November 26th 2024
The phase 3 trial (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks.
Exploring Transthyretin-Mediated Amyloidosis and Its Phenotypes: A Comprehensive Approach to Patient Treatment
1.5 Credits / Cardiology, Neurology, Rare Diseases
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The Role of the Specialty Pharmacist in Optimizing Treatment for Amyotrophic Lateral Sclerosis: The Impact of ...
1.0 Credit / Neurology
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Advancing Targeted Therapies Aimed at Smoldering Disease in Multiple Sclerosis
1.0 Credit / Immunology, Neurology
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The Economics of Transthyretin-Mediated Amyloidosis: Balancing Equity and Access in Resource Allocation
1 Credit / Cardiology, Neurology
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Q&A With Dr Chelsee Jensen: Navigating FDA Approvals, Challenges in the Biosimilar Landscape
January 14th 2024Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the biggest FDA approvals of 2023 and how she sees the adalimumab, natalizumab, and tocilizumab spaces playing out.
EC Approves First MS Biosimilar; Coherus Receives CRL for Neulasta Onpro Competitor
September 27th 2023With the European Commission's (EC) approval of Tyruko, Europe receives its first natalizumab biosimilar and first biosimilar to treat multiple sclerosis (MS), while Coherus Biosciences received a complete response letter (CRL) for its biosimilar for Neulasta Onpro.
Regulatory Updates From Around the Globe Provide Hope for Biosimilars
September 9th 2023An approval in Australia and positive recommendations for 2 biosimilars in Europe bring hope for more affordable biologics around the world. However, another settlement for a US ustekinumab biosimilar showcases that some barriers remain.
IQVIA: Neurologists Are Excited for MS Biosimilars in Europe
April 5th 2023In IQVIA’s latest report, neurologists in Europe reported feeling positive about the biosimilars for multiple sclerosis (MS) coming down the pipeline, showing that industry-wide education efforts and experience with biosimilars are working to instill greater confidence in these products.
Comparable Safety, Efficacy Between First Proposed Natalizumab Biosimilar, Reference for MS
March 3rd 2023Phase 3 study findings support a proposed natalizumab biosimilar (PB006) as the first biosimilar alternative to reference natalizumab (Tysabri) for treatment of relapsing-remitting multiple sclerosis (MS).
Providers Exploit Minor Differences Between Innovator Drugs and Biosimilars
November 24th 2020Minute differences between biosimilars and reference products are not considered “clinically meaningful,” but these differences are exploitable when it comes to addressing allergies related to originator products.
Commentary Questions Differing Global Standards for MS Biosimilar Approvals
January 27th 2020A recently published commentary examines the global multiple sclerosis (MS) drug market from the perspective of patients and physicians, noting that different regulatory bodies have different standards in place for approvals, and questions if safety concerns are being addressed.
Low-Dose Rituximab May Be Cost-Effective for Myasthenia Gravis
December 28th 2019Autoimmune myasthenia gravis is typically treated with surgery, acetylcholine esterase inhibitors, corticosteroids, and immunosuppressive drugs like azathioprine and mycophenolate mofetil. Some patients have refractory disease and may require therapies like eculizumab (Soliris), which, while effective, is a particularly high-cost biologic that has no approved biosimilars in Europe or the United States, although biosimilars are advancing through clinical development. Rituximab, however, which is lower-cost than eculizumab and has multiple approved biosimilars, has also emerged as a promising treatment.
Retrospective Study of 56 Million Patients Shows Reduced Risk of Alzheimer With Anti-TNF Use
December 5th 2019Researchers from biotech company Tetra Therapeutics have reported that, in their retrospective population-based study of 56 million patients with inflammatory diseases, use of anti–tumor necrosis factor (anti-TNF) agents was linked with a reduced risk of Alzheimer disease.
At ANA 2019, Studies Detail the Role of Eculizumab in MG as Competitive Therapies Advance
October 14th 2019While eculizumab is being targeted by multiple biosimilar developers who are in phase 3 clinical trials with their competitive products, spending on eculizumab is reaching concerning levels; as such, it is increasingly important to clarify eculizumab’s place in the treatment paradigm for myasthenia gravis (MG).
Studies Report on Efforts to Optimize Rituximab in MS, NMOSD
September 21st 2019While rituximab does not carry indications for the treatment of multiple sclerosis (MS) or aquaporin-4-positive (AQP4) neuromyelitis optica spectrum disorder (NMOSD), the CD20-depleting therapy and its biosimilars are commonly used off-label, as the therapy has been demonstrated to be effective in reducing relapses in MS as well as in reducing the frequency and severity of attacks in NMOSD.
New Data From PREVENT Show Benefits of Eculizumab in NMOSD
September 13th 2019During this week’s meeting of the European Committee for Treatment and Research in Multiple Sclerosis, held September 11-13 in Stockholm, Sweden, researchers are presenting new data for eculizumab in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disorder that typically affects the optic nerves and spinal cord and that can cause significant, irreversible disability.
With a Biosimilar on the Horizon, New Data Give an Important Look at Natalizumab in MS
September 11th 2019Just last week, Sandoz indicated that it will commercialize a biosimilar of the multiple sclerosis (MS) drug natalizumab (Tysabri). This week, during the 35th meeting of the European Committee for Treatment and Research in Multiple Sclerosis, held September 11-13 in Stockholm, Sweden, researchers will present data that help contextualize natalizumab’s place in the treatment paradigm for MS.
Sandoz to Commercialize Biosimilar of MS Drug, Natalizumab
September 3rd 2019Sandoz, a Novartis division, announced today that it has entered into a global commercialization agreement with Poland-based Polpharma Biologics for a proposed natalizumab biosimilar referencing Biogen’s Tysabri. Natalizumab is a disease-modifying therapy used to treat relapsing-remitting multiple sclerosis (MS) as well as Crohn disease.
MS Experts in Latin America Publish Recommendations for Biosimilar Policies
June 3rd 2019With patents on reference products that treat multiple sclerosis (MS) set to expire soon in the region, a panel of experts in Latin America recently published a set of recommendations regarding the efficacy, safety, and quality of biosimilars in these countries.
Eculizumab Shows Positives Results in Cutting Relapses of Neuromyelitis Optica Spectrum Disorder
May 9th 2019A phase 3 trial of eculizumab found the drug reduced the frequency of relapse neuromyelitis optica spectrum disorder (NMOSD), an autoimmune, inflammatory disorder that typically affects the optic nerves and spinal cord.
Eculizumab May Allow Patients With MG to Reduce Immunosuppressive Therapy
May 2nd 2019The researchers wrote that that a numerically larger proportion of patients with myasthenia gravis (MG) stopped or reduced their doses of immunosuppressive therapies than started or increased, and that symptom improvement or worsening were the main reasons for changes to concomitant therapy.
Treating MS With Rituximab May Be Safe During Pregnancy and Breastfeeding
March 18th 2019Although rituximab does not carry an indication for the treatment of neurological disorders, the drug is widely used off-label as a therapy for B-cell–mediated disorders like multiple sclerosis (MS). Given the fact that rituximab has not been approved in these indications, however, data that reflect its safety and efficacy—particularly in patient populations for whom data are particularly scarce—are crucial.