Biosimilar drugs are an advancement in pharmaceutical technology that improve the accessibility of many drugs Canadians need. If you own a Canadian business or you live and work in Canada, the availability of biosimilar drugs likely impacts your lifestyle and finances.
If you are not well-versed with health insurance terminology, you might have a few questions, like:
- What are biosimilar drugs?
- Do biosimilar drugs work as well as other drugs?
- Will biosimilar drugs save me money?
- Can biosimilar drugs affect the quality of my health care?
Even if the general health of you and your employees is good right now, things can develop over time as we age and worsen your health. Conditions like cancer, diabetes, and arthritis can be life-threatening and strike without warning.
It’s best to be prepared and proactive about your health in the future and aware of the pharmaceutical treatment options that are available. Health and dental group employee plans tend to cover prescription drugs for employees.
What Is a "Biosimilar Drug"?
Health Canada states that a biosimilar drug is a biological product that is extremely similar to an existing drug that is already on the market.
For agencies that regulate the quality and safety of drugs and food, such as the Canadian Food Inspection Agency or the United States Food and Drug Administration, a drug's specific status as a biosimilar pharmaceutical is imperative. If the synthetic version of a drug is already approved, the biosimilar drug could skip some of the regulatory hurdles that a new drug would be faced with.
Knowing "what a biosimilar drug is" requires clarifying what "similar" means.
Biosimilar does not mean identical. Drugs are often complex molecules with many moving parts. Some of them are binding sites that must exist for the drug to work effectively. Other parts of the drug are not so crucial to the drug's effectiveness, so minor changes do not affect the drug's efficacy.
How Are Biologic Drugs Manufactured?
Let’s answer the question, “what is a biosimilar drug?” While most of the specific details of biosimilar drug manufacture are proprietary, the general process involves using living cells to manufacture the drug.
Many drugs, like insulin, are already biological products. This means that a gene for the production of insulin already exists. For other drugs, manufacturers have to formulate the genes.
In order to create a biologic or biosimilar insulin, manufacturers would need to introduce a gene for insulin production into a cell. Researchers would take a bacterium, such as E. coli, a bacterium you might have heard of regarding food poisoning outbreaks, and inject it with the DNA for insulin.
By incorporating DNA into the bacterial genome, the researchers can then turn the cell's machinery into a sort of insulin factory. They harvest the insulin, remove any impurities, and package it for distribution.
Biosimilar Drugs vs Reference Drugs
A part of the question "what is a biosimilar drug" relates to the drug's legal status as intellectual property as much as it does to the science behind the drug's manufacture. Regulators measure a biosimilar drug's effectiveness in opposition to the original drug (also known as a reference drug).
The main distinguishing factor of the original (or originator) biologic is that someone else created it first. The originator is the reference standard because it has already been through the necessary clinical trials and steps in the approval process. The biosimilar drug can get through the approval process faster than the originator drug, but it still must pass through regulatory steps before doctors can prescribe it.
One of the differences between the biosimilar drug and the biologic drug is that the procedure for creating the drug and the product might differ from the patent for the originator biologic. This allows manufacturers to market the drug, which they would not be able to do if they create an identical copy of the originator drug.
Benefits of Biosimilar Drugs
Developing a biosimilar drug instead of a biologically identical drug allows for fewer intellectual property issues because patent protection might not cover the biosimilar drug.
Biosimilar drugs give patients and doctors more choices. Since biosimilar drugs can have slightly different effects, patients might respond better to one drug than another, experiencing better outcomes or even fewer side effects. If a biologic or a generic synthetic drug isn’t available, biosimilar drugs are a lifesaving alternative.
Disadvantages of Biosimilar Drugs
Biosimilar drugs require a longer development process than generic drugs. The manufacturer needs to convince regulatory agencies that the drug functions like the original drug. The clinical trial process might not take as long, but it still presents a considerable expense that will contribute to the final cost of the drug. Health Canada keeps watch on the effects of drugs after companies release them and can order updates to fix any safety issues.
Comparability and Interchangeability
Interchangeability is a concept that relates to the approved use of biosimilar drugs. If regulatory authorities decide that a biosimilar drug is interchangeable with its biologic originator, pharmacists can prescribe the biosimilar drug in its place.
If the drugs are not deemed interchangeable, a doctor has to write a separate prescription for the patient to receive the biosimilar drug. Doctors may switch from a biologic drug to a biosimilar drug if there are problems with the biologic drug. In these cases, the doctor would speak with the patient and tell them of any difference between the two drugs.
Regulators also evaluate the comparability of biosimilar drugs and reference drugs. Comparability means that the essential molecular components of the drugs are the exact same and that the differences do not minimize the efficacy of the biosimilar drug. The evaluation process includes analytical studies of the drug's structure as well as clinical trials.
How Available Are Biosimilar Drugs?
A recent paper in the Canadian Medical Association Journal says that only 31 biosimilar drugs are available in Canada as of 2022. Regulatory practices and intellectual property rules differ in other jurisdictions, such as the United States and the European Union, which have greater access to biosimilar drugs.
Manufacturers and regulators are working to streamline the testing and analysis of new biosimilar drugs so that vital drugs can efficiently enter the market without compromising the safety of the new drugs or the integrity of the regulatory process.
Biosimilar Drugs on the Market
To get a clearer real world picture, look at these examples.
Amgetiva
Amgetiva is a biosimilar drug that has basically the same effects as adalimumab (brand name Humira). The original drug and the biosimilar drug both treat arthritis, psoriasis, and other similar conditions. Humira and Amgetiva are monoclonal antibodies that work to interfere with the body's inflammatory response.
Semglee
Semglee is a biosimilar insulin that has gotten FDA approval for interchangeable use with insulin glargine which treats diabetes. The rising price of insulin in many countries and the high numbers of diabetes cases mean that any change in the marketplace that brings down insulin prices is likely to lower overall health costs and increase the affordability of insulin to millions of people in need.
Cancer Drugs
Cancer treatment is incredibly expensive, and many of the most promising cancer drugs are still new and covered by patent protections. The cost savings of introducing new cancer drugs into the marketplace has led to the development of biosimilar alternatives to many brand-name cancer drugs.
The following cancer drugs have multiple biosimilar relatives on the marketplace right now:
- Herceptin
- Filgrastin
- Rituxan
Many modern cancer drugs are great candidates for biological synthesis because they interact with the natural body processes that either enable or fight cancer. For example, immunotherapy cancer drugs use antibodies and other naturally produced chemicals to strengthen the immune system and trigger the demolition of cancer cells.
Where Are Biosimilar Drugs Being Researched?
Biosimilar drugs are an up and coming technology, so the number of biosimilar drugs on the market will inevitably rise in the coming years. Rising healthcare costs are a constant and worrisome problem in today’s society. Many technologies, including automation, telehealth, and advances in logistics, reduce the impact of increasing healthcare costs and allow more patients in Canada and globally.
Biosimilar drugs increase competition in the marketplace and can even reduce the amount of time that the manufacturer of an originator biologic can have exclusivity on the market.
As the technology behind the manufacturing and testing of biosimilar drugs becomes more advanced, the speed of drug development might increase drastically. Greater support for biopharmaceutical research creates a positive feedback cycle that could revolutionize healthcare and benefit patients, physicians, insurers, and investors.
Insurance Coverage and Biosimilar Drugs
Canadian healthcare provides good coverage to Canadian residents. But provincial healthcare does not cover everything. Prescription drug costs are expenses that Canadians need to pay for or they are covered through supplemental private health insurance.
Canadians and employers that offer private health insurance to employees need to understand the pharmaceutical marketplace, including biosimilar drugs, well enough to assess their needs and evaluate different plans.
Even if you can now answer the question, "what is a biosimilar drug," the host of options can be stressful to sift through. Seeking help from a company that specializes in setting up group plans can make the process easier and improve the options available to employees.
Have More Questions About Biosimilar Drugs and Private Health Care Plans?
Insurdinary partners with all of the major Canadian health insurance providers to provide competitive rates to individuals that use our services.
If you want to know more about biosimilar drugs or inquire about your health insurance coverage, contact us. One of our experienced agents would be happy to assist you. We look forward to working with you.
