Biosimilar Drugs

Biosimilars can be confusing new territory for rheumatoid arthritis patients.

Now, thanks to newly proposed naming policies that will be designated and enforced by the Food and Drug Administration (FDA), people with rheumatoid arthritis (RA) will know exactly what kind of drugs they are getting.

In a move applauded by many patient advocacy organizations, including the American College of Rheumatology, the FDA requires separate and distinctive names when it comes to biosimilar and biologic drugs.

The new draft guidance ensures that pharmaceutical companies will follow regulations and remain compliant when it comes to the naming and marketing of biosimilar medications.

The draft, entitled Nonproprietary Naming of Biological Products: Guidance for Industry, contains regulatory information and can be read in full here.

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What the Guidelines Say

The draft guidance follows a previously issued position statement, as well as several comment letters from the American College of Rheumatology (ACR) to the FDA.

Those letters called for transparency and patient safety.

RA Biosimilars

The concern was the possibility that biosimilars could be substituted for biologics without the consent or knowledge of patients.

In a statement issued by the ACR, the organization expressed their agreement with the FDA’s new naming guidelines.

“The ACR commends the FDA’s proposal to require distinctive names for biosimilar drugs and original biologics,” said Dr. Doug White, the chairman of the ACR’s Committee for Rheumatologic Care.

He also stated that “Distinctive names will allow for greater transparency in substitution and notification, making it clear to all parties involved—pharmacists, providers, and patients—which drug the patient is receiving.”

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New Rules Will Help Patients

The transparency and clarity surrounding biologics versus biosimilars is a change that is poised to help patients better embrace and understand the care that they are given.

The move could also possibly build trust between doctors, patients, and pharmaceutical drug companies.

“The FDA’s proposal to require distinguishable names for biosimilars will help rheumatologists and other specialists ensure patients continue to receive breakthrough therapies that are both clinically appropriate and effective without compromising their health or safety,” said White.

Some patients may still be skeptical. Nonetheless, many are hopeful about the new possibilities for RA treatment that biosimilar drugs may provide.

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