You’ve heard of generic medication, but have you ever heard of a biosimilar?

This term has recently become more popular outside the pharmaceutical world thanks to a congressional ruling meant to increase competition in the biologics market.

If you’re confused about what this word means and the pros and cons of biosimilars, you're not alone. In this article, we’ll walk you through everything you need to know about biologics, biosimilars, and how the two interact to make prescriptions more affordable for all.

What Is a Biosimilar?

A biosimilar is a biological product with a very similar structure and function to a previously FDA-approved biologic drug.

Unlike traditional medications, biologics are made from living organisms or parts of living organisms. The molecules that make them up are much larger and more complex than non-biologic synthetic medications.

One of the most well-known biologics is insulin, which is made of highly complex peptides. Some other well-known examples include vaccines, botox, and growth factor products.

Novel biological medications are called biologics. Any reproduced versions created to be highly similar to these originals are called biosimilars.

Is a Biosimilar the Same as a Generic?

Because traditional medications are made synthetically, it is very easy to reproduce the formula to make an identical product. When this occurs, the subsequent formulations are known as generics.

But the process of reproducing biologics is far more complicated. Without access to the patented method of production, recreations of these types of drugs can be very similar to the original but never exactly the same.

When a recreation has a highly similar structure and function as the reference product, it is eligible to be named a biosimilar. The FDA tests these products to assure they have no clinically meaningful differences in safety, purity, or potency compared to the reference drug.

In terms of the market, biosimilars and generics play a very similar role. This is something we will touch on further down the page.

Why Are Biosimilars Just Now Becoming Available?

The first biosimilar was approved by the FDA in 2015, five full years after the Biologics Price Competition and Innovation Act was passed.

The lack of biosimilars hitting the market had a lot to do with legal injunctions being filed by companies who owned the patents to the biologics being reproduced. 

More recently, congressional rulings and changes put in place by the FDA have made it easier for companies to create and launch biosimilars.

In the last few years, we have seen many new biosimilars hit the market. The number of biosimilar insulins, however, remains very small. Those that are currently available are made by the same three companies that produce all of America’s name-brand insulins.

Are Biosimilars as Good as Name-Brand?

One requirement for biosimilars to obtain FDA approval is they must produce the same results as the reference product. They must be just as effective, just as potent, and just as safe.

There can be no clinically meaningful differences in how the biosimilar performs or in the side effects it has.

You can feel confident that any biosimilar on the market will work as well as the reference product it was made to emulate.

How Can Biosimilars Reduce Insulin Prices?

Like generic drugs, biosimilars are marketed at a much lower price than name-brand options. Not only does this give the customer a more affordable option for their treatment, but, over time, biosimilars help drive down the cost of the original reference drug as well.

If a drug is available that produces the same results as the original but costs less, the only choice the name-brand company has in order to compete is to lower the price of their product.

In the insulin market, this kind of competition is something that has long been lacking.

Currently, only three companies produce insulins that are approved for use in the United States. The market price of these name-brand insulins far exceeds the production costs of each drug. But, without more affordable options, the companies have no reason to lower their prices (or their profit margins).

Some of these companies have produced their own biosimilars in the hopes of appeasing congress’ appeal for lower insulin prices. Unfortunately, these big-name companies control where their cheaper drugs are distributed and can easily manipulate the market so their high-priced, name-brand products remain the most accessible option.

The key to truly lowering insulin prices is to foster real competition by introducing effective and affordable biosimilars created by new companies dedicated to seeing their products become a success.

What is Insulin?

Insulin is a hormone made by the pancreas. It allows your body to use glucose, a type of sugar found in many carbohydrates, for energy. After eating, the digestive tract breaks down carbohydrates and changes them into glucose that is then absorbed into your bloodstream through the lining in your small intestine. Once glucose is in your bloodstream, insulin causes cells throughout your body to absorb the sugar and use it for energy. 

Insulin also helps balance your blood glucose levels. When there’s an excess of glucose in your bloodstream, insulin signals your body to store that in your liver. The stored glucose isn’t released until your blood glucose levels decrease e.g., between meals or when your body is stressed or needs an extra boost of energy

Diabetes occurs when your body either does not produce insulin (Type 1) or it does not produce enough insulin (Type 2). Injections of insulin can help treat both types of diabetes, replacing or supplementing the body’s insulin.  People with type 1 diabetes can’t make insulin, so they must inject insulin to control their blood glucose levels. Those with type 2 diabetes potentially can manage their glucose levels by lifestyle changes or oral medication. But eventually, even type 2 diabetics may simply not be making enough insulin, and also need insulin to control their blood glucose levels.

What are the Different Types of Insulin Available?

There are multiple types insulin available to treat diabetes and all insulins produce the same effect: they mimic the natural ebbs and flows of insulin levels in the body during the day. The different types vary in how quickly they work, their peak and how long they last. Some work quickly while others work a little slower. Some last for a longer time in your body, while some have a short life.

Here’s a quick glance at commonly used insulin and how they work:

Rapid-acting insulin

Rapid-acting insulin (bolus insulin) is typically used to provide a surge of insulin at mealtime to lower glucose levels after eating. It acts very fast beginning to work approximately 15 minutes after injection, and lasts between 3 - 4hours. It can either be injected or used in an insulin pump.

Short-acting insulin

Short-acting insulins (regular insulin) are not as quick to act as rapid acting insulins it usually takes effect between 30 and 60 minutes. It’s usually taken before a meal to control postprandial blood glucose levels and is longer-lasting than rapid-acting insulin, being effective between 5 – 8 hours.

Intermediate-acting

Intermediate-acting insulin starts working in one to two hours and lasts about 10 to 16 hours. It is typically used to maintain a low and steady level of insulin in the body throughout the day. It is known as basal or background insulin replacement  and is intended to be administered twice per day.

Long-acting insulin

Long-lasting insulin is similar to immediate-acting insulin in that it offers a steady level of insulin. But it’s meant to last 20 to 24 hours so that you only have to take it once per day.

Pre-mixed insulin

In premixed insulin, shorter or rapid acting insulin is combined with longer acting insulin.