Regulation

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.

When the agency decided biosimilarity standards would be high, it likely ensured the interchangeability designation eventually would become unnecessary.

As China faces the potential loss of a big customer base, the US off-patent industry starts to look for new relationships elsewhere. While building domestic manufacturing capabilities would be the ultimate American dream, the government has yet to offer the carrot, not just the stick.

Running from 11-14 November, the fifth annual Global Biosimilars Week awareness campaign has been launched by the IGBA, with the international off-patent association this year focusing on advancing access.

Despite calls to amend the Urban Wastewater Treatment Directive to protect essential and critical medicines, the EU Council gave its final approval.

Generics Bulletin reviews the latest regulatory developments across the world.

Sponsors of generic drug applications that miss a goal date, but do not receive an action because of complex scientific or legal questions, would get a notice outlining the lingering issue as part of a new pilot program that might become permanent in the next review cycle.

Respondents to the FDA’s questions over biosimilar development did not hold back. So, what is it: product-specific or product class-specific guidance? Or nothing?

Teva has been fined €463m – just over half a billion US dollars – over a breach of EU antitrust rules, after the European Commission found that it abused its dominant position to delay competition to Copaxone, including by misusing the patent system and disparaging rivals. The firm has strongly disagreed with the decision – which is claims is “legally untested” and “not supported by the facts” – and says it will appeal.

In a citizen petition to the FDA, Alvotech has called on the US agency to refrain from approving as interchangeable certain Stelara biosimilars that use a different cell line to its own ustekinumab product – including the Pyzchiva version set to be brought to market by Samsung Bioepis and Sandoz.