• Stay up-to-date on all the recent updates with the AMCP dossier Format v5.0 resources 
• Available now: AMCP webinar hosted by FormularyDecisions, “Bracing for the impact of biosimilars: Navigating terrain in the U.S. market landscape”
• New and enhanced features: eRequest update 

The Cencora team has received many questions regarding the changes to the AMCP Format and how it will affect current and future dossiers. Our AMCP dossier experts are offering an informal 30-minute call to provide an overview of the key changes within AMCP v5.0 and to answer any questions that you may have regarding this update.

We are also able to share insights into opportunities for new evidence generation and product differentiation with the new Format. 

Interested in learning more? Connect with one of our dossier experts. 

With the Format v5.0, AMCP expanded its guidance on pre-approval information exchange (PIE). Since the passage of the PIE Act of 2022, AMCP has encouraged pharmaceutical manufacturers to use the Format to proactively share pre-approval information with HCDMs. 

Here, Ben Penley, Manager, Evidence Generation & Value Communications, answers questions about his research, which was presented at AMCP 2024, on HCDM perceptions of PIE after the passage of the PIE Act.

Webinar: Bracing for the impact of biosimilars: Navigating terrain in the US market landscape 
Recorded on: June 11, 2024 
Hosted by: FormularyDecisions 

Watch this engaging discussion to discover the keys to thriving in the dynamic biosimilars landscape. In this session, you will gain practical insights on navigating regulatory challenges, seizing opportunities for collaboration, and communicating effectively with stakeholders. Stay ahead of the curve with up-to-date industry trends and expert strategies tailored to driving success in the US biosimilars market. 

Learning objectives: 

• Review the US biosimilars market landscape and the current legislative and regulatory environment 
• Identify key factors affecting payer uptake and provider adoption of biosimilars in the US 
• Explore challenges and opportunities associated with biosimilars for stakeholders across the healthcare continuum 
• Position yourself for success by leveraging expert strategies and insights to proactively address potential market challenges 

Improvements made to eRequest 
Several enhancements were made to eRequest earlier this month, enabling HCDMs to provide clearer, more specific requests to your team. With this update, all eRequests moving forward will include the following detail: 

Type of eRequest: 

• eDossier requests will specify the disease state of interest, making eRequests easier to fulfill and ensuring the correct information is provided 
• Other information requests will be tracked separately from eDossier requests and include a short explanation from the HCDM 

Follow-up preference: 

• HCDMs will also indicate whether they would like a follow-up meeting to discuss their request 

This eRequest update has already been reflected in your eRequest emails and inbox notifications. Additional improvements will also be released into your Insights Dashboard later this summer, including enhanced visuals that reflect the new level of detail behind each eRequest. 


Don't hesitate to contact us below if you have any questions about the eRequest updates.