Here are the top 5 biosimilar articles for the week of May 10, 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 May 10, 2021.
Number 5: During a talk at the Medicines for Europe Biosimilar Medicines Conference, US and EU regulators discuss the potential for a tailored approach to bring biosimilars to market sooner with less expense and wasted effort.
Number 4: Pfizer doubles down on its pledge to fight rebates, and Organon executives discuss the growth potential of the planned Merck spinoff.
Number 3: Fighting back against a suit that alleges theft of trade secrets, Alvotech has filed suit against AbbVie alleging that key patents for its blockbuster adalimumab drug (Humira) should be invalidated partly on grounds that AbbVie did not invent the processes that were patented.
Number 2: This year marks the 15th anniversary of biosimilar availability in the European Union, and in an overview sponsored by Medicines for Europe, experts from regulatory and business venues discussed some of the major achievements and hurdles yet to be crossed.
Number 1: A deep dive into the anatomy of a biosimilar switching study reveals what it takes for a biosimilar to be approved as interchangeable in the United States.
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.
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.
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.