Generics Bulletin - News And Expert Analysis On Generics And Biosimilars since 2003

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.

Henlius has reported progress in its development of a bevacizumab product for treating ophthalmic diseases, with its Essex-partnered HLX04-O candidate meeting its primary endpoint in a Phase III trial. Meanwhile, Outlook Therapeutics has taken another shot at getting its own ophthalmic bevacizumab approved in the US after resubmitting its filing.

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Doubling down on previously shared data from the firm’s STELARIS trial, Teva has reported further findings from a survey featuring subjects and professionals involved in the Phase III study for its proposed long-acting olanzapine injectable.

Cipla has bolstered its ophthalmology portfolio and increased its global offering after chalking up an agreement to add Formosa Pharmaceuticals’ USFDA-approved clobetasol propionate 0.05% ophthalmic suspension.

Amneal has spoken excitedly about its Crexont (carbidopa/levodopa) extended-release capsules as the Parkinson’s disease drug passes six months on the market.

Following steady updates on its development of a new formulation of valacyclovir, Hyloris revealed the US FDA’s acceptance of its NDA filing while also announcing three new deals this month.

Sandoz has reached an agreement with AbbVie to dismiss without prejudice patent-infringement litigation involving more than 20 patents shielding the originator’s blockbuster JAK inhibitor Rinvoq.

After Amgen’s surprise launch of the first US biosimilar to Eylea last year, expectations around competition are being further upended with the news that Biocon Biologics has struck a settlement deal with Regeneron allowing it to launch its own aflibercept rival in the second half of 2026. Will other challengers follow suit?

Having failed in US patent litigation over Amgen’s Enbrel, Sandoz is taking an alternative approach in trying to get its Erelzi biosimilar to market in the US ahead of patent expiry in 2029: launching an antitrust attack against the originator for “unlawfully extending and entrenching its monopoly."

Jazz has agreed a nine figure settlement agreement in the US with purchasers of its Xyrem blockbuster following claims that it illegally delayed generic competition to the blockbuster treatment for narcolepsy via patent-litigation settlement agreements with several ANDA sponsors.