The Top 5 Biosimilar Articles for the Week of September 20

Here are the top 5 biosimilar articles for the week of September 20, 2021.

Hi, I’m Skylar Jeremias for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.

Here are the top 5 biosimilar articles for the week of September 20, 2021.

Number 5: Investigators in China reported positive equivalence findings from a phase 3 trial of a bevacizumab biosimilar candidate (MIL60) and platinum-based chemotherapy as first-line treatment in Chinese patients with recurrent or advanced non–small cell lung cancer (NSCLC).

Number 4: A phase 3 study of a trastuzumab biosimilar candidate and the reference product (Herceptin) has demonstrated equivalence in patients with human epidermal growth factor receptor 2 (HER2)-positive early stage breast cancer, according to findings presented at the European Society for Medical Oncology (ESMO) Congress 2021.

Number 3: Alvotech gained an EU marketing recommendation for AVT02, a proposed adalimumab biosimilar; New Zealand may give preferential status to Amgen's adalimumab biosimilar; and BioFactura looks to deliver ustekinumab via a robotic pill.

Number 2: Alvotech said the FDA review of its high concentration, citrate-free adalimumab biosimilar candidate (AVT02) is held up by pandemic-related curbs on overseas inspections.

Number 1: The FDA has approved the first ranibizumab biosimilar (Byooviz, SB11) for multiple ophthalmologic conditions, although market launch is at least 9 months away, owing to patent protections on the originator product.

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