Biosimilars

Sandoz has struck a deal worth up to $301m with Henlius giving it rights to a proposed ipilimumab biosimilar to Yervoy in countries across the world.

With discounts reaching up to 90%, ustekinumab biosimilars have eroded originator Stelara’s sales as expected. In its latest quarterly biosimilar market report, Samsung Bioepis also analyzed the latest regulatory steps to streamline biosimilar development.

Amid several insights into its expectations of biosimilar competition in 2025, Roche has confirmed the total amount it anticipates being shaved from its top line this year.

With the Global Generics & Biosimilars Awards 2025 taking place in Frankfurt this October, we bring you five key pieces of guidance to help ensure that your entries stand out from the competition.

Denosumab competition is heating up in Europe, with four more companies this month gaining EMA endorsements for their Prolia and Xgeva biosimilar rivals.

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.

Samsung Bioepis has revealed first-quarter figures that reflect recent launches driving growth for the Korean biosimilars developer.

French generics and biosimilar body Gemme has welcomed a call from the country’s audit court to improve uptake for off-patent medicines.

Celltrion’s adalimumab biosimilar was crowned as interchangeable by the FDA, at a time when the future of the designation is unknown.

The challenging US biosimilar market remains a persistent problem, leading the biosimilar developer to reconsider how it invests in the future while pushing for changes.

With six biosimilars reportedly in development, Polpharma Biologics has linked up with Chinese CDMO Chime Biologics, looking to tap its “all-in-one solutions to accelerate biosimilar development and reduce the time-to-market” for an undisclosed biosimilar product.

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.

Coherus has officially marked its exit from biosimilars by completing the divestment of its Udenyca pegfilgrastim franchise. Meanwhile, buyer Accord BioPharma has set out how it expects to benefit not only from a growing asset but also from the Coherus personnel that have moved over.

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?

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.

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."

After having its facility cleared by the FDA earlier in the year, Biocon Biologics finally saw its bevacizumab biosimilar receiving approval in the US.

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.