Latest Conference Articles

Antitrust Issues Surrounding Biosimilars, Originator Products Not Going Away Anytime Soon

Allison Inserro

June 27 2019

Courts will be busy with biosimilar litigation for the foreseeable future, attorneys predicted at a panel on the second day of the ACI 10th Summit on Biosimilars.

What's New in the Biosimilar Labeling, Naming Landscape

Allison Inserro

June 26 2019

A panel at the ACI 10th Summit on Biosimilars focused on the recent FDA decision around the naming of biosimilar products and what that means for the industry, as well as related issues.

Comparing the Economics of Biosimilars and Generics

Allison Inserro

June 25 2019

The first set of presentations on day 2 of the ACI 10th Summit on Biosimilars on Tuesday in New York City reviewed the economics of biosimilar drugs and considerations for access, pricing, and reimbursement.

When Can Biologic Patent Disputes Go Before the ITC?

Allison Inserro

June 25 2019

Under which situations might the International Trade Commission (ITC) be the right choice for biosimilar patent disputes instead of federal district court? A panel discussed these questions at the ACI 10th Summit on Biosimilars on Monday in New York City.

Deputy Director Talks About Implementing Biosimilar Policy Within the FDA

Allison Inserro

June 24 2019

With a variety of policy ideas circulating around Washington, DC, in regards to stimulating biosimilar competition and lowering drug prices, the role of the FDA is to provide technical assistance to those legislative staffers and others looking for information, a key FDA official told a packed audience at the ACI 10th Summit on Biosimilars on Monday in New York City.

Interim Results From REFLECT Show No New Safety Concerns for Biosimilar Rituximab, Rixathon

Kelly Davio

June 20 2019

During last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, researchers presented their interim safety results from the REFLECT study, a prospective, noninterventional, observational, multicenter, open-label study of the biosimilar rituximab Rixathon as a curative therapy with cyclophosphamide, doxorubicin, vincristine, and prednisone in patients with previously untreated CD20-positive diffuse large B-cell lymphoma.

Real-World Data Reaffirm Biosimilar Filgrastim's Safety and Efficacy

Kelly Davio

June 19 2019

During the 24th European Hematology Association (EHA) Congress, researchers from the European branch of the Severe Chronic Neutropenia International Registry reported on experience with reference granulocyte colony-stimulating factor products and a biosimilar.

Celltrion Presents More Data Showing Comparable Efficacy, Safety of Subcutaneous CT-P13 to IV Form

Allison Inserro

June 19 2019

Korean drug maker Celltrion Healthcare recently presented new findings from a 2-part study at the European League Against Rheumatism European Congress of Rheumatology 2019 meeting about subcutaneous biosimilar CT-P13 (Inflectra, Remsima).

Four Studies Report Real-World Data on Biosimilar Rituximab, Truxima

Kelly Davio

June 18 2019

The FDA recently approved biosimilar rituximab CT-P10, or Truxima. While the drug is not yet available in the United States, data are accruing for its use in Europe. During last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, 4 groups of researchers reported on real-world data that support the use of the biosimilar in cancer care.

Amgen's Eculizumab Biosimilar, ABP 959, Shows PK, PD Bioequivalence to Soliris

The Center for Biosimilars Staff

June 18 2019

Amgen is developing a biosimilar of the drug, ABP 959, and during last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, researchers reported on findings from a phase 1 trial of the proposed product.