Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Non-binding Guidance: FDA Regulatory and Patent Implications of the Transition Provision of the Biologics Price Competition and Innovation Act
Drug Pricing Initiatives During the Trump Presidency
A changing competitive landscape: the role of the ITC in the biosimilars space
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
Rituximab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
FDA grants interchangeable designation to Pfizer’s adaliumumab biosimilar – On October 5, 2023, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an...more
On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen. The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2017...more
Marketing approval for US biosimilars has taken off in 2017. FDA has approved five biosimilar products this year, increasing the number of approved biosimilars from four to nine. In addition to new biosimilars of AbbVie’s...more
Below are recent updates in biosimilar-related IPR proceedings: GENERAL BIOLOGICS PATENTS - On December 1, 2017, the Board granted institution of four IPRs on Celltrion’s petitions (IPR2017-01373 and IPR2017-01374) and...more
Here are our picks for the top-five most significant U.S. market developments in the world of biosimilars in 2016: The FDA approved three biosimilar products in 2016, compared to only one in 2015 — Sandoz’s Zarxio®, a...more