Sandoz Glatopa® demonstrates trend towards lower relapse rates and costs for MS patients in US compared to originator medicine in real-world study
May 13, 2020
Sandoz Inc. today announced results from a US real-world analysis showing that people living with multiple sclerosis (MS) who were treated with Glatopa® (glatiramer acetate injection) 20 mg experienced similar health outcomes and costs, with a trend towards lower relapse rates and cost savings, compared to those treated with Teva’s Copaxone®* (glatiramer acetate injection) 20 mg.
This study is the first to examine the real-world health outcomes and cost impact of switching patients from brand to generic glatiramer acetate injection, and has been published in the current issue of Current Medical Research & Opinion.1
“In addition to reinforcing the comparable effectiveness of Glatopa to Copaxone® in the real-world, this study highlights the significant US cost reduction (~75%) for glatiramer acetate injection therapy in the five years since the introduction of Glatopa and other generics,” said study author Steven B. Hall, Pharm.D., Executive Director and Head, Differentiated Products Medical Affairs at Sandoz. “Glatopa is just one example of Sandoz ongoing commitment to help patients access high-quality medicine at a more affordable price while contributing to a sustainable healthcare system.”
Glatiramer acetate injection medicines account for approximately one-third of MS disease modifying therapy prescriptions.1 As of November 2019, Glatopa has the lowest wholesale acquisition cost (WAC) of all glatiramer acetate injection medicines available to people living with MS in the US.2
The retrospective claims study compared MS relapse rates and treatment costs of more than 300 patients with relapsing forms of MS who were treated with either Glatopa 20 mg or Copaxone® 20 mg. A trend towards lower relapse rates and cost savings was observed in patients treated with Glatopa, but the differences were borderline statistically significant and not statistically significant, respectively. Patient data was drawn from the HealthCore Integrated Research Database® from 2013 to 2018.
MS is a chronic disorder of the central nervous system that affects around 400,000 people in the US.3 In addition to the personal burden of MS for patients and families, affordability is a significant challenge for MS patients globally. Glatopa was the first FDA-approved, fully substitutable, AP rated generic version of the originator brand-name medicine.
Glatopa® Indication and Important Safety Information
Glatopais indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Important Safety Information
Do not take Glatopa if you are allergic to glatiramer acetate, mannitol, or any of the ingredients in Glatopa.
Some patients report a short-term reaction right after or within minutes after injecting glatiramer acetate. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain, fast heartbeat, anxiety, and trouble breathing. These symptoms generally appear within seconds to minutes of an injection, last about 15 minutes, and do not require specific treatment. During the postmarketing period, there have been reports of patients with similar symptoms who received emergency medical care. If symptoms become severe, call the emergency phone number in your area. Call your doctor right away if you develop hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at the injection site. If any of the above occurs, do not give yourself any more injections until your doctor tells you to begin again.
Chest pain may occur either as part of the immediate post-injection reaction or on its own. This pain should only last a few minutes. You may experience more than one such episode, usually beginning at least one month after starting treatment. Tell your doctor if you experience chest pain that lasts for a long time or feels very intense.
A permanent indentation under the skin (lipoatrophy) or, rarely, necrosis at the injection site may occur, due to local destruction of fat tissue. Be sure to follow proper injection technique and inform your doctor of any skin changes.
The most common side effects in studies of glatiramer acetate injection are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. These are not all of the possible side effects of glatiramer acetate. For a complete list, ask your doctor or pharmacist. Tell your doctor about any side effects you have while taking Glatopa.
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.