Regulation

Generics Bulletin reviews the latest regulatory developments across the world.

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.

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.’

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.

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.

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.

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

We review the most notable regulatory developments of the past year, with experts outlining for Generics Bulletin the regulatory to-do list for 2025.

The rush to submit applications before user fees increased may have motivated the sudden drop, a generic industry trend that continues to grow.

A few months after a positive Phase III trial readout, Henlius has filed an application for its Organon-partnered Perjeta biosimilar in its domestic Chinese market.

Generics Bulletin reviews the latest developments in the regulatory arena across the globe.

An increase in complex product submissions may explain median and mean approval time increases for ANDAs, but fewer actions across many categories could be a concern.

The US PTO is facing criticism after withdrawing a proposed rule that sought to address double-patenting with changes to terminal disclaimers.

Despite the US legislation gaining support from Democratic candidates, who have fought against anticompetitive pharma behavior, many have shared concerns that the amended PREVAIL Act will still negatively impact generic drugs.

The latest update on product-specific guidances for generic development from the FDA included 60 new and newly-revised PSGs as well as an update on future guidances coming down the line in the next year.

Medicines for Ireland had its demands for the off-patent sector heard by some political parties, which are pledging to improve access to generic and biosimilar drugs ahead of the election.