Medicines for Europe
While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.
Four key areas for policy reform were identified by industry association Medicines for Europe at its biosimilars conference in early April, as sector chair Isabell Remus set out the importance of removing barriers to biosimilar competition.
The EMA’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam. Generics Bulletin discusses the new draft reflection paper and its significance for industry, reports on reactions from the event, and reveals the next steps unveiled by EMA officials.
As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.
Tariffs, international cooperation, and war: the off-patent industry is not immune to the political issues raging across the globe. Medicines for Europe’s Adrian van den Hoven and Beata Stepniewska spoke with Generics Bulletin about what these developments mean for the sector.
2025 is likely to be a game-changing year for the pharmaceutical industry. Generics Bulletin sat down with Medicines for Europe’s Adrian van den Hoven and Beata Stepniewska to discuss the opportunities of the Critical Medicines Act and EU pharmaceutical legislation revision.
Generics Bulletin previews the most noteworthy and anticipated events for February 2025.
Generics Bulletin’s editorial team discusses recent conferences held by Medicines for Europe and the AAM, while looking ahead to the key off-patent industry events that are on the calendar over the next few months and beyond.
At a panel on value added medicines at Medicines for Europe’s 30th annual conference in Dublin, Pharmanovia CEO and value added medicines sector chair James Burt set out the case for expanding the scope of current EU pharma legislation proposals to reward reformulation alongside repurposing.
At a high-profile panel closing out Medicines for Europe’s 30th annual conference in Dublin, six industry leaders set out their views on key topics including pricing, regulation, sustainability, and stakeholder communication.
European solidarity and dialogue will be key as the region seeks to secure its supply of critical medicines, says Victor Mendonça, board member of Medicines for Europe. In an exclusive interview, he speaks to Generics Bulletin about what can be done to strengthen Europe’s supply chain without “one country’s solution being another country’s problem.”
The European Critical Medicines Alliance must lead to a Critical Medicines Act to support the off-patent industry and help reduce shortages, Medicines for Europe believes.
With a fresh pricing deal on the horizon, Medicines for Ireland chair and Teva country head Paul Neill talks to Generics Bulletin about the need for the Irish off-patent industry to have “a true seat at the table” and secure an agreement with the country’s government that better reflects the specificities of the generics and biosimilars market.
While the European supplementary protection certificate manufacturing waiver was once seen as a triumph for the region’s off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe’s legal affairs conference in Dublin last week heard the latest.
While the European SPC manufacturing waiver was once seen as a triumph for the region’s off-patent industry, concerns are now being raised over how the mechanism is implemented. Attendees at Medicines for Europe’s legal affairs conference in Dublin last week heard the latest.
At Medicines for Europe’s 30th annual conference in Dublin last week, the European association and its Irish counterpart provided an overview of the challenges and opportunities facing the European off-patent industry.
Europe’s biosimilars market now has many years of progress under its belt. But how can this successful foundation be built upon to make the most of the opportunities on the horizon and achieve even greater access and uptake? In an exclusive interview, Generics Bulletin talks to Medicines for Europe’s Isabell Remus and Julie Maréchal-Jamil about the next steps.
Speaking at Medicines for Europe’s 20th annual biosimilar medicines conference, Isabell Remus, chair of Medicines for Europe’s biosimilar medicines sector group, looks to the future for European biosimilars over the next decade and outlines the potential that can be realized – but only if a comprehensive strategy for biosimilars is put in place.