Policy & Regulation
The EU’s Critical Medicines Act is finally here. But did the European Commission’s decision to fast-track the legislation result in it falling short?
Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.
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.
Medicines for Europe’s director general described the directive as detrimental to the industry, patients, and the Commission’s ambitions to bolster the supply of critical medicines in the bloc as part of the Critical Medicines Act.
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 the wake of Formycon’s recent announcement that US marketing partner Sandoz would be pausing commercialization of the Cimerli rival to Lucentis that it recently took over from Coherus, Sandoz management has offered a few more details on its plans for the ranibizumab biosimilar.
Sandoz CEO Richard Saynor has spoken of his frustration at a lawsuit from J&J seeking to prevent the launch of a private-label ustekinumab biosimilar in the US, which he described as “the desperate actions of an originator trying to protect its market.”
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.
Two recent disclosures from Xbrane Biopharma and Formycon demonstrate how the US Food and Drug Administration’s thinking is evolving on the necessity of Phase III trials to support biosimilar filings.
Generics Bulletin reviews the latest regulatory developments across the world.
In an update to its strategy for dealing with US tariffs, Korea’s Celltrion has revealed actions taken so far, as well as outlining plans to consider moving “swiftly” to secure US manufacturing for APIs if circumstances demand.
Unleashing a trio of major announcements, Formycon has indicated a gloomy outlook for US Stelara biosimilar pricing; revealed plans to pause commercialization of its Sandoz-partnered US Cimerli rival to Lucentis amid discounting from rivals; and set out ambitious plans to win FDA approval for its proposed Keytruda biosimilar without any Phase III data.
In its latest draft standard contract for 2025/26, the National Health Service in England has proposed enhanced prescribing requirements “in recognition of the increasing importance of biosimilars in the provision of biological medicines.”
A US tariff on imports from China raises the spectre of similar action against India, but Aurobindo, the largest generics company in the US by prescriptions dispensed, assures it has alternatives in place. While trials for an opthalmology biosimilar are delayed, supply of other biosimilars to Europe is set to begin in Q2 FY26.
Momentum is building around the European Commission’s race to propose a Critical Medicines Act, which aims to tackle drug shortages and create a better framework for establishing manufacturing facilities of essential medicines in the EU.
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.