Biosimilars

Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.

Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.

With Celltrion having just received approval for its US Actemra (tocilizumab) biosimilar and having just launched its ustekinumab rival to Stelara – and with the introduction of the Korean developer’s denosumab rivals to Prolia and Xgeva just around the corner – 2025 is set to be a busy year, Celltrion USA chief commercial officer Thomas Nusbickel tells Generics Bulletin.

With sales and profits shooting up in 2024, Alvotech has revealed plans to rapidly accelerate development to add between four and six programs to its pipeline of biosimilars every year, while at the same time unveiling details of several new brands that it will be seeking to challenge. The firm has also set out longer-term financial targets that anticipate more than trebling its revenues in the next three years.

India’s Dr Reddy’s and China’s Bio-Thera have struck a deal covering ustekinumab and golimumab biosimilars in multiple markets in south-east Asia.

Fresenius Kabi has met its end of the bargain to launch biosimilars to Prolia/Xgeva in the middle of this year, after bagging FDA approvals. The German firm is also set to hear back on its filings in Europe imminently.

Alvotech and Advanz have announced a UK MHRA filing acceptance for their partnered AVT23 proposed biosimilar to Xolair (omalizumab).

With an ambitious goal to file a biosimilar to the world-renowned Botox brand via the US FDA’s 351(k) regulatory pathway, AEON Biopharma has revealed the latest steps in its plan.

Complaints from UK originator association the ABPI over rising payments required by the country’s voluntary scheme for branded medicines pricing have been denounced by the BGMA, which says the differentiated scheme is “delivering precisely as it was intended.”

Sweden’s Xbrane has struck a deal to transfer its R&D operations in Sweden and its Cimzia (certolizumab pegol) biosimilar candidate to Alvotech, in a transaction worth around $27m. However, Xbrane told Generics Bulletin that it was not getting out of biosimilar development altogether.

With Sandoz set to debut US competition to Prolia and Xgeva in a matter of months, other biosimilar sponsors are working hard to ensure launch of Amgen’s blockbuster in a timely manner.

Fresenius Kabi has become the latest biosimilar sponsor to settle US litigation with Amgen over its Prolia/Xgeva rivals. The German firm revealed to Generics Bulletin details of launch dates for its denosumab in both the US and Europe.

Amgen’s biosimilar aflibercept formulation is keeping it head and shoulders above other would-be Eylea biosimilar competitors, while continuing to frustrate originator Regeneron’s push to block sales of the product while it battles Amgen over alleged infringement of a key US patent.

Biocon Biologics is partnering with Civica to supply insulin aspart drug substance that will be used for final US manufacturing by Civica at its plant in Petersburg, Virginia.

Celltrion has become the latest firm to enter the competitive US market for Stelara biosimilars, revealing details of its Steqeyma launch.

As Coherus prepares to exit the biosimilars space altogether with the divestment of its Udenyca pegfilgrastim franchise, the firm has set out its annual results for 2024 as well as “organizational streamlining” plans.

As the US marks 10 years since the first biosimilar approval and launch, AAM Biosimilars Council executive director Craig Burton talks to Generics Bulletin about the lessons learned so far and the path ahead, including how to move on from market models that have proved to be “not appropriate” for biosimilars.

In the wake of multiple ustekinumab biosimilar rivals to Stelara launching in the US at the end of February, Generics Bulletin’s editors discuss the market dynamics and the latest key developments.

While Celltrion has scooped approval for the first biosimilar to Genentech/Novartis’ Xolair in the US – where the reference product achieved sales close to $3bn last year – Genentech’s parent Roche has stated consistently that it is not expecting to face biosimilar competition in 2025.

In the wake of Formycon’s recent announcement that US marketing partner Sandoz would be pausing commercialization of the Cimerli rival to Lucentis that it recently took over from Coherus, Sandoz management has offered a few more details on its plans for the ranibizumab biosimilar.