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
President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more
The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents...more
The Cozen Lens - While it’s becoming ever clearer Vice President Harris is likely to be the Democratic nominee following President Biden’s decision to step aside, it’s less clear what the impact will be on the presidential...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
On November 17, 2022, Senator Mike Lee (R-UT) introduced the “Biosimilar Red Tape Elimination Act” to increase biosimilar competition and reduce patient costs by prohibiting the FDA from requiring switching studies to approve...more
Henrik Ibsen's 1882 play, An Enemy of the People, engendered an aphorism having a longer lifetime than the play itself (except amongst the literati) which is unfortunate, because the play has some lessons about human nature...more
As we close out another calendar year, we look back at the top legal developments of 2021 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district...more
On July 13, 2021, the Senate Judiciary Committee’s antitrust panel met to discuss biologic and biosimilar competition and its impact on drug prices. A group of senators, led by Senator Amy Klobuchar, are sponsors of a Senate...more
On July 1, 2021, twenty-eight patient advocacy groups submitted a letter demonstrating their support for the BIOSIM Act (H.R. 2815). The legislation was introduced on April 22, 2021 with the purpose of increasing Medicare...more
On April 23, 2021, Congressmen Schrader and Kinzinger introduced H.R. 2815, the Bolstering Innovative Option to Save Immediately on Medicines Act (“BIOSIM Act”). The bill provides for temporary increased reimbursement to...more
Last Wednesday, State Senator Carla Nelson and State Representative Jennifer Schulz of Minnesota announced the introduction of a bill aimed at reducing the price of certain medications by expanding access to biosimilars. The...more
After a committee hearing on the price of rheumatoid arthritis drugs last week, Senator Susan Collins (R-ME) announced that she is working on a bill designed to lower drug costs. According to Bloomberg Law, the aim of the...more
Just as the public comment period for the bicameral, bipartisan discussion draft of the “FDA Reauthorization Act of 2017” ended on Friday, what we have been calling the User Fee Games got even more interesting and engaging....more
Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more
Back in March, 2016, the Senate added language to the FDA and NIH Workforce Authorities Modernization Act which would exempt biological products, including biosimilars, from provisions of the FDCA Act that require compliance...more