Combating Bioequivalence Data Fraud: Indian CROs Face Mandatory Registration

 

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’s Susana Almeida On Consensus Building, Harmonization, And Policy Built On Science – Not Politics

 

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.

After A Decade Of US Biosimilars, ‘The Challenges Are Becoming More Clear’

 
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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.

In Discussion With Medicines For Europe: Bracing For US Tariffs And Embracing Ukraine

 

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.


In Discussion With Medicines For Europe: The Year Of The Critical Medicines Act And Pharma Legislation Review

 

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.

‘You’re Going To See A Much More Aggressive Approach’ – AAM Chief Murphy Sets Out Plans To Engage On Tariffs, Shortages And The IRA

 
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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.

‘I’m Focused On The Opportunities Rather Than The Challenges’ – AAM Chair Haruvi Examines The New US Landscape

 
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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.

AAM Stares Into The Biosimilar Void

 
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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.”


User Fees: Industry Should Push For Extension Of Current Agreement In Reconciliation Bill, Gottlieb Says

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

Trump And Tariffs Top AAM’s Access! Agenda

 
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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.

ANI Maintains Course With Rare Disease Push In 2025

 
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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 Discusses Quality Vs Quantity Approach At Jefferies

 
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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 Continues To Push Proprietary Portfolio With Focus On Baqsimi

 
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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.

The Generics Bulletin Podcast: Recent And Upcoming Industry Events

 
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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.

Europe Must Not Squander Potential Of Reformulation

 
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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.

The View From The Top: European CEOs Highlight Industry Priorities

 
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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 Solutions To European Problems – Securing The Supply Of Critical Medicines

 
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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.”

European Alliance Should Lead To Critical Medicines Act, Says Industry

 
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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.

‘A True Seat At The Table’ – Irish Industry Leader Sets Out Aspirations For New Pricing Deal

 
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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.

‘We Tried It, It Does Not Work’ – The Problems With The EU’s SPC Manufacturing Waiver

 
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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.