The first presentation 'EVA - the Basel Life Sciences Start-up Agency' and the Basel Spin-off Incubator, given by Dr. Peter Burckhardt, was topical given the location of the event. Since 2011, the Basel Technology Park has been encouraging innovative new companies from various technology sectors. Dr Burkhard explained how Basel as a whole offered various mechanisms to new companies for financing and support, whilst also giving a realistic picture of the obstacles to be overcome.
The next presentation centred on biosimilars, with Dr. Katrin Appenzeller and Dr. Anna Barbara Stalder offering a perspective from the view of Swissmedic. They gave a thorough overview of developments that are shaping the field of biosimilars and the way in which different regulators around the world are approaching this subject. With 8 biosimilars having been approved since 2008 by Swissmedic (and a further 4 biosimilars currently under review), the Agency has gained considerable expertise in this area of regulation, which has led to various guidelines and documentation, including the Administrative ordinance Authorisation of similar biological medicinal products (Biosimilars). They explained how a step-wise approach to gain evidence on similarity between the biosimilar candidate and the reference product was used and that it was the totality of evidence that was the important factor for regulatory decision-making. While Swissmedic was very much in line with the general thinking of other major regulators, such as EMA, the Agency stressed that there were particular situations that would make the Swiss situation unique. Therefore it was critical for manufacturers working in this field to engage early on with Swissmedic with respect to any product-related regulatory matters and not to make automatic assumptions based on experience elsewhere, such as in the EU. Furthermore, the speakers encouraged the delegates to consult the Swissmedic website for more information and to keep abreast of developments.
Finally, Dr. Frank Wierckx from Clinipace offered an industry view of the situation for biosimilars in Switzerland. He outlined the challenges that companies had experienced while the regulatory framework had been in transition and the practical difficulties they might face in meeting new requirements. One of the areas that companies needed to pay particular attention to was for the reference product, as the ideal situation would be for a biosimilar to be compared with the originator product approved in Switzerland. Otherwise proof would be needed that the product used for the comparison of the biosimilar with the originator product was identical to the product approved in Switzerland. The limitations in information available to the manufacturer might impact their ability to meet such requirements. Dr. Wierckx then explained the approach needed for a realistic development strategy, and the necessary features of the quality, non-clinical and clinical data expected. At this point of the presentation, the scope to reduce the burden of nonclinical/clinical studies by providing more extensive and detailed quality data was also discussed. To end the presentation, he briefly reviewed the potential review strategies for the US, EU as well as Switzerland.
The lively discussions during and after the presentations, illustrated the great interest among the delegates concerning biosimilars. The fast moving pace of developments in this field and the ongoing efforts by regulators to introduce appropriate framework suggest that this will be an interesting topic to revisit at a future TOPRA In Switzerland.
To conclude the event, Mr. Christian Harr from the Basel Technology Park gave delegates a unique behind the scenes tour. He explained how the Technology Park offered companies a setting that was particularly suited to the life sciences and showed how some of the recent occupants were benefitting from the expanded facilities and growing support network.
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