Should You Be Concerned About Biosimilars?


Biosimilars are drugs that are almost identical to the original, which are made by a different company. And it is that “almost” that has many pharmacists and physicians concerned about the use of biosimilars.

The FDA says that biosimilars are highly similar to the originals, known as reference drugs, but they are not completely interchangeable. Biosimilars, however, have no “clinically meaningful differences” to the original in terms of safety, purity and potency, according to the FDA.

Because the biosimilar is not exactly the same as the original, all of the data gathered from the testing of the original drugs regarding their safety and effectiveness cannot be applied to the biosimilars, according to healthcare industry experts. The effectiveness and safety of the biosimilars could be different depending on the therapy and the patient populations.

Drugs that are interchangeable with the originals – such as generics – will produce the same result as the original drug no matter the patient, and the risk of using the substitute is no greater than the original. Some physicians want assurances from the FDA that a biosimilar is interchangeable with its original before they will prescribe the biosimilar.

To forestall any safety issues related to biosimilars, experts in the healthcare industry are recommending two solutions.

More data gathering on the effects of biosimilars.

In this scenario, healthcare researchers would continue to gather data on biosimilars that are now on the market. This data is necessary to determine more precisely the frequency and severity of side effects of biosimilars compared to the originals. Studies conducted before the biosimilars were put on the market are not comprehensive enough to offer conclusive evidence on the safety and efficacy of biosimilars, according to healthcare experts.

Physicians will have more confidence in the biosimilars as they begin to see more critical, peer-reviewed studies on their safety and effectiveness. Just how these studies would be carried out has not yet been determined, however.

Looking to Europe.

In Europe, some biosimilar drugs have been on the market for several years, and evidence shows the biosimilars used in Europe are as safe and effective as the originals.

Some healthcare officials are recommending healthcare organizations in the United States look at the safety and efficacy data collected on the drugs used in Europe to learn more about them. Data put together by European healthcare agencies will also be important in helping physicians and pharmacists in the United States gain confidence in the biosimilars.

Meticulous data collection on the biosimilars will be the keystone of any efforts to bring these drugs into the mainstream, according to some experts.

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