Regulatory

European Commission Approves Alexion's Ravulizumab for PNH

July 3rd 2019

By The Center for Biosimilars Staff

The European Commission approved ravulizumab (Ultomiris) for adults with paroxysmal nocturnal hemoglobinuria.

The Top 5 Biosimilars Articles for the First Half of 2019

July 3rd 2019

The Center for Biosimilars® recaps the 5 most-read stories of 2019 to date.

Attorneys, Others Discuss Current Trends in Biosimilar Development

June 28th 2019

By Allison Inserro

Industry insiders discuss current trends about the patent dance and other issues, as well as proposed legislation that could affect biosimilar development.

FDA Approves Pfizer's Bevacizumab Biosimilar, Zirabev

June 28th 2019

By Kelly Davio

The FDA has approved Pfizer’s bevacizumab biosimilar, bevacizumab-bvzr, referencing Avastin.

The Top 5 Biosimilars Articles for the Week of June 24

June 28th 2019

The Center for Biosimilars® recaps the top stories for the week of June 24, 2019.

FDA Approves Alexion's Eculizumab for Neuromyelitis Optica Spectrum Disorder

June 28th 2019

By The Center for Biosimilars Staff

Alexion Pharmaceuticals’ brand-name eculizumab (Soliris) gained its fourth approval, this time for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

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

June 27th 2019

By Allison Inserro

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.

FDA Announces Proposed Rule to Aid in Products' Transition to Biologics and Biosimilars

June 27th 2019

By The Center for Biosimilars Staff

The FDA today announced a proposed rule that would amend regulations concerning the use of master files for biologics. According to the FDA, this rule is necessary to avoid any disruption to products that will transition from regulation as drugs to regulation as biologics in 2020.

Lilly and Innovent's Biosimilar Rituximab to Be Reviewed by China's Regulators

June 27th 2019

By The Center for Biosimilars Staff

Eli Lilly and Company, together with partner Innovent Biologics, announced today that China’s National Medical Products Administration will review its application for IBI301, a proposed rituximab biosimilar referencing MabThera and Rituxan.

Biosimilars Council White Paper Condemns Patent Abuses, Defends Patent Settlements

June 27th 2019

By Kelly Davio

The Biosimilars Council, a part of the Association for Accessible Medicines, has issued a new white paper in which it condemns abuses of the patent system that delay biosimilar competition. It also argues that legislative proposals to regulate settlements would “merely benefit companies investing in the creation of patent thickets.”