for products approved in its partnered territories, while Samsung Bioepis is responsible for preclinical and clinical development, process development and manufacturing, clinical trials and regulatory registration.
UPDATE ALLOWS SALE OF BANNED SKIN LIGHTENING PRODUCTS
The TGA has clearly defined the parameters of use of arbutin, a naturally occurring derivative of hydroquinone, used in cosmetics products for skin lightening.
The organisation recently released an update in the latest edition of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), differentiating the different types of arbutin and their allowable concentration before mandatory SUSMP labelling must be used.
This action, which means a great deal to the cosmetic industry, be it manufacturers, importers or distributors, enables the sale of a significant number of products previously banned in Australia.
Arbutin works by slowly releasing hydroquinone through hydrolysis, which in turn blocks tyrosinase activity and reduces the skin’s melanin (pigmentation) production.
While the TGA’s rollback is good news for the cosmetic industry, it’s important to note that any supplier of the various types of arbutin used in cosmetics must be able to prove
that the hydroquinone levels present in the arbutin are less than 10mg/kg.
STUDIES SHOW REDUCED PAIN AS PBS LISTS CITRATE- FREE HUMIRA
Humira (adalimumab) citrate-free formulation will be available to eligible Australian patients via the PBS, according to AbbVie.
In two phase 2 studies, statistically significant reductions in
injection site pain were seen two minutes after injection with the new formulation compared with the previous one.
A survey of 76 inflammatory bowel disease patients also found that the new formulation of Humira was associated with a reduction in pre-administration anxiety and a reduction in injection site pain, which may impact on patient adherence
to treatment.
Humira is currently indicated in Australia for 10 autoimmune conditions across rheumatology, dermatology and gastroenterology.
AbbVie says it has consistently delivered innovation through Humira, ranging from improvements related to ease of dosing, accessibility with expanding indications and a comprehensive patient support program. The launch of the Humira citrate- free formulation represents the next phase in this ongoing innovation, the company said.
RETAIL PHARMACY • MAY 2021