Strategy
The FDA rejection of Alvotech’s AVT06 Eylea biosimilar was revealed as part of a wider funding update outlining a $108m bond placement and continued heavy R&D investment.
UK liquids specialist Rosemont Pharmaceuticals has named industry veteran Alok Sonig as its new CEO, as the firm continues to set its sights on the US market. Meanwhile, Rosemont has also appointed Gavin Wood as chief financial officer.
After years of regulatory setbacks, Amphastar has secured FDA approval for its first pen device combination product, targeting a $585m Forteo market.
Sandoz said it was “asserting biosimilars leadership” as it announced the completion of a deal to acquire Just-Evotec Biologics’s Toulouse development and manufacturing site as well as an indefinite licence to the firm’s continuous manufacturing technology.
The launch of Tyzavan, a ready-to-use vancomycin premix, comes amid plans to accelerate growth for Hikma’s injectables portfolio and strengthen its European and US market presence.
Cipla’s rollout of Lilly’s tirzepatide second brand comes as Wegovy price cuts tighten competition in India’s fast-growing GLP-1 market.
Teva sees olanzapine LAI as key to building a schizophrenia franchise worth up to $2bn annually, following its earlier risperidone launch.
The consolidation of Biocon-BBL is expected to unlock value, deliver operational synergies and provides BBL’s minority shareholders an 'earlier liquidity event'. Investor Viatris also signals accelerated expiration of biosimilars non-compete restrictions.
Partnership aims to improve yields, cut development time, and bring data-driven control to bioprocessing.
In the wake of recent FDA guidance setting out a streamlined approach to biosimilar registration, developers have spent the past month responding. While most reactions have been enthusiastic, some firms have sounded a note of caution.
FDA clears Accord’s first fully in-house biosimilars, with a US launch planned for its denosumab biosimilars in 2026.
Back-to-back FDA nods for generic Restasis and ProAir highlight Amneal’s growing strength in complex sterile and inhalation manufacturing.
Hot on the heels of denosumab launches by four suppliers on the first day of December, more biosimilar challengers are piling into the European market with their own rivals to Prolia and Xgeva. And the space is only going to get more crowded as further versions launch.
Four companies have confirmed launches of denosumab biosimilars in Europe, setting the stage for a competitive market for Prolia and Xgeva biosimilars.
After the recent onset of European biosimilar competition to aflibercept, the next big biologic LOE on the horizon in Europe is denosumab. Several more approvals have just arrived for rivals to Prolia and Xgeva, setting up a fiercely competitive market once biosimilars launch imminently.
Aeon’s cash infusion and upcoming FDA session, now rescheduled for early next year, positions firm to push ABP-450 biosimilar closer to market entry.
As Alvotech continues to reorganize its senior team with the promotion of chief scientific officer Joseph McClellan to chief operating officer, multiple other firms – including Hikma, Hyloris, CNX and Cingulate – have also announced executive updates.
Xbrane now expects to refile its Lucamzi biosimilar application in March 2026 after FDA manufacturing observations triggered a delay, pushing the potential approval date to September.
European Commission approval positions Celltrion to streamline hospital workflows, with modelling suggesting millions in potential annual savings for healthcare systems.
When it comes to predicting the future for generic GLP-1s, Sandoz CEO Richard Saynor believes that “everyone’s asking the wrong questions,” pointing to the importance of manufacturing capacity and ability to supply the, rather than the potential market size, as the key factor.