Some drugs are similar and some are the same: The difference between Brand Name, Biosimilar and Generic There's an ongoing debate/discussion about if a generic drug is as good as a brand name drug, if a patient has a choice between brand and generic, and when a patient should be told which one to take. Now with advancements in science, there is another player in the game -- Biosimilars. Now there's another choice to consider when taking drugs. But how does this all fit together and what exactly are "biosimilars?"

Biosimilar does not mean generic.

Biosimilar is a term used when referencing biologic drugs. A biologic is a drug derived from living organisms, like humans, animals and microorganisms such as yeast and bacteria. You can’t combine ingredients to artificially create a biologic, it has to be grown. Current science does not allow us to make “identical” copies of a biologic yet. A “biosimilar” drug is exactly what the name implies -- it’s a biologic that is “similar” to another biologic drug already approved by the FDA. After rigorous testing the biosimilar is considered to be equivalent to a brand name biologic.

What makes a biosimilar different from a generic?

The term "generic drug" is applied to molecular drugs. Molecular drugs are all about chemistry and following a formula. An easy way to think of the difference between these drugs is a cookie recipe. Brand name patents use a very specific recipe with active and inactive ingredients to make cookies. When the patent runs out, other manufactures can come up with recipes of their own using inactive and active ingredients as long as the active ingredients stay the same. Generic drugs work like the cookies made after the patent runs out. They are required to have the same active ingredient, strength, dosage form, and route of administration as the brand name product. Generic drugs do not need to contain the same inactive ingredients as the brand name product. Generics are not organically grown drugs as compared to biologics, and they are based on the same "recipe" as a brand name drug. Generics are chemically derived products that are considered the same as the brand name product, where in the case of biologics the drug is “similar.” For both categories- biosimilar and generics, the FDA has an established, rigorous regulatory review process. Take a look at this infographic from the FDA explaining the process:  

What does the FDA say about biosimilars?

So - are biosimilars safe? Should patients consider them? Here's what the FDA has to say:

The Patient Protection and Affordable Care Act (Affordable Care Act), signed into law by President Obama on March 23, 2010, amends the Public Health Service Act (PHS Act) to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. This pathway is provided in the part of the law known as the Biologics Price Competition and Innovation Act (BPCI Act). Under the BPCI Act, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product. A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products. An interchangeable biological product is biosimilar to an FDA-approved reference product and meets additional standards for interchangeability. An interchangeable biological product may be substituted for the reference product by a pharmacist without the intervention of the health care provider who prescribed the reference product.

** Source:  Consumer report on Biosimilars from FDA. 

Why do we care about this issue?

The option for patients to receive a biosimilar drug as part of colorectal cancer treatment is on the horizon. Biosimilars and generics are different but they do have several things in common:

1. They have a shorter pathway through the FDA process (*that does not mean it is not rigorous)
2. They hope to increase patient access to therapies
3. They aim to reduce the costs of medicine and treatment

This is particularly timely for our community, as several drug patents for colorectal cancer treatment are coming to an end. As we get closer to the end of patents for colorectal cancer drugs, we will start seeing more generics for the drugs as well as “biosimilars.” For pharmaceutical companies, this is an emerging area of interest. As the market grows, the FDA will continue working to figure out the safest way to provide access to biosimilars to patients. To illustrate how new this market truly is, the first biosimilar was approved by the FDA for use on March 6, 2015!

Fight CRC's Role

Fight Colorectal Cancer will be monitoring the regulatory process for biosimilars to ensure the patient and advocate voice is infused in the discussion. We will notify patients when new treatment options are available so CRC patients can make informed decisions. View currently approved treatment options. Your role:  Join us in our Patient Resources Facebook group to ask us your questions and share your thoughts about biosimilars. Or, leave a comment below.