- The Food and Drug Administration approved the first biosimilar to treat relapsing forms of multiple sclerosis.
- Tyruko (natalizumab), developed by international biotech company Polpharma Biologics, is a biosimilar to previously approved Tysabri.
- Both drugs are monoclonal antibodies that block a type of immune cell from crossing the blood-brain barrier, which reduces damage to nerve cells.
The Food and Drug Administration approved the first biosimilar to treat relapsing forms of multiple sclerosis this month. The drug is also approved as a treatment for adults with moderately to severely active Crohn’s Disease.
Tyruko (natalizumab), developed by international biotech company Polpharma Biologics, is a biosimilar to Biogen’s and Elan Corp.’s intravenous infusion drug Tysabri.
A biosimilar is a drug that is almost identical in structure and function as an already approved medication. The route of administration, dosage, and strength of both products are also the same.
“This biosimilar medication will allow for an additional multiple sclerosis treatment option which will potentially increase access for patients,” said Dr. David B. Duncan, neurologist and program director of the Comprehensive Multiple Sclerosis Center at Jersey Shore University Medical Center.
The approval of biosimilar Tyruko is based on a
“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.
MS is a disease that affects the brain, spinal cord, and optic nerves, which make up the central nervous system (CNS). The exact cause of MS is unknown.
However, scientists know that the disease occurs when the immune system mistakenly attacks the central nervous system, causing symptoms such as numbness, tingling, memory problems, mood changes, fatigue, pain, blindness and paralysis.
Most people with MS have episodes, called relapses, where new symptoms appear and their functioning worsens. These are initially followed by recovery periods.
Biosimilar Tyruko is approved to treat the following relapsing forms of MS:
- Clinically isolated syndrome: a single, first occurrence of MS symptoms;
- Relapsing-remitting disease: a type of MS that occurs when patients have episodes of new neurological symptoms followed by periods of stability
- Active secondary progressive disease: following a relapsing-remitting course, patients experience a gradual worsening of disability with ongoing relapses.
Natalizumab products (including Tyruko and Tysabri) are
The FDA’s prescribing information for natalizumab products contains a boxed warning about the increased risk of progressive multifocal leukoencephalopathy (PML), a viral infection of the brain that usually leads to severe disability or death.
Other warnings include an increased risk of herpes infection, low blood platelet count, certain types of infection, allergic reactions, and significant liver injury.
The most common side effects of natalizumab products are headache and fatigue. Other common side effects include joint pain, urinary tract infection, lower respiratory tract infection, gastrointestinal issues, infection or inflammation of the vagina, depression, pain in a limb, abdominal discomfort, diarrhea, and rash.
Dr. Sarah Yim, a director in the FDA’s Center for Drug Evaluation and Research said Aug. 24 in a
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.
For previously-approved Tysabri, the average cost of receiving the drug in the first year of treatment was more than $117,000, according to a study published earlier this year in the Journal of Medical Economics. The cost of the drug accounted for more than 78% of the total costs, researchers found.
Like Tysabri, biosimilar Tyruko is given by IV infusion every four weeks.
Because “biosimilars may be available at a lower cost than original biologics, this may improve insurance coverage and medication cost for patients,” Duncan told Healthline.
The price of Tyruko has not yet been released. Healthline reached out to Sandoz for comment but had not received a reply by the time of publication.
The actual cost of treatment with Tyruko will depend on a person’s insurance coverage and whether they are eligible for programs designed to reduce out-of-pocket costs.
Sandoz intends to enable access to Tyruko through its patient assistance program once the product is available, according to the National Multiple Sclerosis Society.
For more information on the program, call 1-833-4SANDOZ or visit www.us.Sandoz.com/PAP.
The FDA approved Tyruko (natalizumab), a biosimilar to previously approved Tysabri, as a treatment for relapsing forms of multiple sclerosis.
Biosimilars are almost identical in structure and function as an already approved medication.
The approval of Tyruko will increase competition in the prescription drug marketplace and may lower costs for patients.