As reported by the Center for Biosimilars, a union has filed a class-action lawsuit against AbbVie and the eight prospective biosimilar adalimumab makers who agreed to delay bringing their agents to market through a royalty arrangement. Only Boehringer Ingelheim remains as a biosimilar maker who has an approved version of adalimumab but who has not … Continue reading Does Mass Signing of Adalimumab Licensing Deals Add Up to Biosimilar Access Collusion?
Tag: Cyltezo
Biosimilar Bytes
In the absence of really big biosimilar stories with far-reaching implications, let’s start with some interesting bits on biosimilars to begin this week. First, insulin maker Eli Lilly asked the Food and Drug Administration a very interesting question, in comments on the agency’s guidelines on transitional drugs. Lilly requested clarification of the rules under which … Continue reading Biosimilar Bytes
Rituximab Biosimilar Approved by FDA for Cancer Treatment
On November 28, 2018, the Food and Drug Administration (FDA) announced the approval of rituximab-abbs (Truxima™), produced by Celltrion and marketed by Teva. Approval for this rituximab biosimilar was overwhelmingly recommended by the FDA’s Oncology Drug Advisory Committee by a vote of 16-0 in October. It is the first biosimilar agent approved for the treatment … Continue reading Rituximab Biosimilar Approved by FDA for Cancer Treatment
Federal Policy and Biosimilars: A Conversation With Molly Burich, MS, Boehringer Ingelheim: Part 2
In part two and the conclusion of this interview, Molly Burich, MS, Director, Public Policy: Biosimilars and Pipeline, speaks to Boehringer Ingelheim's progress in Cytelzo interchangeability studies, its plans for the product in Europe in the face of several adalimumab biosimilars launches in the EU, and also the complexity inherent in CMS's plans to move biologic … Continue reading Federal Policy and Biosimilars: A Conversation With Molly Burich, MS, Boehringer Ingelheim: Part 2
Tidal Wave of Pegfilgrastim Biosimilars About to Hit Europe
We had mentioned the upcoming deluge of adalimumab biosimilars aiming to hit the European market in mid-October, but another biosimilar tidal wave may actually precede this. The European Medicines Agency (EMA) has had an extremely busy week in the pegfilgrastim biosimilars arena. In addition to granting marketing authorization to Coherus Biosciences for its pegfilgrastim biosimilar, … Continue reading Tidal Wave of Pegfilgrastim Biosimilars About to Hit Europe
Up to 5 Biosimilar Horses in the Race for Adalimumab in Europe: Heading for the Starting Gate
A long-sought dream in the United States will be a welcome reality in Europe this October: a stampede for Abbvie’s marketshare with adalimumab biosimilars and the savings that go with it. Four or possibly five manufacturers will be lined up in the starting gate. Fujifilm Kyowa Kirin Biologics and its marketing partner Mylan have not … Continue reading Up to 5 Biosimilar Horses in the Race for Adalimumab in Europe: Heading for the Starting Gate
With the Samsung Bioepis Deal, Abbvie Tightening Its Grip on the US Adalimumab Market
Samsung Bioepis and Biogen has reached a deal with Abbvie that would enable it to market its biosimilar adalimumab (should it be granted approval) in June 2023. This is the second deal Abbvie has made with a potential competitor, confirming the solidity of its patent wall. The European patent expires in October 2018, and competitors … Continue reading With the Samsung Bioepis Deal, Abbvie Tightening Its Grip on the US Adalimumab Market
FDA Approves New Humira Biosimilar, Bypasses Advisory Board Route
Boehringer Ingelheim Pharmaceuticals, Inc. announced August 29 that it had received approval from the Food and Drug Administration (FDA) for its first biosimilar. Named Cyltezo™ (adalimumab-adbm), a biosimilar to Humira®, it is approved for several autoimmune disorders, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease in adults, plaque psoriasis, and … Continue reading FDA Approves New Humira Biosimilar, Bypasses Advisory Board Route