Biosimilar Insulin FAQ

The EMA describes biological medicines as “a medicine whose active substance is made by a living organism”.

Examples of  biological medicines include insulin, vaccines, gene therapy, allergy extracts (i.e., allergy injections) and blood products. These medicines are especially important because they often provide treatment to people living with chronic conditions.
To read more on the definition of biologicals please see: FDA, What is a biological product?  And the EMA’s page on biosimilars.Insulin as a biological

Insulin is a biological medicine. In 1982, recombinant human insulin (or human insulin as it is commonly known) was actually the first biological medicine to be routinely used in clinical settings (Eli Lilly and Company’s Humulin®).

 

Because there are no longer any patents on human insulin, biosimilar human insulins have been developed by various manufacturers around the world since the 1990s. Biosimilar analogue insulins have only recently begun to come onto the market as the originator’s patents expire. For more about analogues and human insulin see FAQs about insulin.

While biosimilar analogue insulins are now appearing on the market, biosimilar human insulins have been used around the world for many years. If you see a biosimilar insulin on the market in your country, this means that it had to get approval from the same national regulatory agency as all of your other medicines do, and the approval is based on the standards that also apply to comparable medicines.
The regulatory approval process for biosimilar insulin can vary from country-to-country, as there are currently no global standards on the regulatory process. Some of strictest approval processes exist in the European Union (EMA) and the United States (FDA). The EMA has led the way on biosimilar medicines, creating the first guidelines on biosimilars in 2005 as well as insulin-specific guidelines. Our ACCISS report, released in 2017, found at least seven other countries to have insulin-specific guidelines within their biosimilar guidelines.

If you are a person who uses insulin and is curious about changing to biosimilar insulin, we recommend speaking to a health care professional about biosimilar insulins before making changes to your treatment plan.
If you are a health care professional and need more information about biosimilars, please see the guidelines prepared by the EMA and Australian Therapeutic Goods Administration (TGA) for health care professionals (see the links below) or find out more from your country’s regulatory authorities.

EMA  –  Biosimilars in the EU, Information guide for healthcare professionals
FDA   –  Biologics
Australian Department of Health – Biosimilar Awareness Initiative
Generics and Biosimilars Initiatives – List of biosimilar guidelines

The availability of biosimilar insulins opens up competition in the insulin market by allowing more companies to offer insulin to consumers. It appears that biosimilar medicines can lower prices of a medicine by 20–30 percent (Blackstone,et.al, 2013, Sarshad, 2017). While it is nowhere near the potential impact of generic medicines, which can lower prices up to 80 percent or more, it offers the opportunity to greatly impact consumer prices. A recent report estimated that health care systems in the US and EU could save up to US$120 billon using biosimilars (IMS Institute for Healthcare Informatics, 2016).  For example, in the US, a biosimilar of glargine was introduced in 2016 and has already lowered the price of the insulin by 15 percent.

The ACCISS Study has found that there are approximately 10 biosimilar insulin manufacturing companies in the world outside of the three largest insulin manufacturers (i.e., Eli Lilly and Company, Sanofi and Novo Nordisk). However, for biosimilar analogue insulin, only a few companies have been granted approval to market their medicines, particularly by the EMA and FDA.

Some examples of newly approved or to be approved biosimilar analogue insulins:

• Basalgar®/Abasalgar® (Eli Lilly and Co.) – a biosimilar version of glargine (Lantus®) insulin approved by both the EMA and FDA
• Lusduna® (Merck & Co.) – a biosimilar version of glargine, approved by the EMA
• Basalog® (Biocon) – a biosimilar version of glargine has been approved in Japan and there are plans for FDA approval
• Sanofi Lispro® has been recommended by the EMA for approval

A number of biosimilar insulins are now available in some markets, such as China, India, Mexico, the US and the EU, and other countries in the world. This means that in these countries, they have applied for, and received, marketing approval from the country’s medicine regulatory agency.

Substitution is where a pharmacist can exchange one brand of a biological medicine for its biosimilar in consultation with the person using the medicine, without having to refer back to the doctor. At the pharmacy, your pharmacist might ask if you are interested in changing to a biosimilar version of your insulin, which might cost less. You then can decide which brand you prefer, based on price or personal preference.
Sometimes, a doctor will override this action, by indicating on the prescription that brand substitution is not permitted (Llano et al, 2017).

Interchangeability refers to the possibility of one medicine being exchanged for another with the same effect. If a medicine is deemed to be interchangeable, a doctor can choose to recommend either brand of medicine based on a patient’s desires. Countries under the jurisdiction of the EMA make decisions about interchangeability per country ( Hakim, Ross, 2017). The FDA released draft regulatory guidance in 2017 that outlines a case-by-case approach on where a biosimilar such as insulin could be interchangeable (FDA).

The ACCISS Study supports any efforts to increase the availability and affordability of quality-assured insulin around the world. One way to do this is through increasing harmonisation and ensuring good standards for approving biosimilar insulins. Another way is to increase knowledge and understanding for people using insulin and their doctors about what biosimilar insulins are and how they are used.

Further reading

ACCISS Study Biosimilar Insulin Regulatory Profile and Factsheet
Christophe Perrin: What are Biosimilars? (Video)
EMA  –  Biosimilars in the EU, Information guide for healthcare professionals and Q&A for patients – Biosimilar medicines explained (available in 23 languages)
FDA   –  Biologics
Australian Department of Health – Biosimilar Awareness Initiative
Generics and Biosimilars Initiatives – List of biosimilar guidelines