Practice

FDA Releases Biosimilar Educational Materials for Patients

September 23rd 2019

By The Center for Biosimilars Staff

Today, the FDA released a new suite of resources to educate patients about biosimilars.

Celltrion Receives Positive CHMP Opinion for Subcutaneous Infliximab Biosimilar, CT-P13

September 23rd 2019

By Kelly Davio

During its September 2019 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending a change to Celltrion’s marketing authorization for its biosimilar infliximab, CT-P13, sold in Europe as Remsima.

Studies Report on Efforts to Optimize Rituximab in MS, NMOSD

September 21st 2019

By Kelly Davio

While 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.

Vial Sharing for Bevacizumab in Treating Eye Disorders Reduces Costs, Increases Access

September 18th 2019

By Kelly Davio

Vial sharing for bevacizumab that would otherwise have been discarded yielded a 97.88% reduction in the total cost of a single year of intravitreal injections, as well as a 96.54% increase in the number of injections performed.

A Decade of Biosimilar Filgrastim Experience Highlights the Scientific Basis for Extrapolation, Study Says

September 17th 2019

By Kelly Davio

Sandoz’s biosimilar filgrastim was first approved in Europe in 2009 under the name Zarzio (later, the same drug was approved as Zarxio in the United States). Since that time, the number of biosimilars approved for use in the oncology field has grown substantially, and a recent review says that the past decade of experience with biosimilar filgrastim underscores the strong scientific basis for the extrapolation of indications for biosimilars.

Step Therapy in RA or PsA Leads to Worse Treatment Outcomes, Study Says

September 16th 2019

By Allison Inserro

A recent study says step therapy in rheumatoid (RA) or psoriatic arthritis (PsA) can hurt treatment outcomes.

Patients With Rheumatic Diseases Face Substantial Hurdles in Accessing Treatment, ACR Says

September 16th 2019

By Kelly Davio

While it is well understood that timely access to treatment is key for the management of rheumatic diseases, respondents to The American College of Rheumatology (ACR) 2019 Rheumatic Disease Patient Survey reported difficulty accessing and paying for their therapies in the past year.

The Top 5 Biosimilars Articles for the Week of September 9

September 13th 2019

The Center for Biosimilars® recaps the top stories for the week of September 9, 2019.

With a Biosimilar on the Horizon, New Data Give an Important Look at Natalizumab in MS

September 11th 2019

By Kelly Davio

Just 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.

Patients With IBD Upset With British Columbia Switching Program

September 10th 2019

By The Center for Biosimilars Staff

Patient organizations for those with inflammatory bowel disease (IBD) are upset with the government of British Columbia for a plan to shift patients to biosimilars over the next 6 months.