Recently, the Prescription Medicines Code of Practice Authority announced in a press release that 5 pharmaceutical companies have breached the Association of the British Pharmaceutical Industry’s Code of Practice.
Recently, the Prescription Medicines Code of Practice Authority (PMCPA) announced in a press release that 5 pharmaceutical companies have breached the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice. The code reflects and extends beyond UK law, and is administered by the PMCPA as part of a self-regulatory system that covers prescription medicines.
PMCPA publicly reprimanded Sunovion Pharmaceuticals Europe LTD for allowing 1 of its managers to encourage staff to suggest to customers that they could face legal action if they did not consider lurasidone (Latuda) as part of a patient review. It was ruled that Sunovion was in breach for failing to maintain a high standard of ethical conduct in the field, and for providing verbal direction that advocated a course of action that would lead to a breach of the Code. The public reprimand appears on the front cover of the PMCPA November 2017 Code of Practice Review. Subsequently, the Code of Practice Appeal Board also required Sunovion to be audited.
Additionally, all of the following companies were cited for, among other issues, bringing discredit to and reducing confidence in the pharmaceutical industry:
The full case reports are published in the PMCPA November 2017 Code of Practice Review, and are also available at www.pmcpa.org.uk.
FDA and Industry Experts Unpack Biosimilar Device Requirements
October 23rd 2024At the GRx+Biosims 2024 conference, a panel of industry experts and FDA officials discussed evolving device requirements for biosimilars and interchangeable biosimilars, highlighting new approaches to comparative use human factors studies, regulatory challenges, and alternative validation methods.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Eye on Pharma: Aflibercept Legal Drama; PBM, Humira Biosimilars; Denosumab Regulatory Review
October 15th 2024Regeneron appeals legal decision after judge refuses to block an aflibercept biosimilar; Prime Therapeutics, a pharmacy benefit manager (PBM), becomes the latest to offer biosimilars referencing Humira (adalimumab) at a low cost; the FDA and European Medicines Agency accept a denosumab biosimilar candidate for review.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Sandoz Report: A Unified Approach to Overcoming Drug Shortages
October 10th 2024A report from Sandoz emphasizes the need for collaboration among stakeholders to eliminate drug shortages impacting over 90% of hospital systems in the US, recommending policy changes and actions to address the ongoing issue, which has caused treatment delays and increased costs.