Humira biosimilar may work as well as the original

| Melissa Leavitt

You—and your pocketbook—are probably familiar with generic drugs. When your pharmacist gives you a generic medication instead of a brand-name, you often get the same treatment results for less money. The only place you’re likely to feel the difference is your wallet.

With biologics, it’s a little bit trickier. Because of the way biologics are made, there are no generic versions identical to the original.

Biosimilars are drugs that are similar to a biologic but not an exact copy. Because they are not replicas, many doctors and patients are asking if they will be as effective as biologic drugs and whether they’ll really be easier on your wallet.

Read about the NPF’s position on biosimilars here.

A biosimilar for Remicade (infliximab), called Inflectra (Infliximab-dyyb), received U.S. Food and Drug Administration (FDA) approval on April 5.

Many other biosimilars for common psoriatic disease drugs Humira (adalimumab) and Enbrel (etanercept), as well as Remicade, are being developed and tested. As part of these tests, they are compared to the original.

Research presented at the 2016 American Academy of Dermatology meeting in Washington, D.C., provided data from a Phase III trial comparing the biologic Humira to a biosimilar for the drug known as ABP 501.

Biosimilar: it’s all in the name

The trial put 152 patients on ABP 501 and 79 on Humira, comparing the effectiveness of the two drugs for a year. According to the data, results were similar for the two drugs. Comparable numbers of patients saw improvement, with about 85 percent of patients in both groups experiencing a 75 percent improvement in their psoriasis, and about 40 percent becoming completely clear.

Side effects were similar for the two groups too, according to researchers. About 86 percent of patients on the biosimilar, and about 79 percent of patients on the biologic, experienced a side effect. The most common side effects in both groups included headache, upper respiratory tract infection and the common cold.

The study was sponsored by Amgen, the company that makes ABP 501. Earlier this year, the FDA accepted Amgen's application to consider ABP 501 for approval. A decision is expected in the Fall.

Click here to read more about NPF’s efforts to regulate the use of biosimilars.



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