What might happen next year when up to four biosimilars hit the market in Australia to compete with the biggest selling drug of the last two decades, Humira?
Join tonight’s webinar audience to discuss what might happen next year when up to four biosimilars hit the market in Australia to compete with the biggest selling drug of the last two decades: Humira.
In 1984 in the US, generics accounted for 19% of retail prescriptions of synthetic drugs. In 2016 they accounted for nearly 90%. The shift has turned the economics and delivery of synthetic drugs in most major western countries upside down.
Biosimilars are a version of generics but for the far more complex and expensive drug class of biologics. One of the first and most well known biologics is Humira (adalimumab). When it was launched nearly two decades ago it introduced an era of increasingly effective targeted therapies in chronic conditions like arthritis, Crohn’s disease and severe asthma. Biologics are also making a major contribution in oncology.
But because of the complexity of the development and production process, biologics are significantly more expensive than synthetics both to develop and manufacture.
In Australia, without a PBS listing, a typical course of 6 Humira 40mg/0.8mL injections would set a patient back over $5500. With PBS that cost is reduced to only $41.
Such a price differential isn’t an immediate concern to patients as they only see what they pay at the pharmacist. But it probably should be, because funding biologics is an expensive game for the government and the PBS. Biologics are life changing drugs for many conditions, and we are getting more and more of them. But the more that are funded, the more the PBS is put in a position of having to decide between drugs to fund.
That’s why biosimilars are of such interest at the policy and government level in most western economies.
Biosimilars and generics are different because while generic drugs are identical to the original in chemical make up, biosimilars are not because the production process is biological. For the purposes of patient safety and approval, they are deemed “close enough” by drug regulatory bodies to accomplish the same therapeutic and clinical result within acceptable safety limits.
Biosimilars also vary considerably from generics in the economics of development.
Biosimilar development can take five to nine years and cost more than $130 million. And that is before you get to your regulatory application. A generic can cost as little as $1-2 million and take only two years to develop.
So far in Australia 26 biosimilars have TGA approval and of them 17 have a PBS listing. Most of the PBS-listed entities aren’t being marketed. Only one in rheumatology has really established itself in the market.
But next year there are four TGA approved Humira biosimilars planning to launch, which should for the first time start to stress test whether biosimilars might ever find a place in Australia anything like generics.
Tonight Rheumatology Republic, a sister publication of The Medical Republic, is holding a free webinar featuring three key industry panellists representing the patient, the doctor and the pharmacist. They are:
– Seth Ginsberg – founder of international online arthritis patient community, Creaky Joints, and chronic illness patient support initiative, The Healthy Living Foundation
– Dr Irwin Lim – Rheumatologist , Director of BJC Health and editor-in-chief of Rheumatology Republic, and
– Dr Greg Kossena – community pharmacist, managing partner Cowes Pharmacy, Victoria
As well as the broader topic of the economics and politics of biosimilars the panel will be discussing:
– whether active ingredient prescribing can be set up to avoid confusion and prescriber fatigue.
– how biosimilar prescribing will likely work with prescribing software and whether there will be any ways to optimise the process.
– what is likely to happen at the pharmacy level with patients after prescribing – will pharmacies actually stock four biosimilars?
– how “A” flagging will work with so many options.
Register HERE to watch the webinar live, or access a video of the session at any time after the event.
Sponsored by Sandoz.
Time : Dec 10, 2020 07:00 PM in Canberra, Melbourne, Sydney