Policy & Regulation
Cuts to the FDA’s policy and legal personnel have prevented dozens of product-specific guidances for generic drug development from being published.
As the US biosimilars market moves into its second decade, urgent changes are needed at the FDA if biosimilars are to meet their full potential, according to Biosimilars Forum chief executive Julie Reed.
A free trade agreement struck between the UK and India could over “significant benefits for the generic and biosimilar sectors,” Medicines UK believes. The off-patent industry association has also suggested further avenues for collaboration between the two governments on regulatory pathways and supply security.
Dr. Reddy's Laboratories preps for potential US tariffs, focusing on sustaining product supply and collaborating with customers on inventories. A recent US plant sale, the firm stressed, was unrelated to tariffs and underlines its openness to ‘make in the US’, where it launched 18 products in fiscal 2025.
Donald Trump’s executive order on most-favored-nation prescription drug pricing could provide positive opportunities for the off-patent industry, although US generics and biosimilars association the AAM suggested that the administration might do more good by focusing elsewhere.
Commissioner Martin Makary’s repeated characterization of foreign facilities as being subject to lower standards than domestic counterparts may have contributed to Rogers’ decision to retire as head of the recently formed Office of Inspections and Investigations.
An executive order from US president Donald Trump aimed at incentivizing domestic manufacturing of critical medicines has been welcomed by the US Association for Accessible Medicines.
The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.
Reflecting on recent initiatives by NHS England and the MHRA, the newly renamed trade body Medicines UK has welcomed efforts in promoting the use of biosimilars in Britain.
During Organon’s first-quarter results call, CEO Kevin Ali discussed the exposure of the biosimilars business to US tariffs, as well as pointing to the recent acquisition of Tofidence (tocilizumab-bavi) from Biogen as an opportunity for growth, as the segment saw a double-digit decline.
As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.
During the “CEOs Unplugged” panel at the AAM’s annual conference in February, leaders from Sandoz, Lupin and Amneal discussed the various ways in which the US framework is making life difficult for generics and biosimilars.
French generics and biosimilar body Gemme has welcomed a call from the country’s audit court to improve uptake for off-patent medicines.
The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.
The elimination of the policy division at the Office of Generic Drugs, tariffs, the Section 232 investigation, and a new executive order to promote lower drug prices seem to both cause and purport to solve the same problem: supply chain disruption.
In the wake of a report marking 10 years since the first US biosimilar launch, Cardinal Health’s Dracey Poore speaks to Generics Bulletin about the successes seen so far and the obstacles that must be overcome if the market is to thrive in the decade ahead.
Generics Bulletin reviews global regulatory developments across the world.
News of a fresh US investigation into the pharma sector has sparked renewed concerns over the impact that US trade tariffs would have on the generics and biosimilars industry. The AAM has responded with a warning over the potential effects on shortages and access, while Medicines for Europe has proposed five key action areas to bolster the sector in Europe.
The US Senate Judiciary Committee’s Chairman Chuck Grassley criticized the Senate’s reduced working hours as six previously introduced bills once again land on their desk.
Massive layoffs and the biosimilar user fee program’s historic flirtation with the non-user fee spending requirements raise concerns that the FDA could lose its ability to collect BsUFA revenue, which could mean a fine or jail time for agency staff.