Description
On 22 & 23 March 2018, Porto will host the 2nd BioTech Pharma Summit: Biosimilars & Biologics 2018. This year’s flagship event will gather top EU, US, Asia and global regulators, officials, healthcare actors as well as industry leaders, to foster open exchange and debate on the role of the biosimilars & biologics medicines sector.
Over 200+ proteins, peptides and biosimilars delegates representing leading biotech companies, global pharmaceutical organisations and internationally renowned academic institutions at the Biosimilars & Biologics 2018
With more U.S., Europe biosimilars continuing to receive FDA/EMA approval, it is critical that bio/pharmaceutical companies develop strategies to comply with evolving regulations, mitigate risk and execute long-term decisions to prepare for success.
Over 20 presentations and case studies focusing on the key areas of the biosimilars industry including market access strategies, clinical development, commercialisation, manufacturing and bio-analytics
Biosimilars will lead to $54 billion less in direct spending on biologics (or about 3% of total spending on biologics) over the next decade. The range of the new savings estimate given reasonable ranges of key assumptions, such as the price of biosimilars versus reference biologics and biosimilar market share, varied from $24 billion to $150 billion from 2018 through 2027.
The BioTech Pharma Summit: Biosimilars & Biologics 2018 is the leading event to continually stay on the pulse of the biosimilars’ ever-changing market and convenes key stakeholders including biosimilar and innovator pharmaceutical manufacturers, payers, providers and patient advocates addressing timely challenges and best practices for biosimilar product success
Key Practical Points
- Interchangeability strategy in Biosimilar clinical trial
- Biosimilar development in emerging markets
- CMC Analytical Comparability: Methods & Strategies for Biologics, Biosimilars & Biobetters
- Prognosis for the Global Biologics market in an era of transformative new technologies
- Innovative clinical approach in biosimilars
- Critical Analytical Characterization Steps for Biosimilarity Assessment
- Process Development for Biosimilars - Industry challenges
- Biosimilars development and impact on clinical practice
- Impact that biosimilars make on availability of biologicals on ROW markets
- Biosimilar approval to biogenerics in clinical practice
- Pricing and reimbursement considerations for Biosimilars
- Commercial challenges and opportunities - strategies to develop Biosimilars & Biologics
- Developing successful business models in Biosimilar product development
- Understanding the current regulatory approval standards for Biosimilars in Europe, US and ROI including for monoclonal antibodies
- Injection Devices for Biosimilars: Advantages of Platform Products
Key Speakers
Steinar Madsen
Medical Director at Norwegian Medicines Agency
Anna Aillerie
Head of Commercial Operations, Biotechnology at Gedeon Richter
Bryan Kim
Vice President of Business Development at Samsung Bioepis
Joanna Brougher
Owner & Principal at BioPhama Law Group, PLLC
Thanks to our Sponsors
Hotel Venue
The Yeatman Hotel*****
The Best views over Porto & the Douro River
A great classic hotel defines a destination, providing an authentic and memorable sense of place. The magnificent World Heritage city of Porto is defined by such an iconic property. The Yeatman Hotel.
Occupying a breathtaking position overlooking the Douro River and the historic city centre, The Yeatman enjoys stunning panoramic views from its extensive grounds and individually appointed guest rooms with their own private terraces. A haven for wine lovers and those wishing to explore the fascinating world of Port and other wines from Portugal’s best producers. The Restaurant favours the importance of food and wine pairing and both the restaurant and wine list have won prizes including a Michelin star.
Member of the prestigious Relais & Châteaux collection of hotels and distinguished with a Michelin Star for its restaurant under the direction of Chef Ricardo Costa, The Yeatman Hotel in Porto is a unique and distinctive landmark in the world of classic luxury hotels.