Biosimilar Regulatory solution center
Risk-Based Strategies For Revalidating Bio/Pharma Equipment & Systems
While equipment and systems validation is a regulatory requirement, it would take thousands of annual tests to retest all equipment and systems. BioPhorum shares risk-based approaches to new product introduction, controlled temperature chambers, sterilization processes, and more.
FDA Issues Pandemic Remote Inspection Guidance For Drug Manufacturing Facilities
On April 14, 2021, the FDA released a new guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. This article discusses planning, conducting, and concluding a remote interactive evaluation under this guidance, and shares how to submit public comments for FDA consideration.
Fixing The Follow-On Insulin Regulatory Approval “Dead Zone”
With all the attention on the costs of pharmaceutical products, there is an upcoming regulatory “dead zone” that will potentially delay market entry of certain insulin products, adversely impacting insulin prices for consumers and payors. A recent Senate bill has been proposed to address this regulatory anomaly. Industry players should monitor this bill and other efforts to address the insulin dead zone, given how critical this product is to so many people.
The Biosimilar Market Is Evolving: How Can Education Strategies Follow Suit?
In this article, I’ll discuss the importance of one commonly overlooked expert and highlight one recent educational initiative that exemplifies current needs in biosimilar communication strategies.
New Medicare Proposals Could Impact Biosimilar Competition
In early January, both Pew and MedPAC presented several suggested changes to current Medicare Part B policy. Though these two organizations' proposals have their differences, the ultimate goal of both is to encourage competition between biosimilars and reference products, which would help with affordability for biologics.
Celltrion: Data Transparency Imperative For Biosimilar Success
Over the past year, the biosimilar industry has developed two mantras: “education, education, education,” and “strategy, strategy, strategy.” But after my conversation with HoUng Kim, the head of the strategy and operations division for Celltrion Healthcare, I’d like to add another mantra to this list: “data, data, data.”
Interchangeability: Have Biosimilar Makers Been Set Up To Fail?
Last week, the Journal of Managed Care & Specialty Pharmacy (JMCP) published research revealing current pharmacist perceptions on biosimilar naming. A number of media resources have leapt on the findings of this study as indicative of a potential danger the naming system alone could cause. But I feel as though these results speak to a greater issue with interchangeability that is worth examining a little more closely.