Kelly Davio

April 20, 2019

This week, the FDA granted priority review to Novartis’ innovator biologic, RTH258, brolucizumab. The vascular endothelial growth factor (VEGF) inhibitor is intended to treat wet age-related macular degeneration.

April 19, 2019

The authors write that these data add to the totality of the evidence supporting the biosimilarity of the biosimilar infliximab with its reference.

April 18, 2019

This month, US magistrate judge Richard A. Lloret granted Boehringer Ingelheim (BI)’s motion to compel AbbVie to produce prelitigation disclosures and settlements concerning its brand-name adalimumab, Humira.

April 18, 2019

Yesterday, the European Parliament approved a proposal to allow waivers of supplementary protection certificates (SPCs) for EU generics and biosimilars by a vote of 572 to 36.

April 17, 2019

According to The International Generic and Biosimilar Medicines Association (IGBA)’s paper, despite global progress in strengthening the regulatory system for medicines, progress related to biologics and biosimilars has been less robust.

April 17, 2019

Magellan Rx Management, a pharmacy benefit manager (PBM), said today that its biosimilar management program has resulted in strong biosimilar uptake and significant drug cost savings for health plan organizations during its first year.

April 16, 2019

The new assessment, says the Institute for Clinical and Economic Review (ICER), is intended to incorporate data that have emerged since the organization reviewed rheumatoid arthritis (RA) treatments in 2017, including data related to biosimilar infliximab, Inflectra.

April 15, 2019

Last week, Health Canada approved Celltrion and Teva’s biosimilar rituximab, Truxima, for the treatment of adults with non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

April 15, 2019

A new paper describes the process of assessing the analytical and functional similarity of EU- and US-licensed reference trastuzumab and Amgen's ABP 980, Kanjinti.

April 10, 2019

Nordic countries with highly competitive public tenders are among the markets that have seen the greatest success with adopting biosimilars and reaping their cost-saving rewards. Yet Sweden, unlike its neighbors, has decentralized healthcare budgets and policies in its 21 county councils, and has seen more variable uptake of biosimilars.