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Report Workshop Biosimilars

Title of event/ activity:

Biosimilars: from the gene to the product

Date:

28.02/01.03.2013

Location:

Leukerbad and Lonza Visp, Switzerland

Short description of the event:

The development of biosimilars increasingly plays a role in the pharmaceutical industry and will become even more important within the coming years with several patents, especially on blockbusters, running out. The seminar provided a platform for the exchange of knowledge among experts from the industry and the participants and gave an insight on the up to date situation of the market and of technical and regulatory aspects of the development of a biosimilar. After having arrived in Visp, a bus took the group to the picturesque village of Leukerbad in the middle of the Swiss Alps. The seminar started with an overview of the current biosimilar market and its projected value within the next 10 years. Next, the early development of a biosimilar was presented, showing how clones and master cell banks are generated. Following R&D aspects, the benefits of using process simulations in the planning of a manufacturing facility were shown based on a case study. Finally, regulatory aspects were discussed. On the second day, Lonza presented on site in Visp the advantages of outsourcing production to a CMO and elaborated on the process proceedings. The seminar was completed with the visit of the Lonza biopharmaceutical production facility in Visp. The group of participants was very diverse and included people from production as well as R&D and marketing. During the seminar, discussions between speakers and participants were very lively and fruitful and were continued till late in the evening.

What is the key benefit of your event, initiative, or other?:

The event provided a good overview on the current development of biosimilars. From analysis over research development and regulatory considerations to the final production with CMOs, the entire process was covered. Participants were thereby helped with the decision whether or not to move into the biosimilars business. Speakers (name+ company):

Dr. Gerrit Hagens – RidePharm Consulting Dr. Cori Gorman – BioXpress Dr. Ingrid Hutter – pixon engineering AG Dr. Curt Scribner – RRD International Dr. Christine Bernegger – Lonza AG Dr. Diego Schmidhalter – Lonza AG

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Frank Laukel - Lonza AG

A quote from participant(s): There was a good mixture of speakers with thematically diversified talks. The great location and the friendly atmosphere provided an ideal ambience.

Photographs (With full names and clear legend when specific persons featured):

Figure 1: Biosimilars – From the gene to the product. Participants listening to talks on the first day.

Figure 2: Panoramic view from the Hotel. The village Leukerbad with the Daubenhorn and the Gemmi in

the background.