Over the past five years, a number of ‘big brand’ biologics have gone off patent and have been replaced with biosimilars. This remains a challenge for any biologic nearing the end of the lifecycle, no doubt pushing prices up to achieve maximum return on investment for the short time available on the market. At FingerPost, we have been involved with a number of research projects looking at the impact of biosimilars – both from the perspective of the biologics nearing the end of their patent, and from the perspective of new biosimilars preparing to launch. We thought it would be interesting to review the current biosimilar situation in Australia and Canada, particularly as trust in biosimilars has grown amongst payers and healthcare professionals with increasing experience over the past few years.

Australia

As of 1 July 2020, the Sanofi Lantus® brand of insulin glargine is no longer reimbursed to treat diabetes on the national Pharmaceutical Benefits Scheme (PBS). The first biosimilar brand of insulin glargine, Semglee® (Alphapharm) was PBS listed in October 2019. 

Commencing in 2015, the Australian Government has introduced successive initiatives to encourage prescribing and dispensing of biosimilar brands of biological medicines. The Semglee® brand of insulin glargine was assessed by the Therapeutic Goods Administration (TGA) to be highly similar, based on the FDA definition, to the reference brand Lantus®.  Such assessments are then translated into opportunities for substitution.

These are signalled on the PBS by the practice of flagging: 
 ‘a’ flagging denotes that: 

• Brand substitution may be undertaken by pharmacists at the point of dispensing without difference in clinical effect or health outcomes. 
• Brand substitution by pharmacists is permitted without reference to the prescriber when the following conditions apply: the patient agrees to the substitution; and the prescriber has not indicated on the prescription form that substitution should not occur by ticking the box labelled ‘brand substitution not permitted’. 

 While ‘b’ flagging denotes that:  

• the brand is equivalent to the reference brand but it is not known if there is equivalence to the ‘a’ flagged brand. 
• All medicines flagged ‘b’ are substitutable by the pharmacist when the patient agrees to substitution and the prescriber has not indicated on the prescription form that substitution should not occur. 

The Education arm of the Australian Generic and Biosimilar Medicines Association (GBMA) received a grant of AU 5 million dollars (US 3.5 million) from the Australian Government in April 2018 to increase confidence in the use of biosimilars via peer-to-peer health communication activities. A further driver is the October 2019 introduction of active ingredient prescribing regulations. These require prescribers to include the active ingredient on all PBS prescriptions. A brand name can be included after the active ingredient where doing otherwise may pose a patient safety risk. Prescribing software must be updated to reflect these requirements. There are concerns that prescribers will be unable to identify products by brand.   

Insulin glargine 100 units/mL listings on the PBS now include the following note:

Biosimilar prescribing policy 
Prescribing of the biosimilar brand, Semglee, is encouraged for treatment naive patients. Encouraging biosimilar prescribing for treatment naive patients is Government policy. A viable biosimilar market is expected to result in reduced costs for biological medicines, allowing the Government to reinvest in new treatments. Further information can be found on the Biosimilar Awareness Initiative webpage (www.health.gov.au/biosimilars). 

​So back to Lantus®, Sanofi introduced the Optsulin® brand (available overseas) in January 2020, under the same PBS code 9039R, as the formulation, excipients and manufacturing process are the same. It is ‘a’ flagged. Through a partnership with the Australian Diabetes Educators Association, Sanofi’s insulin patients were able to call toll-free and speak with a Credentialled Diabetes Educator (CDE) about the transition. The commercial reason behind the re-branding exercise is unclear as the effective price of 100 units/mL has not changed. Special pricing arrangements (meaning a difference between the published and effective price) continue to apply to the Sanofi Toujeo Solostar® brand of insulin glargine 300 units/mL.

Canada

British Columbia:
British Columbia was the first province to initiate biosimilar switching policies. On May 27, 2019, BC PharmaCare launched the Biosimilars Initiative with the objective of switching patients using Enbrel®, Remicade®, and Lantus® for certain indications to their biosimilar versions by November 25, 2019. The second phase (September 5, 2019 – March 5, 2020) consisted of patients being switched from Remicade® for gastrointestinal (Crohn’s disease or ulcerative colitis) to a biosimilar version. The three biologic drugs selected for biosimilar switching were among the highest drug expenditures in BC, totalling $125 million in 2018. During the first phase of the initiative, 73% of 20,780 patients using the reference biologics were switched to biosimilars. During the second phase, based on initial partial numbers, 78% of patients on infliximab reference product were switched to biosimilars.

Alberta:
In Alberta, the government introduced the Alberta Biosimilar Initiative on December 12, 2019. This initiative requires adult patients currently on an originator biologic drug to switch to a biosimilar version, if available for their medical condition, in order to maintain drug coverage through the government sponsored drug plan. The products included in the Biosimilar Initiative are:

• Remicade® (all indications)
• Enbrel® (all indications except plaque psoriasis and pediatric juvenile idiopathic arthritis)
• Lantus® (all indications)
• Neupogen® (all indications)
• Neulasta® (all indications)
• Copaxone® (all indications)

Alberta spent over $238 million in the 2018 to 2019 fiscal year on biologics and with this initiative, the government anticipates saving approximately $30 million annually. The switching requirement was initially scheduled for July 1, 2020 but due to the COVID-19 pandemic, it was postponed to January 15, 2021.

Ontario:
On January 1, 2020, the Ontario Ministry of Health published a policy directive addendum to the Ontario Guidelines for Drug Submission and Evaluation which simplified requirements for biosimilar drug product submissions. The simplified submission no longer requires the biosimilar manufacturers to provide scientific evidence of clinical similarity between the biosimilar and its originator product – the rationale being that Health Canada does this assessment before approving the biosimilar. As a result, the biosimilar listing process on the public drug plan would be considerably quicker. In a report published by the Ontario Drug Policy Research Network (ODPRN) titled “Current and Prospective Utilization of Innovator Biologics and Biosimilars in Ontario,” a total of $1.1 billion was spent on biologic medications through the Ontario public drug program in 2018. The report found that biosimilar uptake in Ontario was low, with less than 1 in 5 biologic users accessing the available biosimilars.

Canadian Agency for Drugs and Technologies in Health (CADTH):
The Canadian Agency for Drugs and Technologies in Health published a report in January 2020 titled “Utilisation of Innovator Biologics and Biosimilars for Chronic Inflammatory Diseases in Canada: A Provincial Perspective.” The report addressed the findings of the ODPRN report and provided possible cost-containment mechanisms or strategies to optimize the benefits associated with biosimilar drugs alongside innovator biologics. The proposed possible approaches provided include:

• Controlled substitution of innovator biologics for biosimilars
• Reimburse biosimilars for newly diagnosed persons only – persons already being treated with an innovator biologic drug may remain on that treatment if their disease is stable
• Tiered reimbursement for innovator or biosimilar biologics – “tiers” would be based on the medicines’ relative value for money, with the most cost-effective options classified in the first reimbursement tier
• Prescribing quotas to incentivize use of biosimilars
• Provide access to biosimilars using tendering procedures

 
Physicians and Patients:
Lastly, what is the perspective of physicians and patients with regard to the biosimilar initiatives? The Canadian Association of Gastroenterology and Crohn’s Colitis Canada published the “Joint Canadian Association of Gastroenterology and Crohn’s Colitis Canada Position Statement on Biosimilars for the Treatment of Inflammatory Bowel Disease“

Included in their recommendations:

• A biosimilar may be started in patients who are naive to anti-TNF therapy rather than starting with the biologic originator but this is contingent on the price differential of the two drugs. If the price differential is modest, then the biologic originator should be used.
• Nonmedical switching from the originator biologic to biosimilar in patients whose disease is stable with treatment is not recommended.

Biosimilar policies will continue to evolve across Canada as public payers must balance managing their drug plan budgets while meeting  patient needs. Adding further complexity to this issue is the COVID-19 pandemic, the long-lasting impact of which remains unknown.