Conferences

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.

IGBA secretary general Susana Almeida takes Generics Bulletin through an almost two-decade journey of developing global regulatory convergence and the next goals for the off-patent industry.

As the US marks 10 years since the first biosimilar approval and launch, AAM Biosimilars Council executive director Craig Burton talks to Generics Bulletin about the lessons learned so far and the path ahead, including how to move on from market models that have proved to be “not appropriate” for biosimilars.

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.

In a wide-ranging conversation, the AAM’s president and CEO John Murphy talks to Generics Bulletin about how the US industry association is planning to gain traction with the new Trump administration by adopting “a much more aggressive communications approach” on topics including medicines shortages, trade tariffs, PBM reform, the IRA and biosimilar interchangeability.

A new US presidential administration brings both challenges and opportunities for the off-patent industry. Speaking to Generics Bulletin on the sidelines of the AAM’s annual conference earlier this month, the association’s chair and Sandoz North America president Keren Haruvi discusses how the group plans to make its voice heard on key priorities including tariffs, PBM reform, and regulatory streamlining.

Discussing a new report highlighting the lack of US biosimilar competition on the cards for the majority of biologics losing exclusivity in the next ten years, the AAM’s Access! 2025 conference heard that the “sobering” findings should act as a “wake-up call for stakeholders.”

Trump’s former FDA commissioner sees ‘nothing good’ coming from negotiating a new user fee agreement in the ‘current political environment.’

At a lively AAM Access! conference in Florida this week, the latest actions taken by Donald Trump ranked high on the agenda. But as well as acknowledging the negative effects of potential tariffs, the AAM’s president and CEO John Murphy also suggested that the advent of the second Trump administration could offer an opportunity for the generics and biosimilars sector to make its voice heard on proposed market reforms.

Pushing onwards with its turn to rare disease, ANI discussed its latest plans at this year’s J.P. Morgan Healthcare Conference, setting the scene for further launches in the coming year.

Hikma aims to launch fewer, but more material, products in the coming years as part of a shift in its research and development strategy that was discussed in a Q&A at this year’s Jefferies Healthcare Conference.

Amphastar’s leadership has discussed its strategy and latest results as part of a fireside chat at this year’s Jefferies Healthcare Conference, restating its expectations of potential approvals of its GLP-1 candidate in 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.