Practice

Fresenius Kabi Submits Adalimumab Biosimilar Marketing Application to EMA

December 19th 2017

By Samantha DiGrande

Fresenius Kabi, a subsidiary of the German-based Fresenius SE and Co. KFaA, announced yesterday that its Marketing Authorization Application for MSB11022, an adalimumab (Humira) biosimilar candidate, was submitted and accepted for review by the European Medicines Agency (EMA).

The Journey of Biosimilar Epoetin Alfa Serves as Example of Approval Pathway Integrity

December 18th 2017

By Jackie Syrop

Article

Frank Dellanna, MD, and colleagues reviewed the journey of HX575 from development to approval in Europe, and describe a decade of clinical experience in patients with CKD, as the history and experience with this biosimilar provides an excellent example of a successful demonstration of biosimilarity.

The Top 5 Biosimilars Articles for the Week of December 11

December 15th 2017

By The Center for Biosimilars Staff

Article

The Center for Biosimilars® recaps the top 5 articles for the week of December 11.

Study: Starting Dose, Cumulative Dose Do Not Predict Rituximab Adherence in RA

December 14th 2017

By Samantha DiGrande

Article

A recently published study explored the impact of 2 different initial doses and a cumulative 2-year dose of rituximab on drug adherence and predictors of adherence to treatment in patients with RA in an observational clinical setting.

Measuring Antibodies to Infliximab To Guide Treatment Intensification in Crohn Disease

December 14th 2017

By Jackie Syrop

Article

A significant proportion of patients with Crohn disease (CD) who initially respond to infliximab therapy experience secondary loss of response with symptom flares. Treatment intensification (using increases in dose, dose frequency, or a combination of both to implement intensification) is a suggested strategy for regaining response.

Roche May Defend Rituximab, Bevacizumab Sales With New Drug Combinations

December 13th 2017

By Kelly Davio

Article

Roche has announced positive data on 2 of its innovator oncology biologics in combination with other therapies. The combinations using rituximab (MabThera, Rituxan) and bevacizumab (Avastin) could help the Swiss drug maker to protect sales of these monoclonal antibodies in the face of oncoming biosimilar competition.

Infliximab Shows Promise in Treating Retinal Disorders

December 12th 2017

By Kelly Davio

Article

A recent study examined whether the use of the anti–tumor necrosis factor agent infliximab could reduce the death of photoreceptors after retinal detachment in an experimental mouse model.

Down-Titration of Biologics May Be an Option For Patients With RA

December 8th 2017

By Kelly Davio

Article

A recently published systematic literature review sought to compare the effects of down-titration of biologics compared with standard dosing on clinical efficacy and health-related quality of life, and to evaluate the impact of decreased doses on the cost of RA treatment.

The Top 5 Biosimilars Articles for the Week of December 4

December 8th 2017

By The Center for Biosimilars Staff

Article

The Center for Biosimilars recaps the top 5 articles for the week of December 4.

High Cost Sharing Associated With Lower Rates of Cancer Treatment Initiation, Study Finds

December 8th 2017

By Kelly Davio

Article

Advances in research have led to increased therapeutic options for patients with cancer, but these drugs come at a substantial cost; high out-of-pocket costs pose a significant barrier to treatment initiation for patients with cancer, according to a new, retrospective claims-based study.