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18/12/2018 09:56:48
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Pfizer Gains Positive CHMP Opinion for Bevacizumab Biosimilar, Withdraws "Skinny Label" Adalimumab Application

On Friday, Pfizer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of its proposed bevacizumab biosimilar, PF-06439535, to be marketed under the trade name Zirabev.

On Friday, Pfizer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of its proposed bevacizumab biosimilar, PF-06439535, to be marketed under the trade name Zirabev. For the potential biosimilar referencing Avastin, Pfizer is seeking indications for the treatment of carcinoma of the colon or rectum, breast cancer, non–small cell lung cancer (NSCLC), renal cell cancer, and cervical cancer.

In a statement announcing the positive opinion, Joe McClellan, vice president of biosimilars development at Pfizer, said, “If approved, Zirabev has the potential to expand access to this life-changing biologic cancer therapy for appropriate patients and healthcare professionals across Europe. Today’s positive CHMP opinion underscores Pfizer’s strong heritage in oncology and its ongoing commitment to bringing high-quality biosimilars to market, providing additional options for people living with certain cancers.”

The positive CHMP opinion was based on a data package that included results from the phase 3 REFLECTIONS B739-03 clinical comparative study that showed the clinical equivalence of Zirabev with the reference bevacizumab in patients with nonsquamous NSCLC. According to Pfizer, as part of the overall REFLECTIONS clinical program, the proposed biosimilar has been studied in approximately 400 individuals.

The next step for Pfizer will be to await the European Commission (EC)’s final decision on whether to grant a marketing approval for the biosimilar. If the EC ultimately approves the product, it will grant Pfizer a centralized marketing authorization that will be valid in all 28 EU member states. Norway, Iceland, and Liechtenstein, members of the European Economic Area, will follow corresponding decisions based on the EC’s decision.

During the same week that Pfizer announced its positive CHMP opinion for the bevacizumab product, the European Medicines Agency revealed that, on December 5, Pfizer gave official notice to the CHMP that it was withdrawing its application for an adalimumab biosimilar referencing Humira. The proposed biosimilar, Fyzoclad, had previously sought approval for the treatment of multiple inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, and uveitis, among others.

A representative from Pfizer told The Center for Biosimilars® in an email that the company had originally submitted 2 applications to the EMA: 1 that encompasses all indications of the reference adalimumab, and 1 that had a proposed label that reflected fewer than all of the approved indications of the reference Humira. “We withdrew the limited label application (known as Fyzoclad) and retained the full label application which is still currently under review,” said Pfizer’s email.

News of the withdrawal of the "skinny label" for adalimumab comes shortly on the heels of an announcement that Pfizer and AbbVie, maker of the reference Humira, had reached a global settlement resolving all property disputes related to the reference Humira’s patents. Under the terms of the settlement, Pfizer gained the right to launch the biosimilar in the European Union at the time of approval, and on November 20, 2023, in the United States.



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