The FDA has approved the first biosimilar for the treatment of relapsing forms of multiple sclerosis.

Tyruko (natalizumab), developed by Polpharma Biologics, is a biosimilar to the previously approved medication Tysabri.

Tyruko and Tysabri are both monoclonal antibodies that inhibit the passage of a specific type of immune cell across the blood-brain barrier, thereby reducing nerve cell damage.

This approval also includes adults with moderately to severely active Crohn's disease.

Tyruko, for example, is a biosimilar that closely resembles an already approved medication in terms of structure, function, administration route, dosage, and sizing.

Dr. David B. Duncan, neurologist and program director of the Comprehensive Multiple Sclerosis Center at Jersey Shore University Medical Center said, “This biosimilar medication will allow for an additional multiple sclerosis treatment option which will potentially increase access for patients.”

The approval of biosimilar Tyruko is based on a phase 3 cliTrusted Sourcenical trial showing that it has “no clinically meaningful differences” from Tysabri, in terms of safety, purity, and potency, the FDA said in its release.

“In addition to having the same potential positive treatment effects, biosimilars are expected to have the same potential risks and side effects,” Duncan told Healthline.

“The production facility where the biosimilar is manufactured, processed, packed, and held must also meet the same standards as the one where the original medication is manufactured,” he said, “to ensure that it continues to be safe, potent, and pure.”

Healthcare company Sandoz Inc., in collaboration with Polpharma Biologics, will make the drug available to patients in the United States.

Dr. Sarah Yim, a director in the FDA’s Center for Drug Evaluation and Research said Aug. 24 in a releaseTrusted Source that biosimilar products may encourage competition in the drug marketplace and help “increase access to safe, effective and high-quality medications at potentially lower cost.”

Bari Talente, executive vice president for advocacy and healthcare access at the National MS Society, called the FDA approval of biosimilar Tyruko a “milestone.”

“Access to affordable, high-quality healthcare is essential for people with multiple sclerosis to live their best lives,” she said in a release.

A recent study found Tysabri treatment cost over $117,000 in the first year, 78% of total costs.

Biosimilar Tyruko, given by IV infusion, could be a cheaper option, potentially improving insurance coverage.

Tyruko’s price is unknown; Sandoz’s plans include patient assistance once available, per the National MS Society.