On December 6, 2019, the US Food and Drug Administration (FDA) gave Amgen its approval to market the fourth biosimilar infliximab medicine. Dubbed Avasola (infliximab-axxq), a launch date was not announced, but one can assume that Amgen intends to launch this agent as soon as possible. This infliximab biosimilar was approved for all of the … Continue reading Amgen’s Infliximab Biosimilar, Avasola, Receives FDA Approval
Tag: Amgen
Biosimilar Bytes This Week
The Institute for Clinical and Economic Review (ICER) released a report this week that highlighted seven pharmaceuticals with “substantial price increases on top of already high current spending.” According to ICER, these seven agents accounted for billions in unnecessary expense in 2017 and 2018. AbbVie’s Humira® and Genentech’s Rituxan® topped the list, with Neulasta® coming … Continue reading Biosimilar Bytes This Week
Multiple Sources Announce Pfizer’s Intended Launch of Bevacizumab Biosimilar December 31, 2019
After coming to a settlement agreement (which may have been prodded by Amgen’s launch of Mvasi® in July), Pfizer can launch Zirabev® at the end of this year. First reported by Aiden Fry at The Pink Sheet and confirmed by Kelly Davio at the Center for Biosimilars, the settlement between Genentech and Pfizer was signed … Continue reading Multiple Sources Announce Pfizer’s Intended Launch of Bevacizumab Biosimilar December 31, 2019
The Potential Effect of Amgen’s Launch on Biosimilar Licensing Deals
Imagine this interesting and perhaps very real-life scenario. It could have several implications for the present biosimilar marketing picture. A reference manufacturer, we’ll call them Arby, signs multiple licensing deals with biosimilar manufacturers, to launch their products sequentially in 2025. The licensing deals all conclude outstanding patent litigation between the parties. But one biosimilar manufacturer … Continue reading The Potential Effect of Amgen’s Launch on Biosimilar Licensing Deals
Amgen/Allergan Partners Announce Launches of Herceptin and Avastin Biosimilars
The partnership of Amgen and Allergan made a huge splash in the biosimilar market by announcing the simultaneous US launches of the first two biosimilars of anticancer monoclonal antibodies. The agents Kanjinta® (trastuzumab-anns) and Mvasi® (bevacizumab-awwb) were officially made available July 18. The move occurred almost simultaneously with a court denial of Genentech’s request for … Continue reading Amgen/Allergan Partners Announce Launches of Herceptin and Avastin Biosimilars
A Profile on Lesser-Known Player in the Biosimilar Space: Formycon AG
On occasion, we profile some biosimilar manufacturers about whom our readers may not be as familiar as the large players like Sandoz, Amgen, and Pfizer. This generally refers to companies that have products that are in earlier-stage research or those who simply have not been in the news as often as their colleagues. In this … Continue reading A Profile on Lesser-Known Player in the Biosimilar Space: Formycon AG
Introducing the 21st FDA Approval: Pfizer’s Zirabev, a Biosimilar of Avastin
On June 28, 2019, Pfizer announced that it had received Food and Drug Administration (FDA) approval of Zirabev™ (bevacizumab-bvzr), a biosimilar version of Roche’s Avastin®. Based on the evidence provided by Pfizer, including its phase 3 trial comparing it to the EU-licensed version of Avastin, the FDA approved Zirabev for five cancer indications, including: Advanced, … Continue reading Introducing the 21st FDA Approval: Pfizer’s Zirabev, a Biosimilar of Avastin
Don’t Expect All-Out Biosimilar Competition for Herceptin—Just Yet
Five trastuzumab biosimilars have been approved for marketing in the US, and the composition-of-matter patent for the reference product, Herceptin®, expires June 30, 2019. That doesn’t mean we’ll see a jail break of competition, like that seen in the EU last October with adalimumab’s patent expiration. Yet there has been heavy interest in capturing a … Continue reading Don’t Expect All-Out Biosimilar Competition for Herceptin—Just Yet
Does Mass Signing of Adalimumab Licensing Deals Add Up to Biosimilar Access Collusion?
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?
A Conversation With Doug Long, IQVIA
Doug Long, Vice President of Industry Relations at IQVIA (formerly QuintilesIMS), spoke with us about some of the intracacies of the filgrastim and pegfilgrastim marketplace, and regarding improving access to biosimilars in general. Doug Long, IQVIA BR&R: Do you think interest by manufacturers in biosimilars is gaining or waning at this time? Doug Long: It’s … Continue reading A Conversation With Doug Long, IQVIA