Amgen Wins First EU Avastin Biosimilar Approval, But When Will It Launch?
Executive Summary
Partners Amgen and Allergan have become the first biosimilar developers to win EU approval for a copycat version of Roche's Avastin; commercialization preparation is underway but predicting a launch date for the product is more complicated.
Amgen Inc.'s Mvasi has won approval in Europe as the first biosimilar of Roche's best-selling cancer therapy Avastin (bevacizumab). This is the second time Amgen has been the first to gain approval of a critical biologic copycat product – but what are the benefits of being the early bird if you can't launch for several more years?
Following on from the EU approval of its Humira (adalimumab; AbbVie Inc.) biosimilar, Amgevita, in March 2017, Amgen has secured a regulatory nod for Mvasi for the treatment of certain cancers, including combination indications.
Mvasi, which was developed under a 2011 partnership with Allergan PLC, has already been approved in the US, having won FDA approval in September 2017. It was the first anticancer biosimilar to be authorized by the regulatory agency.
However, Amgen is unlikely to launch Mvasi in Europe until patents protecting Roche's originator product expire around January 2022. The product will come to market earlier in the US, where key Avastin patents are due to expire in July 2019.
Unlike innovative drugs, getting a regulatory approval before other competitors for a biosimilar does not appear to have immediate benefits when there are still legal hurdles preventing the copycat product entering the market. By the time Mvasi launches in Europe, if this event occurs after Avastin's patent protection runs out in 2022, there will be many biosimilar bevacizumab products waiting in the wings.
According to Biomedtracker, there are around 20 biosimilar bevacizumab products already in development. Mvasi is likely to launch in a very competitive market where it will have to compete against Avastin – as a recognizable, blockbuster brand – and other cheaper biosimilar options.
But, as the first to win over US and EU regulators, Amgen will enjoy some benefits. It has time to build relationships with prescribers, payers and procurement bodies, and work out how it can best add value through any additional services in the future – additions that may help the company secure a better price for the drug.
Amgen is also in a better position to negotiate with Roche, the originator company. With an approved biosimilar option in its portfolio, Amgen has a strong hand and is no longer just a theoretical threat to one of Roche's best-selling franchises. Amgen has the ability to launch at any time with its cheaper option (although doing so before 2022 would be at the risk of Roche launching patent infringement proceedings).
Roche's Avastin, an anti-VEGF (vascular endothelial growth factor) monoclonal antibody, brought in sales of around $3bn in 2016 and is one of Roche's best-selling franchises. However, the Swiss big pharma told Scrip it is confident of compensating for the impact of biosimilars with new medicines that it has recently launched or will launch soon. "Since 2013, we have received 18 FDA breakthrough designations, more than any other pharmaceutical company," a spokesperson noted.
Commercialization Strategy
Under its collaboration with Allergan, Amgen is primarily responsibility for developing, manufacturing and commercializing the oncology biosimilar products. Amgen has a total of 10 biosimilars in its portfolio, two of which have been approved by the European Commission: Amgevita and now Mvasi. Additionally, in 2017, Amgen and Allergan submitted marketing applications to both the EMA and FDA for ABP 980, a biosimilar candidate to Herceptin (trastuzumab; Roche). None of its biosimilar products are on the market yet, but Amgen expects Amgevita to launch in Europe in October 2018 and in the US in January 2023.
Amgen told Scrip it was "leveraging our nearly four decades of biotechnology experience and using the same personnel, services and manufacturing expertise from the company’s innovative business to produce high-quality, reliably supplied biosimilars for some of the most complex diseases."
However, the company would not provide any launch details for recently approved Mvasi.
Datamonitor Healthcare lead analyst Tijana Ignjatovic told Scrip that Amgen was likely to target Germany, the UK and Scandinavian countries first when it comes to launching Mvasi in Europe. She said these regions "have highest uptake potential and are markets where payers have the most power." Furthermore, the governments and healthcare systems in these countries are already sold on the value of biosimilars and have so far implemented aggressive measures to drive uptake.
In this particular case, Ignjatovic expects Amgen to target Germany before the UK because of limitations on Avastin's reimbursement in the latter region. "The drug is not routinely commissioned in the NHS in any cancer indication and only has funding through the UK's Cancer Drugs Fund for some patients," she noted.
Because of this, the situation in the UK is uncertain for an Avastin biosimilar. "Payers we have spoken to are not entirely sure what will happen next, whether the manufacturer or NHS England will need to request a new NICE assessment of the cheaper bevacizumab, there are no precedents for this situation," Ignjatovic said.
A spokesperson for Amgen said: "We look forward to providing Mvasi as an important treatment option for all the indications it was approved [in]."
Mvasi is approved for use in combination with fluoropyrimidine-based chemotherapy for metastatic carcinoma of the colon or rectum; in combination with paclitaxel for metastatic breast cancer; in combination with platinum-based chemotherapy for unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC); in combination with erlotinib for unresectable advanced, metastatic or recurrent non-squamous NSCLC; in combination with interferon alfa-2a for advanced and/or metastatic renal cell cancer; in combination with carboplatin and paclitaxel, carboplatin and gemcitabine, and paclitaxel, topotecan, or pegylated liposomal doxorubicin for advanced, platinum-sensitive, or platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer; and in combination with paclitaxel and cisplatin, or alternatively, paclitaxel and topotecan for persistent, recurrent, or metastatic carcinoma of the cervix.
While the drug is approved for use in these multiple cancer types, Ignjatovic expects colorectal cancer to be a key focus for Amgen when introducing the biosimilar to physicians. This starting point is likely to be driven by sales Avastin has achieved and the relative patient population size; colorectal cancer is the biggest patient group for the drug. From a payer perspective, though, "they will want to ensure the savings are maximized across indications," Ignjatovic said.
Amgevita will be the first test for Amgen's biosimilar commercialization strategy when it enters the EU market in October this year. This launch will shed more light on Amgen's ability and preparedness to market biosimilars as well as innovative pharmaceuticals and pave the way for Mvasi's launch – when the time comes.
Editor’s note: Thank you for reading this article. Please help us to better help you by taking our Pharma Feedback survey. Not only will your participation help steer our efforts to continually improve the content and delivery of our products – you’ll also have a chance to win one of four Amazon gift cards valued at $100 (US).