Questions and Answers About Biologics and Biosimilars

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With biosimilars becoming less of an idea and more of a reality in the United States, patients with inflammatory bowel disease (IBD) will have many questions about these drugs. Biosimilars are biologic drugs, but they are not the same as the name-brand biologic drugs. This opens up many questions — for both physicians and patients — as to how a biosimilar can be used to treat IBD.

While biologic drugs are used to treat conditions other than IBD, interpreting the results from a study done on patients without IBD is problematic. This is because IBD patients have different levels of these drugs in their bodies than people who do not have IBD. Therefore, it may be some time before we have good data from well-designed clinical studies on biosimilar drugs in people with IBD.

We don't yet have the answers to many of the questions, but we can apply what we do know already and come up with some theories. Here's what we know now about what patients can expect from biosimilars. 

Biologic Drugs

Biologic drugs are medications that are used to treat diseases and conditions, and in IBD, are sometimes used to slow down or stop inflammation in the body. Biologic medications that are approved to treat IBD include Humira (adalimumab), Cimzia (certolizumab pegol), Remicade (infliximab), Tysabri (natalizumab), Simponi (golimumab), and Entyvio (vedolizumab).

If a Patient "Fails" a Biologic, Is the Biosimilar an Option?

As we know, everyone with IBD responds to medication differently. Some people with Crohn's disease or ulcerative colitis may not respond to a biologic drug or may become intolerant to it over time. Inflammation or symptoms are either not affected by the drug or they may start to come back despite the use of the drug. When this happens it's often referred to as "failing" the drug. This isn't a failing on the part of the patient or the doctor or the drug, but this is the term that's used. What it means is that the drug didn't work on the inflammation from IBD, and if it's not working, obviously you stop trying it. Physicians may also refer to the different scenarios as "primary" or "secondary" failure, depending on whether the drug never worked at all, or if it worked for a time and then stopped.

When a patient doesn't respond to the name-brand biologic, a choice needs to be made about what medication to try next. Trying the drug that is the biosimilar of the name-brand biologic, however, is thought not to be an option. If, for instance, a patient is allergic (or has an adverse reaction) to a particular biologic, the patient will probably also be allergic to the biosimilar. And, while a biosimilar is not going to be an exact duplicate of the name-brand biologic, it's currently thought that a patient who doesn't respond to one probably won't respond to the other. Therefore, it's thought that the biosimilar won't provide another treatment option for a patient that has already failed the biologic (and vice-versa). 

Switching Between Biologics and Biosimilars

There is a concern that patients could be switched between a biologic and a biosimilar without their knowledge or consent. This sometimes happens with generic drugs: a physician may prescribe the brand name, but the insurance company is looking for cost savings, so the drug gets switched to the generic.

In the case of a biologic, at this point, it is unknown what will happen if a patient that is doing well on a particular biologic drug is switched to the biosimilar drug. There isn't any evidence to make conclusions about this scenario yet. However, it's thought that because a biosimilar and a biologic are not exactly the same, they won't necessarily be interchangeable in this way. Experts suggest that if a patient is doing well, they should continue receiving the drug they've been on, whether that is the name-brand biologic or it is the biosimilar.

Some states have passed legislation in regards to biosimilars, and others have legislation pending, but not every state is considering it. In most cases, the legislation includes language that makes it clear that only the exact drug ordered by the physician (either the biologic or the biosimilar) is to be used, and substitutions are only permitted if both the physician and the patient agree. 

The concern for IBD patients is that insurance companies may pressure patients into changing medications if a biosimilar is less expensive, even if the biologic has so far been effective. In regards to switching between biologics and biosimilars, Dr. Scott Plevy, Disease Area Stronghold Leader, Inflammatory Bowel Disease at Janssen Research & Development said (oral communication, February 2016) "you don't mess with success with these diseases." 

Is There a Place for Biosimilars?

While switching between a biologic and a biosimilar isn't considered a viable way to treat IBD at this point, actually starting therapy with a biosimilar could be an option for some patients. This offers another treatment option, which is good news for patients. Making a change from the biosimilar to the biologic could still be a problem, so that isn't thought to be an option. If a patient is doing well on a biosimilar, it's thought that the same drug should be continued, same as the reverse situation. 

The Price of Biosimilars

At this point, how the costs will pan out in the marketplace is still an unknown. Many are predicting that biosimilars will cost less than biologics. However, this isn't a guarantee, and there's the potential for a company that makes a biosimilar to charge a price similar to that charged by the manufacturer of the biologic. Because insurance policies differ, the situation is going to be based on individual coverage and whether or not the pharmaceutical company holding the patent on the biologic drug is offering price-matching or another cost-cutting measure, such as a patient assistance program. There are so many variables involved in pricing, it's difficult to predict. It is thought that pricing might be more competitive overall, for both biosimilars and biologics, which will be a great benefit to patients.

The Bottom Line

The landscape of treatment options for IBD patients in the US is changing. The approval of biosimilar medications is bringing forth many questions regarding their use that can only be answered over time. There is little data to go on so far with biosimilar medications, yet healthcare experts have made educated guesses as for how they might best be used in patients with IBD and other conditions. There will be more studies and laws and guidelines put in place in the months to come, but, as always, your gastroenterologist will be the best source of information regarding your treatment options.

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