At an earnings call this week, Pfizer’s CEO highlighted the
impending launches of Ruxience®
not long after the previously announced launch of Zirabev®
(bevacizumab) at the end of this year.
The New York–based pharmaceutical manufacturer plans to
begin marketing Ruxience in January 2020, and Trazimera February 15, 2020. This
would make Pfizer first to market with a Rituxan® competitor. Pfizer
follows Amgen to market with Trazimera, as Kanjinti®
launched in July this year.
On the call, Albert Bourla, PhD, indicated that the
company’s infliximab biosimilar (Inflectra®) had grown 8% for the
third quarter of 2019 over the same quarter in 2018 (to $77 million). Inflectra’s
marketshare in the US still remains below 10%, according to IQVIA.
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.
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
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, 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,
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
biosimilars) very shortly.