22.02

2018
Growth of Biosimilars in Australia
Written by Dr Niamh O’Reilly

 

In a previous blog, we predicted the controversy surrounding biosimilars would be a hot topic in 2018 and this certainly looks to be true.1 Uncertainty around issues such as naming, prescribing and dispensing has hampered uptake of biosimilars in Australia. So, what do the stakeholders involved need to ensure that uptake improves and the potential healthcare savings are realised?

Background on Biosimilars

Biosimilars are medicines produced using living cells that are similar but not identical to an approved reference biological. Although there may be slight variations between both products, biosimilars must be sufficiently comparable and provide the same health outcomes as the reference brand. Biosimilars have a shorter timeframe and are less expensive to develop than the reference brand (Figure 1). With biosimilars there is generally a shorter pre-clinical/clinical study process, particularly as the dosage, efficacy and side effects are the same as for the reference brand.2 This can result in a drug that offers the same health outcomes at a price 20-40% lower than the reference drug.2

Figure 1. Reduced cost for production of biosimilars.

Adapted from ‘Biosimilar Development: Incentives and Challenges’. 2

Australia’s Approach to Biosimilars

Governments and payers globally are feeling the pressure to fund spiralling healthcare costs and Australia is no exception. In 2017, six of the top ten most expensive drugs for the Pharmaceutical Benefits Scheme (PBS) were biological medicines costing government over $1.25 billion.3 The introduction of biosimilars is expected to deliver significant savings, improve competition and increase access for patients.

In line with realising these benefits, the Australian government has pledged to increase uptake of biosimilars with the introduction of two ‘uptake drivers’.4 The first driver encourages prescribing of biosimilars rather than the reference biologic for treatment naïve patients via several mechanisms. This means doctors are encouraged to prescribe the biosimilar to patients receiving treatment for the first time. The second provides a streamlined approval process for prescribing biosimilars when switching from the originator brand.4

Australia has taken a comparatively pro-substitution approach, for example allowing the “a-flagging” of anti-TNF biosimilars. A-flagged biosimilars can be substituted by pharmacists at the point of dispensing without permission from the prescribing clinician.5 No other regulator currently allows substitution of biosimilars at pharmacy level. The US has a law in place that may allow pharmacy substitution but only for products with ‘interchangeability designation’ which has yet to be granted to any product. To achieve this designation in the US, data must be provided to demonstrate no clinically meaningful differences in safety, purity and potency from the reference product.6

Safety Concerns

Substitution of biosimilars is a complex and developing area of clinical practice that requires cooperation and communication between the payer, doctors and pharmacists to ensure patient safety. Patients using biological therapies are potentially at risk of immune-based adverse reactions.7 The introduction of biosimilars has brought new concerns associated with switching from reference brand to biosimilar and the potential for multiple switches back and forth.7 However, there is some reassuring data from studies assessing the outcomes associated with switching between therapies, although this data is limited.7 A further concern associated with multiple switches is the difficulty in discovering which medication has caused the reaction. Immune reactions may take some time to become obvious at which point patients could be taking other medications.8

Some doctors have spoken out against a-flagging of biosimilars due to potential unknown risks associated with multiple switches.9 The practice has even been questioned given that decisions on a-flagging are made by the Pharmaceutical Benefits Advisory Committee and not the Therapeutic Goods Administration as the regulator.9 As more a-flagged biosimilars become available, the responsibility for pharmacists to provide upfront counselling to patients will increase. They will need to ensure patients understand the potential risks involved with switching to a new medication and how to accurately report any adverse reactions, otherwise there may be potential medico-legal implications. For their part, patient groups have urged patients to communicate with their healthcare professionals to ensure they receive the most suitable medication, understand any potential risks and know how to accurately report adverse reactions.9-11

CRC’s business model is designed to deliver Medical Affairs solutions that can address external healthcare policy changes and so continue to build value for our clients as regulatory and market access landscapes evolve.

 

References

    1. O’Reilly N. 2017. What lies ahead for medical affairs in 2018? https://crcaustralia.com/media-releases/what-lies-ahead-for-medical-affairs-in-2018/
    2. GBI Research. 2017. Biosimilar development the incentives and challenges. https://www.pharmaceutical-technology.com/comment/commentwhat-are-the-incentives-and-challenges-to-biosimilar-development-5751024/
    3. Haggan M. 2017. Expensive medicines used to treat hepatitis C have cost the government more than any other drugs over the past year. https://ajp.com.au/news/australias-10-expensive-drugs/
    4. PBS Website. 2017 Biosimilar Uptake Drivers. http://www.pbs.gov.au/info/general/biosimilars
    5. O’Connell K. & Madar S. 2017. Biosimilars balancing access to affordable medicines with safety. http://www.kwm.com/en/au/knowledge/insights/biosimilars-balancing-access-affordable-medicines-safety-20171101
    6. Welch A. R. 2017. What Systems Are Needed to Create a Viable Biosimilar Market? https://www.biosimilardevelopment.com/doc/what-systems-are-needed-to-create-a-viable-biosimilar-market-0001
    7. McKinnon R. & Ward M. 2016. Safety considerations of biosimilars. https://www.nps.org.au/australian-prescriber/articles/safety-considerations-of-biosimilars
    8. Arthritis Australia. 2015. Biosimilars and biologics: What you need to know. http://arthritisaustralia.com.au/indexphp/63-news/301-biosimilars-and-biologics-what-you-need-to-know.html
    9. Doctor Portal. 2017. Controversy over arthritis biosimilar listing. https://www.doctorportal.com.au/controversy-over-arthritis-biosimilar-listing/
    10. Crohn’s & Colitis Australia. Biosimilars and biologics: what it means for you. https://www.crohnsandcolitis.com.au/biosimilars-and-biologics-what-it-means-for-you/
    11. Creaky Joints Australia. 2017. Biosimilars in Australia – patient information. https://creakyjoints.org.au/biosimilars-australia-patient-information-2017/