2026-06-19 2026-06-19 , online online, 1,290 € plus tax Dr. Barthold Deiters https://forum-institut.com/seminar/26092000-market-access-of-biosimilars-in-europe/referenten/26/26_09/26092000-market-access-of-biosimilars-in-europe_deiters-barthold.jpg Market Access of Biosimilars in Europe

Biosimilar uptake in Europe, Aut idem in Germany - these are the challenges for regulatory affairs and market access

Topics
  • Biosimilars markets in Europe: Navigating market access barriers
  • Demand-side measures to ensure biosimilar uptake in Europe
  • Aut idem in Germany - the current rules
  • Tenders including Biosimilars
  • Regulatory update Biosimilars - current status of authority guidances


Who should attend
This training course is aimed at regulatory affairs and market access specialists in the pharmaceutical industry who bring biosimilar products to the market. It is also of value to all those working in health insurance companies dealing with pharmaceuticals in their work.
Aims and objectives
This training course provides comprehensive insights into the European biosimilars landscape. Participants will gain a deep understanding of current market dynamics, regulatory frameworks, and access strategies across Europe, with a special focus on recent developments in Germany.

By the end of this course, you will be equipped with practical knowledge of regulatory and market access pathways for biosimilars in Europe and know how the new rules in Germany affect your market access and healthcare management.
Your benefit

  • Biosimilars in Europe - current strategies to enhance the uptake
  • Aut idem in Germany - how the biosimilar business is changing here
  • Current status of authority guidances and the impact on regulatory affairs

26092000 Seminar Market Access of Biosimilars in Europe

Market Access of Biosimilars in Europe

Benefits
  • Biosimilar uptake in Europe - how to enhance?
  • Aut idem in Germany - the current rules
  • Current status of authority guidances
  • Officially certified according to ISO 9001 and 21001

Webcode 26092000

Book now

JETZT Buchen

Speakers


Everything at a glance

Appointment

28/09/2026

28/09/2026

Period

09:00-17:00 CE(S)T

09:00-17:00 CE(S)T
Venue

online

online

Fee
Your contact

Dr. Henriette Wolf-Klein
Department Manager

+49 6221 500-680
h.wolf-klein@forum-institut.de

Details

Biosimilar uptake in Europe, Aut idem in Germany - these are the challenges for regulatory affairs and market access

Topics

  • Biosimilars markets in Europe: Navigating market access barriers
  • Demand-side measures to ensure biosimilar uptake in Europe
  • Aut idem in Germany - the current rules
  • Tenders including Biosimilars
  • Regulatory update Biosimilars - current status of authority guidances


Who should attend
This training course is aimed at regulatory affairs and market access specialists in the pharmaceutical industry who bring biosimilar products to the market. It is also of value to all those working in health insurance companies dealing with pharmaceuticals in their work.

Aims and objectives

This training course provides comprehensive insights into the European biosimilars landscape. Participants will gain a deep understanding of current market dynamics, regulatory frameworks, and access strategies across Europe, with a special focus on recent developments in Germany.

By the end of this course, you will be equipped with practical knowledge of regulatory and market access pathways for biosimilars in Europe and know how the new rules in Germany affect your market access and healthcare management.

Your benefit

  • Biosimilars in Europe - current strategies to enhance the uptake
  • Aut idem in Germany - how the biosimilar business is changing here
  • Current status of authority guidances and the impact on regulatory affairs

Detailed programme

09:00-17:00 CE(S)T

Opening address


Prof. Dr. Steven Simoens

Key note: Biosimilar markets in Europe: Navigating market access barriers and sustainability challenges

Short Break


Meike Madelung, MBA

The European Biosimilars market: trends, dynamics and opportunity

Coffee break


Dr. Sabine Vogler

Demand-side measures to ensure biosimilar uptake in Europe and its impact
  • Biosimilar substitution, prescription guidelines and quotas, gainsharing and further measures: Overview of 32 European countries and case studies
  • Impact on uptake of biosimilars: Findings from the AUGMENT project

Lunch break


Dr. Petra Nies

Aut idem in Germany - the rules specified in the Pharmaceuticals Directive (AM-RL) of the Federal Joint Committee (G-BA)

Short break


Dr. Barthold Deiters

Tender including Biosimilars in Germany

Sumir Trivedy

Biosimilar substitution in the EU - status quo, challenges and regulation framework: An industry perspective
  • Biosimilar substitution regulation in Germany compared to other EU countries
  • Best practice policy measures to achieve a sustainable Biosimilar health care environment

Coffee break


Dr. Elena Wolff-Holz

Regulatory update Biosimilars - current status of authority guidances
  • Fostering Biosimilars development, the regulatory landscape (Europe, the US and worldwide)

Conference end


Ihr Nutzen

Technical requirements

You need a reliable Internet connection to take part in our online events. To have the best possible learning experience, we recommend that you use the latest version of the Microsoft Edge or Google Chrome browsers. You will need a headset, loudspeaker or telephone to play the audio. Further information is available here. Please check beforehand that your microphone or headset and camera are working properly. Do not access our services from a VPN since there are issues with the audio over such connections.

We have integrated Zoom video conferencing software into our Learning Space for our online training courses. If you are not authorised to use Zoom, please get in touch with us so we can make alternative arrangements for you to take part in our online training.

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Once you have registered for an event, we will send you the access information for your customer portal. Click here to log in to the customer portal using your email address and password. Please ensure you can access the customer portal before the day of the event.

All important or additional information and personal documents are available in your personalised customer portal. This is also where you start your online courses. If you do not have access to the customer portal yet, you can easily register here.

On the day of the event, you kick off your online training in the customer portal by clicking ‘Participate’ directly in the respective event. You will then be redirected to the Learning Space.

Learn more about our online events here.

Free pre-meeting and technology check

You can attend one of our pre-meetings and explore our Learning Space free of charge. Registration is not required. You can find available dates for a pre-meeting in your customer portal. Click the green ‘Participate’ button in the pre-meeting in the customer portal and you will be redirected to the Learning Space.

The pre-meeting gives you the opportunity to explore our Learning Space and to familiarise yourself with the technology to start off your online training on the right foot. This is a non-binding offer for all our customers and not a prerequisite for participation. If a pre-meeting date does not suit you but you would still like a technology check, please contact us.

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