Another Biosimilar Approval From FDA, Another Unknown Launch Date

Regulatory NewsRegulatory News | 28 June 2019 |  By 

The US Food and Drug Administration (FDA) on Friday approved Pfizer’s Zirabev (bevacizumab-bvzr), the 21st biosimilar in the US and the second for Roche’s cancer treatment Avastin (bevacizumab).

But the launch date in the US for Zirabev, a treatment for five types of cancer, remains unknown, as does the launch date for its predecessor, Amgen’s Mvasi (bevacizumab-awwb), approved in September 2017. Similarly, two Enbrel (etanercept) biosimilars have been approved, the first of which came in August 2016 for Sandoz’s Erelzi (etanercept-szzs), and neither has lunched.

But Bernstein analyst Ronny Gal estimates that Roche’s three biologics: Avastin, Rituxan (rituximab) and Herceptin (trastuzumab), which cumulatively account for $10 billion in US sales, will see biosimilar competition between the second half of 2019 and the first half of 2020. In addition to the two bevacizumab biosimilars, there is one approved rituximab biosimilar. Five trastuzumab biosimilars have also been approved. 

Overall, just one-third of biosimilars approved by FDA have launched, and for many of them the date of launch has not been announced publicly. AbbVie’s Humira (adalimumab) is the exception, with biosimilar launch dates announced for between January and November 2023, which is 21 years after Humira was first approved.

As the biosimilar delays and commercialization games at the payer level continue, the Biosimilars Council this week published a white paper, “Failure to Launch,” which found that delayed US entry to biosimilars has cost $7.6 billion in savings since 2015. The paper calculated the savings for the approved biosimilars that currently remain off the market, assuming they had been marketed upon receiving FDA approval.

Biosimilar development has also been halted in some areas recently.

Amgen said Friday that it's withdrawing its biosimilar infliximab from review in the EU. Earlier this year, Pfizer and Momenta both dropped multiple biosimilar development programs and last year, Sandoz halted its submission for biosimilar rituximab in the US. Boehringer Ingelheim also said it was abandoning all biosimilar development work outside the US, and Oncobiologics announced it was changing its name to Outlook Therapeutics and is no longer pursuing its bevacizumab and adalimumab biosimilars.


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