Facts about biosimilars

Biologic response modifiers have transformed the lives of patients with inflammatory arthritis who need them. Today, there are several biologic originators that have lost their patents, or will lose their patents, and biologic biosimilars are coming into the market place.

A biosimilar is a biologic that has similar effectiveness, safety, immunogenicity profile and quality, and delivers the same therapeutic benefits to patients as its biologic "originator". They are typically prescribed to patients by a rheumatologist or other specialist. For example, etanercept (Brenzys®) and etanercept (Erelzi®) are biologic biosimilar versions of the biologic originator etanercept (Enbrel®); infliximab (Inflectra®) and infliximab (Renflexis®) are biologic biosimilar versions of infliximab (Remicade®).


Biosimilars are not generics of their biologic originators
Biosimilars are similar, but not the same, as their biologic originators

Due to the size, complexity and natural variability of biologic medications, and because biologic medications are made in living cells rather than with chemicals, a biosimilar and its biologic originator can be shown to be similar, but not identical.

For example, the way that etanercept or infliximab is manufactured makes it impossible to produce an exact copy of the molecule. This differs from other pill-form medications you may have taken before. Medications like methotrexate and ibuprofen are made of small chemical molecules, not proteins. When patents expire on small molecule medications and generic versions are authorized for manufacture, exact copies can be made.

Biosimilars have been approved for use in Canada since 2009, and for use in inflammatory arthritis since 2014. Seven biosimilars are currently approved by Health Canada with another 15 biosimilars expected to be launched by 2020. Since the European Union approved the first biosimilar in 2006, and in inflammatory arthritis in 2013, the EU has approved 28 biosimilars.

Based on this scientific evidence and real world data, rheumatologists across Canada are now regularly prescribing biosimilars for inflammatory arthritis patients newly initiated on infliximab and etanercept, and in full consultation with their patients, beginning to transition them from their biologic originator to its biosimilar.


Biosimilar Naming
Patient and healthcare professional groups have called for uniquely different brand naming for all biosimilars entering the Canadian market place to minimize confusion about which medication was being prescribed and filled at the pharmacy counter or infusion clinic, or taken by the patient. Unique naming is also very important when tracking adverse events at the population level.
Health Canada and the Institute for Safe Medication Practices Canada (ISMP Canada) are seeking input from healthcare providers, consumers, and other interested and affected stakeholders on different approaches to the naming of biologic drugs, including biosimilars, in Canada.
The objective of the consultation, between January 18, 2018 and February 9, 2018, is to gain insight into stakeholder views on the practical impacts of different approaches to the naming of biologic drugs and biosimilars throughout the medication-use process, including prescribing, dispensing, and adverse drug reaction reporting.

http://www.who.int/medicines/services/inn/WHO_INN_BQ_proposal_2015.pdf

http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformati...

 

Biosimilars in Canada

Seven biologic biosimilars are currently approved by Health Canada: infliximab (Inflectra®), infliximab (Renflexis®), etanercept (Brenzys®), etanercept (Erelzi®); somatropin (Omnitrope®); insulin glargine (Basaglar®); and filgrastim (Grastofil®).

Numerous biosimilars are currently under development globally. Health Canada is seeing a significant increase in the number of pre-submission and pipeline meetings with biosimilar manufacturers. Health Canada expects a significant increase in submissions as patent/data protections expire in Canada.

Experts predict another 15 biosimilars are expected to be launched in Canada by 2020. 

Why have biosimilars been developed and approved?

Biologics are treatments that can help patients with serious diseases such as inflammatory arthritis. However, they are complex and can be very expensive and time consuming to develop. This can limit patients’ access to such medicines, and can make it difficult for the healthcare system to afford them.

A biologic “biosimilar” enters the market after a biologic “originator’s” patent expires, like a small molecule generic medication does when the brand name medication’s patent expires.

Like legislated generic drug savings in Canada, biosimilars have the potential to improve patient access to biologics and save public and private healthcare systems billions of dollars now and over the coming years.

A study commissioned by the Patented Medicine Prices Review Board (PMPRB) and conducted by the National Prescription Drug Utilization Information System (NPDUIS), “Potential Savings from Biosimilars in Canada”, estimated potential savings for infliximab alone in Canada could range between $91M and $514M in the third year following biosimilar entry.

As reported at a Health Canada Biosimilar Workshop on March 20, 2017: “A competitive and sustainable market for biosimilar and innovator drugs could offer many benefits to the healthcare system, including broadening access to effective biologic treatments, reducing the cost burden and enabling savings to be re-directed across all areas of healthcare including funding of new innovative therapies.”

What benefits do biosimilars provide patients and our healthcare system?

Specifically, biosimilars create three main benefits to patients, the healthcare system, and society:

  1. Savings from biosimilars use can modernize “special access criteria”. Currently, patients must try and fail treatment on older, less expensive medications. Because biosimilars are significantly less expensive, public and private drug formularies can remove the need for patients to fail on these older therapies before approving reimbursement for them;

  2. Savings from biosimilars use can be reinvested into public and private drug formulary budgets making it possible to add new innovative medications coming into the market place, and by doing so, expanding patient medication choice; and,

  3. Savings from biosimilars can be reinvested into non-medication elements of care that patients need, such as specialized nursing, counselling, physio- and occupational therapy, among other important elements of a holistic inflammatory arthritis treatment plan.