The Top 5 Biosimilars Articles for the Week of July 6
Here are the top 5 biosimilars articles for the week of July 6, 2020.
Number 5: The next stop in a long-running court battle between Sandoz and Amgen over a biosimilar etanercept could be the Supreme Court of the United States, after a federal court upheld 2 patents held by Amgen for its originator drug Enbrel.
Number 4: After a study from India suggested a higher incidence of adverse reactions in patients using biosimilar filgrastims, 2 European biosimilar consultants and oncologists raised objections to the study’s methodology.
Number 3: Rituximab was originally approved for treatment of non-Hodgkin lymphoma and has multiple additional approvals for orphan and nonorphan indications. But a recent study found off-label uses now account for more than half of patients receiving rituximab.
Number 2: In upholding a lower court ruling, a federal circuit court has decided that Amgen gave enough notice prior to launching its bevacizumab biosimilar. The court decision has frustrated an attempt by Genentech to block sales of the product.
Number 1: A pair of bipartisan senators introduced S 4134, a bill that aims to lower health care costs and increase access to biosimilars by instructing CMS to develop a shared savings model for biosimilars.
To read all of these articles and more, visit centerforbiosimilars.com.
HHS Praises Biosimilars Savings but Opportunities to Reduce Part B Spending Remain
November 28th 2023Although biosimilars have already generated savings for Medicare Part B programs and beneficiaries, opportunities for substantial reductions in spending remain, according to a report from the HHS.
Phase 1 Study Finds Comparable PK, PD Parameters in Biosimilar GP40141 vs Reference Romiplostim
November 25th 2023A phase 1 analysis confirms that romiplostim biosimilar candidate GP40141 has comparable pharmacokinetic (PK) and pharmacodynamic (PD) parameters in healthy volunteers compared with the reference product.
Biosimilar Business Roundup for October 2023—Podcast Edition
November 5th 2023On this episode, we discuss the biggest news to come out of October 2023, including 3 regulatory approvals, 2 complete response letters, and new data and industry insights that have the potential to impact the entire US biosimilar industry.
Eye on Pharma: Adalimumab Updates; New Eylea Biosimilar Lawsuit; Canada Gains Stelara Biosimilar
November 22nd 2023Several companies make moves to further their adalimumab biosimilars, Regeneron sues Celltrion over biosimilar for Eylea (aflibercept), and Health Canada grants marketing authorization for biosimilar referencing Stelara (ustekinumab).
