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
In the last month, the FDA has granted interchangeability status to additional adalimumab biosimilars. Biosimilars with an interchangeable designation may be substituted for the reference product at the pharmacy without...more
Join our 2024 Mid Year Pharmacy Benefits Update webinar for a comprehensive analysis of the current pharmacy landscape. This informative session will delve into key trends, including the evolving biosimilars market, the...more
2022 Medicaid Drug Rebate Program Summit Concludes: The annual Medicaid Drug Rebate Program Summit took place Oct. 12-14 in Chicago. Latham partner Christopher H. Schott spoke at two sessions: the panel “Ask the Attorneys:...more
New challenges may lie ahead for the pharmaceutical industry - What’s next for drug pricing in the US? Proposals to alter antitrust and patent laws may signal a renewed focus on drug pricing by federal lawmakers,...more
This month, a working group within the Pharmacy Directors Forum of the National Comprehensive Cancer Network (NCCN) has reviewed and highlighted “some of the potential challenges regarding adopting biosimilars into clinical...more
Food - FDA Released Retail Food Employee Health Handbook – The FDA published the Employee Health and Personal Hygiene Handbook to help food employees avoid spreading viruses and bacteria to food....more
In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more
Walgreens and Kroger have filed an antitrust action in the United States District Court for the Eastern District of Pennsylvania accusing Johnson & Johnson (J&J) of engaging in anticompetitive conduct designed to stymie the...more
Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more
Last week, both Wisconsin and West Virginia passed legislation intended to facilitate the dispensing and substitution of biosimilar products. Wisconsin and West Virginia join Michigan, which enacted House Bill 4472 on...more
South Dakota passed a law that allows pharmacists to automatically substitute a biosimilar for a prescribed biological product. According to the new law, which was signed by South Dakota’s governor on February 12, 2018, the...more
More states continue to enact laws regarding the substitution of biosimilars for prescribed biological products. We have previously reported on the enactment of such laws in New Jersey, Arizona, Missouri, Oregon and...more
In August 2016, we reported that CVS dropped Neupogen® (filgrastim) and Lantus® (insulin glargine) from its standard formulary and replaced them with biosimilar versions. Hikes in insulin drug prices have prompted pharmacies...more
With 2015 coming to a close, we wanted to provide a recap of the major updates impacting the pharmacy industry and what pharmaceutical manufacturers, pharmacy benefit managers (“PBMs”), and pharmacies might expect in 2016. ...more
This Week: Bipartisan Senate Letter Questions HHS and CMS on Details of State ACA Waivers...OMB Is Reviewing Final Medicaid-Covered Outpatient Drug Rule...Delaware Forgoes Transition to State-Based Exchange....more
On March 25, Indiana Governor Mike Pence signed legislation (Senate Bill 262) that will allow pharmacists in Indiana to substitute an interchangeable biosimilar product for a prescribed biological product if certain...more
Last week, Governor Jerry Brown vetoed a California bill (SB-598) that would have authorized a pharmacist to select a biosimilar when filling a prescription order for a prescribed biological product, provided that the...more