Strategy

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.

Aeon Biopharma has picked up Revance Therapeutics executive Rob Bancroft to serve as its new CEO as it continues to pursue a biosimilar version of Botox. Meanwhile, Coherus has lost its chief commercial officer, as Viatris, Sandoz and Medicines for Ireland have announced new appointments.

Sunshine Biopharma is continuing to roll out generic launches in Canada, with its latest product challenging Afinitor and other everolimus rivals in the market.

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.

Aurobindo is set to join Lupin by competing against Johnson/Bayer’s blockbuster blood thinner Xarelto (rivaroxaban) 2.5mg tablets.

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.

Following past challenges on the US market, the Indian pharma player Wockhardt will be shuttering its presence in the country due to commercial reasons.

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."

Cipla will look to give its US operations a boost later this year by launching only the second Abraxane ANDA product.

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.

South Korea’s Celltrion has doubled down on its efforts in further building its pipeline, eyeing a target of 22 commercialized products by 2030 while also aiming to submit INDs for 13 novel compounds.

Samsung Bioepis and Teva have provided clarity on the pricing of their Epysqli biosimilar to Soliris in the US, as the firms launched only the second rival to the rare diseases treatment.

Teva is charting a new course under its ‘Pivot to Growth’ strategy, providing a memory aid for investors to better understand the firm’s financials going into 2025.

Meitheal Pharmaceuticals said that its generic version of the GLP-1 agonist Victoza would be one of 22 planned launches during 2025, as the firm continues to build out its portfolio with the aid of its parent, Hong Kong King-Friend Industrial.

Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.

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.