From November 9th-11th, ASBM participated in the World Biosimilar Congress 2021 Europe, held in Basel, Switzerland. ASBM was represented at the conference by Advisory Board Chair Philip Schneider and Steering Committee Member Andrew Spiegel, executive director of the Global Colon Cancer Association (GCCA).
The theme of the three-day meeting was “Celebrating 15 years of Biosimilars in Europe.” Professor Schneider chaired the Keynote Panel Discussion titled “Regulatory lessons learned from the past 15 years and what can regulatory guidelines do to improve access going forward.”
Members of the panel included a representatives from the European Medicines (EMA) and drug manufacturers. The perspective that emerged in this discussion is that the issue of interchangeability of biosimilars in becoming less important in the EU and the need for clinical trials for market authorization of biosimilars is decline. It was also agreed that physician and patient involvement in developing regulatory guidelines is important and strong pharmacovigilance programs are essential.
There were several sessions on the topic of sustainability that addressed the need for balance in the efforts to contain costs while maintaining a competitive marketplace by increasing the number of biosimilars and creating new reference products. Schneider chaired the sessions on this topic, gave a presentation titled “Problems with Pharmacovigilance Programs: an Opportunity for Improvement,” and chaired a panel discussion “Creating a sustainable future for biosimilars.” Topics discussed in the panel included the need to included factors other than price such as drug administration devices and supply chain reliability in tender decisions and the pros and cons of gain-sharing programs that are intended to create the incentive to use biosimilars in the clinical setting.
Andrew Spiegel chaired a 3-hour session on Biosimilars in Oncology – which involved introducing the speakers and their presentation topics. He also hosted his own Roundtable on Biosimilars in Oncology, at which the topic of forced biosimilar switching was discussed. The oncologists present expressed their strong opposition to the practice.
Spiegel also hosted two Fireside Chats during the meeting.
The first was with Antonella Cardone
, executive director of the European Cancer Patient Coalition. Its theme was ‘The Importance of Biosimilars in Oncology” and featured patient survey data. “The European patient community mostly in alignment with ASBM members on opposing forced switching and preferring to make treatment decisions with their physicians, said Mr. Spiegel.
The second Fireside Chat was with a representative from a biosimilar manufacturer, Sundar Ramanan, entitled ‘Promoting Equitable Access of Biosimilars Across Therapeutic Areas.”
Read more about the World Biosimilar Congress 2021 Europe here.