At an earnings call this week, Pfizer’s CEO highlighted the impending launches of Ruxience® and Trazimera®, not long after the previously announced launch of Zirabev® (bevacizumab) at the end of this year. The New York–based pharmaceutical manufacturer plans to begin marketing Ruxience in January 2020, and Trazimera February 15, 2020. This would make Pfizer first … Continue reading Pfizer Announces Launch Dates for Rituximab and Trastuzumab Biosimilars
Tag: Herceptin
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
Pfizer Receives Approval for Trazimera, the Fourth Trastuzumab Biosimilar
A fourth trastuzumab biosimilar has been approved by the US Food and Drug Administration (FDA). Pfizer's biosimilar version of trastuzumab-qyyp (Trazimera) gained approval on March 11. The principal phase 3 study tested Trazimera against the EU-licensed version of Herceptin®. The REFLECTIONS B327-02 study found no relevant differences in the clinical and safety outcomes for patients with … Continue reading Pfizer Receives Approval for Trazimera, the Fourth Trastuzumab Biosimilar
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?
FDA Approval Eludes Amgen for Biosimilar Trastuzumab
Amgen will have to wait a bit longer to market its biosimilar version of trastuzumab . On Friday, June 1, the Food and Drug Administration (FDA) rejected Amgen’s 351(k) application for its Herceptin® biosimilar. In a brief press release, Amgen announced receiving the complete response letter for ABP 980. In the announcement, it also said that the … Continue reading FDA Approval Eludes Amgen for Biosimilar Trastuzumab
Celltrion Bounces Back, Resubmits for FDA Approval of Rituximab Biosimilar
Anticipating that its issues with the Incheon, South Korea, manufacturing plant will be resolved, Celltrion has resubmitted its biologic license application for a rituximab biosimilar (CT-P10). In the April 2018 complete response letters sent by the Food and Drug Administration (FDA) on CT-P10 and the trastuzumab biosimilar CT-P6, FDA cited aseptic practices at the manufacturing … Continue reading Celltrion Bounces Back, Resubmits for FDA Approval of Rituximab Biosimilar