Strategy

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.

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

Fresenius Kabi is drawing closer to the conclusion of its Vision 2026 strategic roadmap. The company’s CEO, Pierluigi Antonelli, talks to Generics Bulletin about the company’s results so far and how it’s investments in biosimilars, acquisitions and manufacturing is paying off.

Speaking as Hypera delivered its full year-results, CEO Breno Oliveira has set out plans for the Brazilian firm to launch an Ozempic rival in its domestic market next year. Meanwhile, the company is dealing with increasingly aggressive local generic competition.

Months on from penning a landmark commercial and manufacturing agreement for GLP-1 assets with Metsera, Amneal says it is happy with how the partnership is shaping up.

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.

Stada has set out annual results that it says demonstrate that the German firm is outperforming the market in all of its business segments, with the company breaking the €4bn sales barrier for the first time. The results come ahead of a long-awaited potential IPO that conflicting rumors suggest could either come very soon indeed, or may be delayed until later this year.

South Africa’s Aspen Pharma has discussed the “significant progress” it believes it has made in GLP-1s, with an eye on rolling-out semaglutide in non-US and non-EU markets beginning as early as 2026.

Both vexed by bankruptcies and opioid litigation, Endo and Mallinckrodt will merge in a deal valued at $6.7bn. The new company will spin out its generics and sterile injectable business.

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.

Gedeon Richter enjoyed a solid 2024 as it capitalized on key generic launches and progressed significantly with proposed biosimilars to both Prolia/Xgeva and Actemra/RoActemra. The Hungarian firm also shed light on its strategy over the next decade in a newly-launched ten-year strategic plan.

Lupin has moved quickly to begin rolling out the first generic version of the blockbuster blood thinner Xarelto in the US, despite continued legal action over a patent expiring in 2039.

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.

Lupin and Sun Pharma’s Taro, which have just won the first US Food and Drug Administration approvals for generics to J&J/Bayer’s blockbuster Xa inhibitor Xarelto, remain locked in litigation over a patent expiring in 2039.

Marking International Women’s Day, Generics Bulletin speaks to Accord’s UK country manager Clara Carter about her role as chair of the BGMA’s new Women’s Networking Group.