FDA Approves First Multiple Sclerosis Biosimilar, Sandoz’s Tyruko

The FDA recently approved the first biosimilar for the treatment of multiple sclerosis (MS): Tyruko (natalizumab-sztn) from Novartis Pharmaceutical Corp. subsidiary Sandoz Inc. The drug is entering a fairly crowded class, and payers have said they expect it to have a moderate impact on their management of the other agents available to treat the condition.

On Aug. 24, the FDA approved Tyruko for the treatment of two indications: (1) adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease, and (2) adults with moderately to severely active Crohn’s disease with evidence of inflammation who have had an inadequate response to, or are unable to tolerate, conventional Crohn’s therapies and tumor necrosis factor (TNF) inhibitors.

It is the first FDA-approved biosimilar of Biogen’s Tysabri (natalizumab). The FDA first approved that integrin receptor antagonist via accelerated approval on Nov. 23, 2004, for relapsing forms of MS to reduce the frequency of clinical relapses. On Jan. 14, 2008, the agency approved it for moderately to severely active Crohn’s.

However, only four months after Tysabri’s initial approval, then-manufacturers Biogen Idec, Inc. and Elan Corp. pulled the drug from the market after two people taking it developed progressive multifocal leukoencephalopathy (PML), a rare and often fatal brain infection.

On June 5, 2006, the FDA approved the drug’s return to the market with a Risk Minimization Action Plan (RiskMAP) — now known as a Risk Evaluation and Mitigation Strategy (REMS) — warning about the risk of PML and requiring that providers monitor patients per a certain schedule and that prescribers, patients and infusion centers and pharmacies providing Tysabri be enrolled in the TOUCH Prescribing Program, among other things.

Tyruko will similarly be available through the Sandoz REMS program.

Dosing for the drugs is 300 mg via a 60-minute intravenous infusion every four weeks. Drugs.com lists the price of a 300 mg/15 mL single-dose vial of Tysabri as more than $8,653.

For the Managed Care Biologics & Injectables Index: Q1 2023, from Feb. 27, 2023, to March 26, 2023, Zitter Insights polled 36 commercial payers covering 117.6 million lives, 25 Medicare payers representing 40.3 million lives and 50 neurologists about their management and prescribing of MS therapies, including the anticipated impact of Tyruko. Payers with more than three-quarters of covered commercial lives and those with almost all Medicare beneficiaries said they were either somewhat or moderately aware of Tyruko. Almost 40% of neurologists responded similarly.

Both AIS Health and Zitter Insights are divisions of MMIT.

Payers covering almost half of both commercial and Medicare lives said they expect the new drug to have a moderate impact on other MS agents (see chart). Almost half of neurologists stated that they expect Tyruko to have some impact on their approach to treating people with MS, meaning that they anticipate their approach will remain mainly unchanged, although it may differ somewhat with certain new and current patients.

For more information on the Zitter Insights data, contact Jill Brown Kettler at jkettler@mmitnetwork.com.