Practice

ISOPP Releases Position on Biosimilars, Voices Opposition to Treating Biosimilars as Interchangeable

October 11th 2019

By Kelly Davio

The International Society of Oncology Pharmacy Practitioners (ISOPP), which convened in London, United Kingdom, this week for its 18th international symposium on oncology pharmacy practice, has issued a new global position statement on biosimilars in therapeutic and supportive oncology.

Samsung Bioepis' Etanercept Biosimilar Performs in Real-World Treatment of Psoriasis

October 9th 2019

By Kelly Davio

Article

In treating patients with moderate to severe psoriasis, Samsung Bioepis’ etanercept biosimilar, approved in the European Union as Benepali and in the United States as Eticovo, was shown to be effective in a registry study.

Pediatric Patients and Their Families Report Unique Concerns When It Comes to Biosimilar Switching

October 7th 2019

By Kelly Davio

Article

According to the authors, while many anticipated that most major concerns about the switch to biosimilar adalimumab would relate to safety and efficacy, more prevalent concerns were related to device type, the presence of a citrate, or the color of the product.

Novartis to Seek a Fourth Indication for Secukinumab

October 2nd 2019

By The Center for Biosimilars Staff

Article

Drug maker Novartis announced that it will seek a fourth indication—nonradiographic axial spondyloarthritis (nr-axSpA)—for its secukinumab (Cosentyx) in the United States after its phase 3 PREVENT trial met its 52-week primary end point.

COA Issues Policy Statement on Step Therapy in Cancer Care

October 1st 2019

By Allison Inserro

Article

Step therapy, which requires that patients try the payer’s preferred treatment before the one a physician recommends, jeopardizes the health of patients with cancer by delaying treatment and creating unnecessary barriers, according to a recent position statement from the Community Oncology Alliance (COA).

ESMO 2019 Features Data on Biosimilar Pegfilgrastim and Filgrastim

September 30th 2019

By Kelly Davio

Article

During the European Society for Medical Oncology (ESMO) Congress 2019, researchers provided a detailed look at a 3-treatment, 6-sequence crossover study for a pegfilgrastim biosimilar, and a separate team presented on the use of biosimilar filgrastim in patients who are being given chemotherapy regimens that involve a rest period of up to 14 days.

Biogen Director Shares Lessons Learned From EU Biosimilar Commercialization

September 25th 2019

By Kelly Davio

Article

During the opening day of the SMi 10th Annual Biosimilars Conference, held September 25-26 in London, United Kingdom, Dan Cohen, Biogen’s regional senior director of biosimilars for the United Kingdom, Ireland, and the Netherlands, shared his experience with anti–tumor necrosis factor biosimilars in general, and with biosimilar adalimumab in particular, in the EU marketplace.

FDA Releases Biosimilar Educational Materials for Patients

September 23rd 2019

By The Center for Biosimilars Staff

Article

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

Article

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

Article

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.