Tag: Mvasi

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 September 19. It clears all remaining patent suits filed by Genentech (and its parent Roche), and if it follows the standard terms of previous agreements, pays a license to the maker of the reference product (Avastin®).

Amgen decided to launch Mvasi at-risk, gaining the advantage of being the first bevacizumab biosimilar available for prescription. The legal case brought by Genentech against Amgen hinges less on patent infringement but more on whether 6-month notice of launch was provided (or needed). The next step in this case is reportedly a trial sometime in 2020.

At least five other bevacizumab biosimilars are actively being investigated, but none of these are likely to be approved in 2020 (none have filed 351[k] applications to date).

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 a restraining order against Amgen. For Amgen, this marks the first two biosimilars to reach commercialization.

The launch discounts associated with these two agents is only 15% off of average wholesale price (AWP), but the manufacturers point out that is still significantly below the average selling price (ASP) of the two reference drugs—13% lower than that for Herceptin® and 12% lower than that for Avastin®. This pricing does not include potential rebates or discounts that could further reduce the net costs of these biosimilars.

The launch timing raises the question of when the FDA-approved biosimilar competition will be launched. Other biosimilars in the trastuzumab space have signed licensing agreements with Genentech, the maker of Herceptin. Their launch dates have not been disclosed. Several biosimilar makers have also signed licensing agreements with Genentech on their versions of Avastin, and their launch dates may be upcoming as well.

Assuming the licensing agreements compel the other manufacturers to pay some percentage of sales or profits to Genentech, this could give Amgen/Allergan an automatic edge in profitability. It is unknown whether the launch timing of Mvasi and Kanjinti, have any implications for the existing licensing agreements. For example, it may be possible that an early launch by an unlicensed competitor could negate specific clauses of these contracts.

The bevacizumab biosimilar class progress had stagnated through court proceedings and licensing agreements. In a post from January 2019, we had noted that Amgen had notified the court that it was prepared to launch as early as April 2018.

On the trastuzumab side, Amgen/Allergan’s product was the most recently approved biosimilar (in June 2019).

In their joint press release, they quoted Paula Schneider, CEO of the Susan G. Komen Breast Cancer Foundation. “The introduction of biosimilars is an important step in increasing options for treating HER2-positive breast cancers, which account for about 25% of all breast cancers,” she said. “As patient advocates, we are working to ensure that patients are educated about biosimilars and understand that these FDA-approved treatments are just as effective as the original biologic drugs.”

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®.

Pfizer approval of Zirabev

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, metastatic, or recurrent nonsquamous non–small cell lung cancer
  • Metastatic colorectal cancer
  • Recurrent glioblastoma
  • Metastatic renal cell carcinoma
  • Metastatic cervical cancer

This approval does not include ovarian cancer, which is an additional indication for Avastin. Belonging to a class of biologics called vascular endothelial growth factor (VEGF) inhibitors, these agents work by preventing new development of a tumor’s blood vessels, helping to choke off growth.

Zirabev’s approval marks the 21st FDA approved biosimilar agent and the second approval for a bevacizumab biosimilar. Mvasi®, to be manufactured by the partnership of Amgen and Allergan, obtained approval in September 2017. However, this product is not yet marketed.

At a recent annual meeting of the Academy of Managed Care Pharmacy, a specialty drug pipeline expert expressed hope that Mvasi would be launched in July of this year. Its manufacturer has been embroiled in patent litigation with Roche, but the key patents are expected to expire in the immediate future.

Pfizer has not announced a launch date for Zirabev. Yet, it could be the second cancer-treating biosimilar category to enter competition (with Herceptin biosimilars) very shortly.

Amgen/Allergan Score Positive EMA Evaluation, but Launch Will Be Delayed

A couple of noteworthy pieces of news have emerged from across the pond on the biosimilar front. The first involves progress for Amgen’s application for its bevacizumab biosimilar at the European Medicines Agency (EMA). Its drug evaluation arm, the Committee for Medicinal Products for Human Use, recommended approval of the biosimilar on November 9.

Assuming EMA final approval is received, however, Amgen and Allergan’s cancer treatment agent will not be marketed any time soon. The principal European patent is not set to expire until 2022.

Image result for avastin biosimilarIn the US, Mvasi™ was approved by the Food and Drug Administration in September, but its launch is similarly delayed by patent litigation. The main US patents should expire in 2019 (Roche claims to hold 27 enforceable patents). Amgen had filed suit October 6 challenging the validity of the patents in question, but this case may not be heard until late 2018. Amgen has the option of launching “at-risk,” but it has not indicated that it will go this route. Otherwise, the earliest launch may be sometime in 2019.

Several other potential bevacizumab makers have already challenged the patents, according to other reports. These include Boehringer Ingelheim, Celltrion, Pfizer, and Samsung Bioepis.

In other related news…An announcement will be made on November 20 regarding where the EMA will relocate its headquarters as a result of the Brexit. The Agency will need to complete its move by March 31, 2019, when Britain’s divorce from the European Union is finalized.

Amgen Receives Approval for Bevacizumab Biosimilar

The Food and Drug Administration announced today the approval of the first biosimilar for Roche’s Avastin®. The approval of Mvasi™ (bevacizumab-awwb) represents the first biosimilar approved in the US for the direct treatment of cancer. Amgen is partnered with Allergan in the development and marketing of the new biosimilar.

Its approved indications include:

  • Metastatic colorectal cancer, in combination with intravenous 5-fluorouracil-based chemotherapy for first- or second-line treatment. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
  • Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy for the second-line treatment of patients who have progressed on a first-line bevacizumab product-containing regimen. Mvasi is not indicated for the adjuvant treatment of surgically resected colorectal cancer.
  • Non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first line treatment of unresectable, locally advanced, recurrent or metastatic disease.
  • Glioblastoma with progressive disease following prior therapy, based on improvement in objective response rate. No data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab products.
  • Metastatic renal cell carcinoma, in combination with interferon alfa.
  • Cervical cancer that is persistent, recurrent, or metastatic, in combination with paclitaxel and cisplatin or paclitaxel and topotecan.

Like Avastin, Mvasi will carry a black box warning involving gastrointestinal perforations, surgery and wound healing problems, and severe or fatal hemorrhage.

The FDA’s Oncology Advisory Committee had unanimously recommended approval of the agent. No announcement was made by Amgen as to pricing or availability of the new product.