The multitude of companies that have lined up to sign 2023 licensing agreements with Abbvie on sales of Humira® biosimilars has grown again. The latest biosimilar maker added to the list is Coherus Biosciences. Coherus has an investigational adalimumab biosimilar that completed a phase 3 trial in 2017 in patients with plaque psoriasis and psoriatic … Continue reading More Adalimumab News: Abbvie Signs a Licensing Deal With Coherus, Coherus Sues Amgen for Patent Infringement
Tag: Amgen
An Update on Potential Biosimilars for Bevacizumab
Embroiled in patent litigation, the partnership of Amgen and Allergan have waited for the opportunity to launch Mvasi® since September 2017. During this time, the competition has not been stagnant, with Pfizer moving towards an FDA decision. The next 6 months may prove critical, but when will providers, patients, and payers have access to Avastin® … Continue reading An Update on Potential Biosimilars for Bevacizumab
Pfizer Pulls One Biosimilar Adalimumab Application From the EMA
Earlier this month, Pfizer notified the European Medicines Agency (EMA) that it was withdrawing one of its two applications for approval of its biosimilar adalimumab. According to Pfizer's Director of Global Media Relations, Thomas Biegi, the company had submitted two applications for this biosimilar, one for a limited set of indications, and the other for … Continue reading Pfizer Pulls One Biosimilar Adalimumab Application From the EMA
Pfizer Signs Licensing Agreement With Roche on Trastuzumab Biosimilar
With Pfizer expecting to hear back on its 351(k) resubmission on a trastuzumab biosimilar in early 2019, Genentech and its parent, Roche, may have been getting nervous about their competitor’s intentions. After all, Pfizer was willing to launch at risk with its marketing of Inflectra®, the infliximab biosimilar manufactured by partner Celltrion. In fact, it … Continue reading Pfizer Signs Licensing Agreement With Roche on Trastuzumab Biosimilar
Amgen Withdraws Membership From Biosimilars Advocacy Group
Journalist Dan Stanton reported that Amgen withdrew in September from The Biosimilars Forum, based on disagreements with the remaining eight biosimilar-manufacturing members and perhaps internal conflicts within Amgen. Founded by 11 members (Allergan, Amgen, Boehringer Ingelheim, Coherus BioSciences, EMD Serono, Epirus Biopharmaceuticals, Merck and Co., Pfizer, Samsung Bioepis, Sandoz, and Teva), 8 now remain (B-I, … Continue reading Amgen Withdraws Membership From Biosimilars Advocacy Group
Pfizer Launches Retacrit, First Biosimilar Version of Epogen and Procrit
On November 13, Pfizer began marketing its biosimilar version of epoetin alfa. Pfizer launches Retacrit® at a 33.5% discount to Amgen’s reference product Epogen®. Retacrit was originally developed by Hospira, which Pfizer acquired in 2015. Retacrit was one of the first biosimilars approved in the EU. It had a long journey to reaching the market in … Continue reading Pfizer Launches Retacrit, First Biosimilar Version of Epogen and Procrit
Momenta Signs Licensing Deal With Abbvie. Did It Have a Choice?
We previously reported that Momenta Pharmaceuticals reevaluated its biopharmaceutical strategy going forward, deciding to move forward only with its investigational adalimumab and aflibercept biosimilars. Yesterday, Momenta announced that it has joined the long queue of pharmaceutical manufacturers signing a biosimilar licensing deal with Abbvie, which will allow commercialization of M923, its biosimilar to Humira, should … Continue reading Momenta Signs Licensing Deal With Abbvie. Did It Have a Choice?
Coherus Gets FDA Approval for Its Pegfilgrastim Biosimilar
With the Food and Drug Administration (FDA) approval today of Coherus Bioscience’s Udenyca™ (pegfilgrastim-cbqv), the second pegfilgrastim to compete with Amgen’s Neulasta®, much attention will be now focused on the company’s November 8 earning call. The FDA approved Udenyca on the basis of a supportive analytical similarity package, but with phase 1 data only. Over 600 … Continue reading Coherus Gets FDA Approval for Its Pegfilgrastim Biosimilar
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