Policy & Regulation

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.

The Association for Accessible Medicines has urged the Trump administration not to impose proposed tariffs on the off-patent drug sector to avoid drug shortages and additional costs for manufacturers.

While the AAM encouraged CMS to impose its “clear authority” to regulate Medicare Part D formularies, the agency announced that the Trump administration will continue the second cycle of Medicare price negotiations, which has been criticized by the US off-patent trade group.

Celltrion may consider establishing or acquiring US manufacturing facilities as well as securing more US inventory and shifting its focus onto drug substance rather than drug product imports, the Korean biosimilars giant has suggested, as it sought to assuage investor concerns over pharmaceutical tariffs announced by US president Donald Trump.

China’s National Healthcare Security Administration has responded to reports of complaints from Chinese healthcare professionals about the quality and efficacy of generics purchased through the country’s volume-based procurement scheme.

The FDA’s CDER has set out a 2025 guidance agenda that promises long-awaited guidance on first interchangeable biosimilar exclusivity, as well as a host of other documents relevant to generic drug development and registration.

Generics Bulletin reviews global regulatory developments from late 2024 and new updates from this year.

New US president Donald Trump’s pick for HHS secretary, Robert F. Kennedy Jr, has been sent a slew of questions by senator Elizabeth Warren that touch on a number of areas of relevance for generics.

Responding to the announcement by the US Centers for Medicare & Medicaid Services of the 15 additional drugs that will soon be subject to price negotiation – including Ozempic, Rybelsus and Wegovy – the Association for Accessible Medicines has called out the “short-sighted government price setting scheme” for undermining generic and biosimilar competition.

Stelara, Xarelto, Januvia and Farxiga, which are expected to have biosimilar or generic competition before the end of 2026, could be the first negotiated drugs subject to the policy.

Chairman-designee Andrew Ferguson likely will continue the commission’s investigation of PBMs during the next administration.

New legal issues in the biosimilar space continue to slow guidance development as industry pushes for more agency transparency on its thinking.