Biosimilars, Consumer Advertising and Medical Device and In Vitro Diagnostic Regulations

November feature articles covered:

• An Update on Biosimilars
• Global IVD Regulation and Changing Clinical Evidence Requirements
• Consumer Advertising and Medical Device Regulations
• Regulatory Information Management
• Regulatory Science

Biosimilars and Regulatory Science

Over the last 10 years, biosimilar acceptance has progressed significantly in Europe and the US although several organizations are advocating for more complete, accurate, transparent prescribing and dispensing information. In “Regulatory Progress of Biosimilars: An Update,” global regulatory expert, Alok Bandyopadhyay, discusses issues related to the development and marketing of biosimilars aimed at having the same therapeutic effects as biotherapeutics and covers biosimilar approvals in Europe and the US, comparability studies, labeling issues, interchangeability and postmarketing issues.

Senior regulatory consultant, Shweta Menon, presents an overview of biosimilars and explains their benefits, similarities to “reference” biologics, clinical applications and recent regulatory challenges.

“What are biosimilars and why are they important?” is intended to provide a top-level introduction to regulatory professionals who have a limited awareness of or are new to biosimilars.

Regulatory science is the discipline of overseeing, creating and implementing innovation for global health needs. Regulatory scientist Jan Fourman continues her discussion in “Theoretical Perspective of Technology for Regulatory Science: Part 2” and emphasizes the need to adopt problem-solving tools or ‘global skills.’

Global  Medical Device and In Vitro Diagnostic Regulations

Millions of patients worldwide depend on broadening the array of medical devices for the diagnosis and management of their disease. In “A Comparative Study of US and EU Medical Device Regulations,” regulatory specialists Nikita Patel and Valerie Smith Beyer debate a frequent point of comparison for device regulation and compare the differences in US and EU regulatory approaches, costs and the length of time for medical device clearance or approval, marketing and postmarket surveillance requirements. The authors conclude that in both systems, there is a need for harmonization of medical device regulations in consideration of patient access and safety.

Whether a company is small or large, the idea of needing a clinical trial to demonstrate device performance can seem daunting. In “The Changing Clinical Evidence Requirements Under IVDR,” senior vice president Karen L. Richards and senior consultant Mona Dean discuss the key elements of clinical requirements per the In Vitro Diagnostic Regulation (IVDR) and clinical planning. The IVDR emphasizes the need for manufacturers to demonstrate the clinical evidence for all medical devices.

Regulatory legal experts Jeff Gibbs and Allyson Mullen summarize the regulatory history of Laboratory Developed Tests (LDTs) and describe where we are now and where we may be heading in “LDT Regulation: Past, Present and Future.”

Millions of healthcare professionals and patients around the world rely on in vitro diagnostic medical devices to provide accurate results and be safe to use. In a global economy, manufacturers want their products on the market in multiple regions as expeditiously as possible. Harmonization of regulations and regulatory practices can go a long way in ensuring that healthcare professionals, patients and manufacturer’s needs are met. In “Global IVD Regulations: Are they harmonized yet?” regulatory expert Jocelyn Jennings examines the In Vitro Diagnostic (IVD) Medical Device Regulations in multiple regions to provide an assessment of whether or not harmonization efforts have been fulfilled.

Regulatory advertising and promotion expert Peter Isikwe discusses the potential impact of an amendment to a US Senate healthcare spending bill that could require drug manufacturers to disclose their drug prices in all direct-to-consumer television advertisements. In “New Drug Price Transparency Requirements in Direct-to-Consumer Advertisements,” the author questions whether creating this kind of transparency will help lower drugs costs, as some claim it will, or if passed, confuse consumers and negatively impact the pharmaceutical industry and how regulatory professionals do their jobs.

An interview with two Eli Lilly regulatory professionals, Nancy Allen and Paula Hudson, explains how and why they took a “process-centric approach” to transforming their Regulatory Information Management (RIM) system. “Making Regulatory Information Management (RIM) Transformation Work” outlines Lilly’s three goals for implementing a global RIM transformation.

What’s coming in December?

Feature articles will cover a variety of topics, including

• Quality System Integration
• Regulation of Cybersecurity Networked Medical Devices
• Drug Facility Establishment Registration
• Integrated Pharmaceutical Supply Chain Security
• Regualtory Drivers for Serialization and Compliance
• Good Distribution Practices
• How to Perform a GMP Audit
• MDR: how did we get here?

More From Regulatory Focus

Mark your calendars for 12 December at 1.30 EST to participate in the latest Regulatory Exchange on advertising, promotion and labeling regulations and discuss the latest RF Article Series.

Ideas?

Send comments and recommend topics for a feature article or series to ghall@raps.org. I welcome your feedback.