Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
With the recent convocation of the 119th Congress, a change in administration, and resignation of USPTO Director Vidal, pharmaceutical patent reform is likely on the minds of many in Washington. Prior to this political...more
Recent history of Congress's performance as a legislative body has been, to be kind, mixed, and a great many bills, resolutions, and other activities have appeared to be more for show than to accomplish anything worthwhile. ...more
Recently the Senate passed S.150 entitled the Affordable Prescriptions for Patients Act. Those paying attention might recall that Senator Cornyn (R-TX) introduced this bill (joined by Senator Blumenthal (D-CT) and seven other...more
2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more
2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more
On Monday, March 6, House Republicans unveiled their plan to repeal and replace the Affordable Care Act (“ACA”). Although the proposed legislation repeals or amends several provisions of the ACA, based on a preliminary...more
While Donald Trump’s victory has made world headlines, what may be less well known to our readers is that the election also gave Trump’s Republican Party majority control of both the House and the Senate. For the first time...more