Pfizer's trastuzumab and rituximab biosimilars have seen dramatic average sales price reductions, reaching up to 93% lower than competitors. Trazimera and Ruxience pricing dropped significantly, despite maintaining notable market shares in their categories. Additionally, Xbrane Biopharma received FDA approval for its ranibizumab biosimilar, Lucamzi, enhancing market competition.
Tag: Pfizer
Pfizer Reaches Milestone: FDA Approves 25th Biosimilar in US
Pfizer announced November 18th that the biosimilar licensing application (BLA) for its adalimumab biosimilar was approved by the Food and Drug Administration (FDA). The drug will be marketed under the name Abrilada™ (adalimumab-afzb) in November 2023, according to the terms of a licensing agreement with AbbVie. According to Pfizer, the drug was approved for … Continue reading Pfizer Reaches Milestone: FDA Approves 25th Biosimilar in US
Partners Teva/Celltrion Seek the Jump on Pfizer, Launch Their Rituximab Biosimilar Next Week
When Pfizer announced its intention just more than a week ago to begin marketing its rituximab biosimilar Ruxience® in January 2020, industry watchers wondered when we might hear a response from its sole approved competitor. The wait was over quickly: Teva and Celltrion will begin shipping their own rituximab biosimilar Truxima® on November 11. Truxima … Continue reading Partners Teva/Celltrion Seek the Jump on Pfizer, Launch Their Rituximab Biosimilar Next Week
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
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
Even Today, Patients and Payers Hold the Key to Biosimilar Uptake Success
Reading the white paper co-published March 19 by the US-based Biosimilars Forum and UK-based Medicines for Europe highlighted for me the importance of an essential roadblock to increased biosimilar uptake in the US. The white paper outlined structural market changes needed in the US to gain comparable conversion of marketshare in the European market. Without … Continue reading Even Today, Patients and Payers Hold the Key to Biosimilar Uptake Success
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
A Profile of a Lesser-Known Player in the Biosimilar Space: Bio-Thera Solutions
On occasion, we profile some biosimilar manufacturers about whom our readers may not be familiar. 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 post, we highlight a Guangzhou, China–based company, Bio-Thera Solutions. Established … Continue reading A Profile of a Lesser-Known Player in the Biosimilar Space: Bio-Thera Solutions
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?