Business

European Medicines Agency Authorizes Marketing of Pfizer's Ruxience

January 31st 2020

By Gianna Melillo

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization for Pfizer's Ruxience, a rituximab biosimilar.

Vizient Says It Supports FDA Plan for Insulin Biosimilars, Interchangeable Insulins

January 29th 2020

By The Center for Biosimilars Staff

Article

The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.

Industry Executive Warns International Pricing Index Could Slow Drug Investment

January 24th 2020

By Tony Hagen

Article

Molly Burich, MS, director of public policy for biosimilars and pipeline at the pharmaceutical giant Boehringer Ingelheim, discussed the International Price Index proposal Thursday at the 2020 Specialty Therapies and Biosimilars Congress in Miami, Florida.

Pfizer Touts Lower WAC of 3 Oncology Biosimilars as It Launches Rituximab Product

January 24th 2020

By The Center for Biosimilars Staff

Article

Pfizer said it expects its 3 oncology biosimilar products to have the lowest wholesale acquisition cost among currently available bevacizumab, rituximab, or trastuzumab biosimilars. Its latest, Ruxience, referencing Rituxan, launched Thursday.

Sputtering Cost Reforms May Gain Momentum in 2020, but Patients Will Still Carry Higher Burden

January 23rd 2020

By Tony Hagen

Article

In a wide-ranging state-of-the-industry talk, the clinical operations manager for Blue Cross Blue Shield of Michigan discussed pending legislation, electronic prior authorization (ePA), and biosimilar uptake, among other prominent issues Wednesday at the 2020 Specialty Therapies and Biosimilars Congress in Miami, Florida.

Biosimilar Makers Must Plan for Originator Firms Gaming the Patent System, Panel Says

January 22nd 2020

By Tony Hagen

Article

It’s important to keep in mind the successive patents that can be filed to keep an original product in a position of market dominance, and drug descriptions in biologic license applications can be written cleverly to achieve this aim, according to a panelist speaking at the Specialty Therapies and Biosimilars Conference, happening January 22-24, 2020, in Miami, Florida.

Nonprofit Payer Says It Saved $1.7 Million Through Use of Infliximab Biosimilars

January 22nd 2020

By The Center for Biosimilars Staff

Article

Health New England says it achieved 93% utilization by requiring prior authorization.

Celltrion Amps Up Its Biosimilar Launch Schedule

January 22nd 2020

By Tony Hagen

Article

The company's announcement of an aggressive launch calendar at the JP Morgan Healthcare Conference in San Francisco last week was followed by Celltrion’s announcement this week that it plans to open a large biologics manufacturing plant in Wuhan, China.

The Biosimilar Solution to Expensive Cancer Care

January 20th 2020

By Maggie L. Shaw

Article

In May 2019, the FDA released its final guidance on biosimilars. With more and more oncology biosimilars entering the market, healthcare providers should be able to help their patients reduce their out-of-pockets costs while providing the highest-quality care available, which will lead to savings over time, according to a recent column in Evidence-Based Oncology™, a sister publication to The American Journal of Managed Care®.

JAMP Pharma Licenses 5 Biosimilar Candidates From Alvotech for Canadian Market

January 17th 2020

By The Center for Biosimilars Staff

Article

The current market value of the branded sales for these biosimilars is estimated to exceed $2 billion annually, the companies said.