Update Biosimilars 2026
Regulatory Strategy in a Transforming Landscape
- Intensive training on biosimilar development
- Update Pharma Reform & Biotech Act
- Global strategy & convergence
- Officially certified according to ISO 9001 and 21001
Online-Seminar
From
790,00 €
plus VAT
Services & Process
Veranstaltung - 790,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
9:00-13:00 CET
Booking details
Online-Seminar
From
790,00 €
plus VAT
Services & Process
Veranstaltung - 790,-€ zzgl. MwSt.
The participation fee includes downloadable documentation, a certificate, access to the Learning Space and technical support including PreMeeting.
Period:
9:00-13:00 CET
This seminar covers the key regulatory shifts shaping the biosimilars landscape in 2026. Explore how the revised EU pharmaceutical legislation, the EU Biotech Act, and global regulatory convergence impact your biosimilar development and market entry strategy.
Your speakers
Dr. Karsten Roth
Polpharma Biologics International, SWITZERLAND
Head of Clinical Development;
Karsten Roth is a development professional with 30 years’ experience. For the last 6 years he leads the clinical development…
Your speaker
Dr. Karsten Roth
Polpharma Biologics International, SWITZERLAND
Head of Clinical Development;
Karsten Roth is a development professional with 30 years’ experience. For the last 6 years he leads the clinical development activities at Polpharma Biologics International overseeing the biopharmaceutical and Biosimilar development programs. In addition to his responsibilities at Polpharma Biologics, he is the Vice-Chair of the Biosimilar Medicines Group, at Medicines for Europe in Brussels, Belgium representing several global companies of the Biosimilar sector.
Dr. Axel Korth
Corporate Counsel - Commercial, Biocon Biologics, London, ENGLAND
Dr. Axel Korth is a senior life sciences lawyer with experience both as an in-house legal counsel as well as in private practice. Axel…
Your speaker
Dr. Axel Korth
Corporate Counsel - Commercial, Biocon Biologics, London, ENGLAND
Dr. Axel Korth is a senior life sciences lawyer with experience both as an in-house legal counsel as well as in private practice. Axel Korth is currently working as Corporate Counsel at Biocon Biologics providing legal and compliance-related advice to Biocon's EU business operations. Prior to joining Biocon Biologics, Axel worked at as Assistant General Counsel at Shionogi and Senior Legal and Regulatory Affairs Advisor at EUCOPE representing the organization at the EC, EMA, HMA, CMDh and other fora with a focus on regulatory and legal affairs. Prior thereto, Axel worked as Head Legal DACH at Biogen with a focus on market access, pricing and reimbursement, general healthcare law and compliance, antitrust and competition, public policy and government affairs. Axel also worked in commercial legal roles as Head Legal MEA and Senior Legal Counsel WEMEA at Sandoz (Novartis group) and held positions of continuing seniority at international law firms Shearman & Sterling LLP and Taylor Wessing.
What to Expect
- EU Pharma Reform 2026: implications for biosimilar development and lifecycle planning
- Revised exclusivity, Bolar exemption and patent-linkage
- EMA expectations on (pre)clinical development and comparability
- EU Biotech Act: incentives, manufacturing capacity and investment initiatives relevant for biosimilars
- Global convergence: international streamlining of regulatory requirements
Who Should Attend
This online seminar is designed for regulatory affairs professionals involved in biosimilar development, submission planning or lifecycle management. It is also suitable for colleagues from clinical development, CMC/biomanufacturing, patent/IP, market access and project management who contribute to strategic decisions and timelines.
Participants are expected to have a solid understanding of EU regulatory procedures.
Objective of the Event
This online training provides a compact, practice-oriented update on the regulatory and strategic developments that shape biosimilar projects in 2026.
Using the EU Pharma Reform and the EU Biotech Act as a guiding thread, you will explore what is already clear, where uncertainties remain, and how to translate the evolving framework into robust development and market-entry planning.
By the end of the seminar, you will be able to adapt your current regulatory strategy, identify the most relevant risk drivers for timelines and evidence generation, and derive concrete next steps for your biosimilar portfolio and global planning.
Your Benefit
- You gain clarity on the most relevant policy and regulatory developments in 2026 for biosimilars
- You learn how to turn new patent and market entry rules into a competitive biosimilar strategy
- You receive practical guidance to align EU and non-EU requirements for a streamlined global approach
Programme
9:00-13:00 CET
09:00
09:15
Dr. Axel Korth, Dr. Karsten Roth
- Revised exclusivity: New windows for biosimilar entry
- Patent linkage ban and expanded Bolar exemption: Paving the way for "Day 1" market entry
- EMAs vision: Adapting the (pre)clinical development to minimize time to market
- From guidance to regulation: What the EU Pharma Reform must deliver to close the gap
10:30
10:45
Dr. Axel Korth, Dr. Karsten Roth
- Accelerating biosimilar development through regulatory guidance
- SPC Extension - impacts on biosimilar development
- Clearing patent thickets: "Clear, confirm & control" system for greater market entry certainty
- Expansion of the biomanufacturing capacity & EU health biotechnology investment pilot
11:45
12:00
Dr. Axel Korth, Dr. Karsten Roth
- 20 years of biosimilars - where it started, where we are
- International streamlining of regulatory requirements (EMA, MHRA, FDA, Health Canada...)
- Interchangeability: MHRA & FDA paved the way - and EMA?
- Challenges & Opportunities for your global strategy
12:45
13:00
Introduction and technical warm-up
09:15
EU Pharma Legislation & Beyond - Where We Stand and What's Still Missing
EU Pharma Legislation & Beyond - Where We Stand and What's Still Missing
Dr. Axel Korth, Dr. Karsten Roth
- Revised exclusivity: New windows for biosimilar entry
- Patent linkage ban and expanded Bolar exemption: Paving the way for "Day 1" market entry
- EMAs vision: Adapting the (pre)clinical development to minimize time to market
- From guidance to regulation: What the EU Pharma Reform must deliver to close the gap
Coffee break
10:45
EU Biotech Act and Its Impact on Biosimilars
EU Biotech Act and Its Impact on Biosimilars
Dr. Axel Korth, Dr. Karsten Roth
- Accelerating biosimilar development through regulatory guidance
- SPC Extension - impacts on biosimilar development
- Clearing patent thickets: "Clear, confirm & control" system for greater market entry certainty
- Expansion of the biomanufacturing capacity & EU health biotechnology investment pilot
Coffee break
12:00
Global regulatory Convergence
Global regulatory Convergence
Dr. Axel Korth, Dr. Karsten Roth
- 20 years of biosimilars - where it started, where we are
- International streamlining of regulatory requirements (EMA, MHRA, FDA, Health Canada...)
- Interchangeability: MHRA & FDA paved the way - and EMA?
- Challenges & Opportunities for your global strategy
Final discussion & wrap-up
End of the seminar
Downloads
Request the documents using our form.
Brochure
Weitere Informationen
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.
Access to and procedure for online events
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.
Our Recommendations
Further Information
Your Contact Person
We are happy to advise you personally and individually.
Jean-Marie Bayhurst
Conference Manager
+49 6221 500-685
j.bayhurst@forum-institut.de