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.
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.
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.
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.
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.
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.
Eye on Pharma: Keytruda Biosimilar Deal; German Court Bans Imraldi; New Biosimilars for Japan
June 17th 2025Alvotech and Dr. Reddy's partner to develop a Keytruda biosimilar, a German court bans Humira biosimilar over patent dispute, and Samsung Bioepis enters a strategic agreement with NIPRO Corporation in Japan.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Switching From Avastin to Bevacizumab-bvzr in CRC, NSCLC Can Reduce Medicare Costs
May 10th 2025Monthly savings from fully converting Medicare patients with metastatic colorectal cancer (CRC) and non-squamous metastatic non-small cell lung cancer (NSCLC) from reference bevacizumab to bevacizumab-bvzr could fund 13,887 and 8,959 additional patient-months of treatment, respectively, according to a cost-effectiveness study.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Samsung Bioepis Report Signals Turning Point for US Biosimilars
May 1st 2025A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the US biologics market, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.