Amgen, Allergan win first approval of cancer biosimilar in US
- The Food and Drug Administration on Thursday approved Amgen Inc. and Allergan plc's biosimilar version of Swiss pharma Roche AG's blockbuster medicine Avastin, marking the first time the agency has approved a copycat biologic of a cancer drug.
- Amgen's biosimilar, which will be marketed under the brand name Mvasi, is cleared for use across five of Avastin's approved indications. Notably, however, it was not approved as an interchangeable, meaning pharmacists can't automatically switch patients taking Avastin to Mvasi.
- The approval highlights the growing competitive risk to Roche's trio of top-selling biologics: Herceptin, Avastin and Rituxan. A biosimilar of Rituxan made by the pharma's Swiss rival Novartis AG recently won EU approval, while a copy of Herceptin secured the backing of the European Medicines Agency just this week.
While biosimilar copies of Roche's top-selling medicines pose a competitive threat, it's not something that has taken the pharma giant unawares.
Roche believes it can sufficiently protect each franchise in the near-term as revenues from newer drugs grow enough to offset any eventual hits to its bottom line.
For Avastin (bevacizumab) specifically, growth from the company's immunotherapy flagship Tecentriq (atezolizumab) could cushion any declines Roche experiences due to biosimilar competition.
"I think the Avastin franchise in general will be supported by the entire immunotherapy program," said Daniel O'Day, head of Roche Pharmaceuticals, on a April 27 call with investors. "Tecentriq is being studied in many of the same indications to Avastin is in today, with and without Avastin."
Chief among those studies is the closely watched Impower-150 trial, which is comparing Tecentriq with chemotherapy and Avastin to just Tecentriq plus chemo in first-line treatment of non-squamous non-small cell lung cancer. Success there could help buoy both medicines, and data is expected later this year.
While Roche may have a plan for biosimilars, setbacks could mean sales erosion happens faster than anticipated. A study of the follow-on breast cancer drug Perjeta (pertuzumab), for example, delivered less positive than expected results, posing a challenge to Roche's aim of pairing the drug with Herceptin (trastuzumab) in an effort to protect its HER2 franchise.
And competition to all three of Roche's top biologics is set to grow further, as more companies hope to elbow into the lucrative markets. Mylan NV and Biocon Ltd.'s biosimilar version of Herceptin is currently under review by the FDA, although a decision has been delayed by three months. Others are either under review or set to be filed in the near term.
A statement on Mvasi's approval from FDA Commissioner Scott Gottlieb, who has emphasized the need to speed competition to market since taking office, suggested approving more biosimilars remains high on the agenda for the agency.
"We’ll continue to work hard to ensure that biosimilar medications are brought to the market quickly, through a process that makes certain that these new medicines meet the FDA's rigorous gold standard for safety and effectiveness," he said.
- Amgen, Inc. Press release
- Food and Drug Administration Press release
- BioPharma Dive Amid sales growth, Roche plans defense from biosimilar threats
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