Biosimilars are a hot topic when it comes to medication these days. Biosimilars offer an alternative to very expensive and tough to produce biologic drugs. Since their approval and introduction to the United States market, the interest in biosimilars has continued to grow.
Biosimilars are not a simple concept. The molecules they are based on are large and complex, so why should biosimilars be any less so? Biosimilars do offer hope to people who find their insurance is unable to cover some important treatments. If you’re interested in this new and exciting field of medical treatment, keep reading. Many common questions are answered within and hopefully can provide you with a basis on this topic.
The 5 Important Questions
1: What is a Biologic?
A: Most drugs are created through chemical synthesis. These are small molecule drugs. Biologics are instead what’s known as large molecule drugs. They are grown in a living environment. This is usually cells from plants or animals. Sometimes it can be from a microorganism. As they are grown, they become far more complex. They become what’s known as a “large molecule drug”. These large molecule drugs are far more complex than basic chemically created drugs. These drugs are called biologics.
2: How is a Biosimilar Different From a Biologic?
A: If a biosimilar is done right, the answer to this question is “not very”. Ideally, they should be the same. The complex nature of a biologic drug means that they can’t be replicated fully. As a large molecule, there are numerous connections and configurations that go into them. Tiny variations in a cell that the biosimilar is grown in, can mean a chemical structure difference. However, that’s where the difference ends. The effect of a biosimilar is the same as a biologic. The risk factors of a biosimilar are the same as a biologic. This incredibly close similarity is where the name “biosimilar” came from afterall.
3: Isn’t a Biosimilar Just a Generic Drug?
A: There are differences between generic drugs and biosimilars, though they share a common concept. As generic drugs are small molecule drugs, they can be manufactured chemically identical to the original. This can also be tested. Biosimilars can’t reach this level of perfection because of the natural variations. The one thing to point out is that biosimilars can’t even be tested and verified to be exactly identical. However, since they are so close and their properties are so close, they are equivalent treatment options.
4: What Are the Treatments Currently Available?
A: Currently, biosimilars are being produced and approved by the FDA that can replicate the effects of many biologic treatment options. This means that whatever those biologics are designed to treat, the biosimilars can treat it as well. Some of the conditions which currently have a biosimilar treatment options include: Rheumatoid and psoriatic arthritis, ulcerative colitis, neutropenia, Crohn’s disease, several forms of cancer, chronic kidney disease, plaque psoriasis and ankylosing spondylitis.
5: Do Biosimilars Have Additional Side Effects?
A: In most cases, biosimilars have the same side effects or the same levels of risk that their biologic has. In some cases, they may be slightly different. The idea here is that they are of the same level of risk. A minor symptom may be replaced with another minor symptom. Biosimilars are intended to have exactly the same effect as their biologic counterpart, so typically, symptoms should be the same.
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