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: Roche
The Biosimilar Mabs Have It: FDA Approves Biosimilars for Adalimumab and Rituxumab
In a busy beginning of the week, the US Food and Drug Administration approved new biosimilars for Humira®and Rituxan®. Samsung Bioepis gained approval for Hadlima™ (adalimumab-bwwd), and Pfizer scored with Ruxience™ (rituximab-pvvr). HADLIMA The approval for Hadlima covers the following indications: Rheumatoid arthritisJuvenile idiopathic arthritisPsoriatic arthritisAnkylosing spondylitisCrohn’s disease in adultsUlcerative colitisPlaque psoriasis Formerly known as SB5, … Continue reading The Biosimilar Mabs Have It: FDA Approves Biosimilars for Adalimumab and Rituxumab
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
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
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
Samsung Bioepis Scores FDA Approval of Ontruzant, the Third Biosimilar Trastuzumab
The US Food and Drug Administration (FDA) announced on January 18, 2019 the approval of a new biosimilar version of trastuzumab. Produced by Samsung Bioepis, this agent was dubbed Ontruzant (trastuzumab-dttb). This is the third trastuzumab biosimilar approved by the FDA, following those by Mylan and Biocon in December 2017 (Ogivri®) and Teva and Celltrion … Continue reading Samsung Bioepis Scores FDA Approval of Ontruzant, the Third Biosimilar Trastuzumab
Will the Government Shutdown Slow Biosimilar Approvals?
The partial federal government shutdown is having specific effects in various important areas of government, but it may not be particularly troubling for FDA user-fee funded activities. Scott Gottlieb, MD, Commissioner of the FDA, has been especially busy on Twitter, trying to inform the public how the government shut down is affecting FDA operations. He … Continue reading Will the Government Shutdown Slow Biosimilar Approvals?
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