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
Tag: Genentech
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
Samsung Bioepis Signals a Settlement With Genentech on Herceptin Biosimilar
And then there was one. Samsung Bioepis and Genentech filed a motion in District Court to drop all pending patent litigation regarding Ontruzant®, an approved Herceptin® biosimilar. A Joint Stipulation of Dismissal is usually the confirmation that a licensing agreement has been reached. This leaves one remaining approved trastuzumab biosimilar maker that has not settled … Continue reading Samsung Bioepis Signals a Settlement With Genentech on Herceptin Biosimilar
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
FDA Approves Celltrion and Teva’s Herceptin® Biosimilar
On December 14, the US Food and Drug Administration gave its approval for a new trastuzumab biosimilar (Herzuma™). Manufactured by Celltrion and marketed in the US by Teva, this agent has been designated trastuzumab-pkrb. The decision marks the second trastuzumab biosimilar approval, and the 16th biosimilar agentthat has made it through the 351(k) regulatory pathway. … Continue reading FDA Approves Celltrion and Teva’s Herceptin® Biosimilar
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
An FDA Filing for Momenta’s Adalimumab Biosimilar Coming Soon?
Momenta seems to be in final preparations for its first 351(k) filing to the Food and Drug Administration (FDA). In its recent investor conference, the company disclosed that it is ready to send M923, its adalimumab biosimilar, to the agency for approval. Despite this promising news, Momenta is facing strong headwinds. Even if it gains … Continue reading An FDA Filing for Momenta’s Adalimumab Biosimilar Coming Soon?