The Top 5 Oncology Articles of 2022

The top 5 most-read articles about oncology within the biosimilars industry involved a number of FDA approvals and new data on the market impact of biosimilar competition on Roche’s blockbuster reference products.

5. Despite Overall Increases, Blockbuster Roche Products Take Hit From Biosimilars

Roche’s first quarter of 2022 earnings showed significant decreases in revenue as a result of biosimilar competition in the trastuzumab, bevacizumab, and rituximab spaces. Despite the overall increase in revenue, the company experienced between 19% and 32% revenue decreases for Avastin (reference bevacizumab), Rituxan (reference rituximab), and Herceptin (reference trastuzumab), 3 reference products that compete against biosimilars in the marketplace.

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4. FDA Approves Fifth Pegfilgrastim Biosimilar, Fylnetra

The FDA approved Fylnetra, the fifth biosimilar referencing Neulasta (pegfilgrastim) to received regulatory approval in the United States. The biosimilar was the third biosimilars to be approved in 2022 and will be used to treat and prevent febrile neutropenia in patients with cancer undergoing chemotherapy. Fylnetra was developed by Amneal Pharmaceuticals and Kashiv Biosciences.

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3. FDA Approves Stimufend, the US’ Sixth Pegfilgrastim Biosimilar

Stimufend was approved by the FDA as the sixth pegfilgrastim biosimilar in the United States. The drug was developed by Fresenius Kabi and represented the second pegfilgrastim biosimilar, the fourth oncology biosimilar, and fifth biosimilar overall to be approved in 2022 for US marketing. Stimufend was also the first biosimilar from Fresenius Kabi to receive FDA approval and the company said that it anticipates to launch the product in early 2023.

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2. FDA Approves Amneal Pharmaceuticals’ Avastin Biosimilar, Bevacizumab-maly

Prior to the approval of Fylnetra, Amneal Pharmaceuticals’ Alymsys, a bevacizumab biosimilar, received the green light for marketing from the FDA. Alymsys was the third bevacizumab biosimilar to be approved in the United States. The biosimilar was developed by mAbxience but Amneal holds the US commercialization rights. Alymsys will be used to treat colorectal cancer, non-small cell lung cancer, recurrent glioblastoma, renal cell carcinoma, cervical cancer, among others.

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1. Teva Announces US Launch of Lenalidomide, Generic of Revlimid

Teva Pharmaceuticals shared the news that its generic of Revlimid (lenalidomide) was approved by the FDA to be administered in 5 mg, 10 mg, 15 mg, and 25 mg doses. It is the first lenalidomide generic to receive US approval. Lenalidomide is used in conjunction with other therapies to treat multiple myeloma, mantle cell lymphoma, and certain myelodysplastic syndromes. IQVIA data showed that annual sales of the Bristol Myers Squibb’s Revlimid amounted to $2.3 billion. Although Teva’s generic is the first in the United States, it likely will not be the last, as other companies in Europe have announced plans for their own lenalidomide generic drugs.

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