Generic Version of Gilenya, pms-Fingolimod, Now Available for RRMS Patients in Canada

Patricia Inacio, PhD avatar

by Patricia Inacio, PhD |

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pms-Fingolimod launch

Pharmascience recently launched pms-Fingolimod, a generic version of Novartis’ Gilenya (fingolimod), to treat adults with relapsing-remitting multiple sclerosis (RRMS) in Canada. The new generic is now available in that country, and has demonstrated efficacy and safety similar to Gilenya.

Generic medicines are chemically identical to the original branded therapy, but carry a significantly lower cost.

“Pharmascience is proud to offer Canadian patients a therapeutic option that provides the same efficacy and safety as the brand name product. Our generic product is available at an affordable cost to the healthcare system, and is manufactured in Quebec,” Al Moghaddam, vice president and general manager of Pharmascience Canada, said in a press release.

“The launch of pms-Fingolimod reflects our corporate commitment to the Canadian community,” Moghaddam added.

In MS, immune cells called lymphocytes recognize the myelin sheath — the fat-rich substance that wraps around nerve fibers, and works to insulate and increase the velocity of the signals relayed by nerve cells — as foreign, causing inflammation and damaging this protective layer. Without myelin, nerve cells of the central nervous system (brain and spinal cord) start to die, a process known as neurodegeneration.

Fingolimod is an oral disease-modifying therapy that reduces exacerbations in RRMS patients by preventing the destructive action of immune cells against myelin.

At the molecular level, fingolimod is a modulator of the sphingosine 1-phosphate (S1P) receptor present on the surface of lymphocytes, which regulates when immune cells leave lymph nodes. By binding to this receptor, fingolimod prevents lymphocytes from leaving lymph nodes and invading the nervous system. In this way, it reduces both inflammation and neuronal damage.

The new generic, chemically similar to Gilenya, can now be obtained by Canadian patients. pms-Fingolimod capsules of 0.5 milligrams are approved to treat adult RRMS patients, and recommended for those who had an inadequate response or are unable to tolerate one or more MS therapies.

Similar to Gilenya, pms-Fingolimod also offers a patient support program to ensure an easy transition between therapies, called the Ally Patient Support Program. The program offers help with reimbursement, financial assistance, and a point of contact for ongoing support and information about this treatment.