Pfizer's (PFE) Avastin Biosimilar Zirabev Gets FDA Approval

Pfizer, Inc. (NYSE:PFE) announced that the FDA has granted approval to Zirabev, its biosimilar version of Roche’s (OTC:RHHBY) blockbuster cancer drug, Avastin for several types of cancer.

Zirabev can be prescribed for the treatment of five types of cancer — metastatic colorectal cancer, unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent glioblastoma, metastatic renal cell carcinoma and persistent, recurrent or metastatic cervical cancer.

This is Pfizer’s second oncology biosimilar to be approved in the United States, the first being a biosimilar of Roche’s breast cancer drug, Herceptin. Pfizer gained FDA approval for Trazimera, its biosimilar version of Herceptin in March this year.

Amgen/Allergan’s biosimilar version of Avastin, Mvasi was approved by the FDA in 2017 and in the EU in early 2018. However, Mvasi has not been launched yet. Several other companies like Samsung (KS:005930) Bioepis and Boehringer Ingelheim are also developing biosimilar versions of Avastin.

Pfizer’s shares have declined 0.8% this year so far against an increase of 2.2% for the industry.

At present, in the United States, Pfizer has six approved biosimilar products including Inflectra, its first biosimilar version of J&J/Merck’s Remicade, which was launched in November 2016. Pfizer also markets biosimilar versions of Amgen’s (NASDAQ:AMGN) drugs, Neupogen and Epogen in Europe and the United States.

Pfizer is gradually venturing into the oncology biosimilars space. A biosimilar version of Roche’s another cancer medicine, Rituxan is also under review and FDA’s decision on the same is expected this year. With a biosimilar version of AbbVie’s (NYSE:ABBV) Humira also under review in the United States, Pfizer expects potential U.S. approvals for up to four biosimilar products in 2019. Of these, the company has already received approval for Zirabev and Trazimera.

Biosimilar versions of Herceptin and Avastin are already approved in the EU while that of Rituxan is under review in the EU. Meanwhile, Pfizer is evaluating several biosimilar molecules in various stages of development.

In a separate press release, Pfizer announced that a phase III study evaluating its pulmonary arterial hypertension (PAH) drug, Revatio (sildenafil citrate) for another indication did not meet its primary efficacy endpoint. The study was evaluating intravenous sildenafil added to inhaled nitric oxide (iNO) for the treatment of newborns with persistent pulmonary hypertension (PPHN). Presently, Revatio is not approved for the treatment of PPHN. The data showed that treatment with sildenafil+iNO did not result in a statistically significant reduction in treatment failure rate or time on iNO versus iNO alone. Revatio is the trade name of sildenafil citrate in EU and Japan while in the United States, Pfizer markets it by the trade name of Viagra to treat erectile dysfunction and PAH.

Pfizer currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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