Rare Disease

Trouble Ahead for Alexion's Biosimilar Defense Strategy?

November 23rd 2019

By Kelly Davio

Roche’s Japan-based subsidiary, Chugai Pharmaceutical, has filed a new patent infringement suit against Alexion in the District Court of Delaware.

Research Letter Suggests That Off-label Use May Be Boosting Eculizumab Sales

November 2nd 2019

By The Center for Biosimilars Staff

Article

In a research letter appearing this week in JAMA Internal Medicine, authors from Oregon Health and Science University raised the question of whether the “large and increasing revenue from eculizumab” could be tied to off-label use for non-approved indications.

As Biosimilars Emerge in Oncology and Rare Disease, Innovator Companies Look to New Drugs to Maintain Sales

October 17th 2019

By Kelly Davio

Article

As innovator biologics that have achieved blockbuster sales status reach or near the end of their exclusivities, biosimilar competition is close behind. This week, stakeholders got a closer look at how innovator drug companies are positioning themselves to maintain their sales in the face of such competition.

New Data Underscore the Utility of Rituximab in Treating Pemphigus Vulgaris

October 15th 2019

By Kelly Davio

Article

Genentech has announced that a phase 3 study of its brand-name rituximab, Rituxan, met its primary end point and demonstrated that treatment with rituximab is superior to treatment with mycophenolate mofetil in patients with moderate to severe pemphigus vulgaris (PV), a rate autoimmune disease that affects the skin and mucous membranes.

At ANA 2019, Studies Detail the Role of Eculizumab in MG as Competitive Therapies Advance

October 14th 2019

By The Center for Biosimilars Staff

Article

While 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).

Prime Therapeutics Study Shows Growth in Number of Drug "Super Spenders"

October 10th 2019

By The Center for Biosimilars Staff

Article

A small, yet rapidly growing segment of commercially insured US patients have drug costs of more than $250,000 each year, and this group could account for 15% of all drug expenditures in the next 5 years.

First Dornase Alfa Biosimilar Approved and Launched in Russia

September 21st 2019

By The Center for Biosimilars Staff

Article

This week, Russian drug maker Generium announced that it has received approval for—and has launched—its biosimilar dornase alfa in the Russian marketplace. Generium’s product is the first biosimilar dornase alfa biosimilar to be approved in any market worldwide.

New Data From PREVENT Show Benefits of Eculizumab in NMOSD

September 13th 2019

By Kelly Davio

Article

During 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.

European Patent Office Delivers Setback to Alexion on Soliris Patents

September 9th 2019

By Kelly Davio

Article

Last week, Alexion disclosed in a filing to the US Securities and Exchange Commission that the European Patent Office did not grant Alexion its request for 2 patents on its brand-name eculizumab product, Soliris, a C5 complement inhibitor that treats rare and ultrarare diseases.

Samsung Bioepis Begins Recruiting Patients for Phase 3 Trial of Eculizumab Biosimilar, SB12

August 16th 2019

By Kelly Davio

Article

Samsung Bioepis has begun recruiting patients with paroxysmal nocturnal hemoglobinuria (PNH) in India for a phase 3 clinical study of its proposed eculizumab biosimilar, SB12, referencing Soliris.