Biosimilars
The European Commission’s pending decision for Stada-Bio-Thera could bring a second golimumab biosimilar to market, tightening competition behind Alvotech-Advanz’s early launch plans.
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.
Responding to the newly-agreed EU pharma package, Medicines for Europe said the deal was a limited political compromise that could have been more ambitious – particularly when it comes to access – but nevertheless represented “an important step forward” and “progress” for the EU pharma sector.
Formycon has again stepped closer to financial certainty with another pembrolizumab biosimilar deal. This time, it unlocked a significant opportunity for the US and Canadian markets.
The Belgian Competition Authority has confirmed that it is escalating a complaint against Roche over alleged strategies used to delay biosimilar competition to rituximab and trastuzumab.
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.
Collaboration aims to bring two biosimilars for osteoporosis and osteoarthritis to Mexico, with Saya leading commercialization and Enzene overseeing development and manufacturing.
While the long-awaited pembrolizumab biosimilar deal certainly boosts Formycon’s financials, it is unclear whether it will be enough to meet its annual guidance.
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.
Lupin announced US FDA approval for its Armlupeg (pegfilgrastim-unne) biosimilar and a licensing deal with Valorum in a span of a few days.
FDA clears Accord’s first fully in-house biosimilars, with a US launch planned for its denosumab biosimilars in 2026.
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.
Korean firm’s Eydenzelt biosimilar win full label alignment with Eylea, including all approved ophthalmic indications.
In an exclusive interview, Generics Bulletin spoke to a trio of experts who argue that biosimilar cell and gene therapies are technically within reach but demand unprecedented regulatory clarity, manufacturing evolution and economic alignment before they become reality.
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.
Prestige Biopharma has picked Biosidus to manufacture and export its Tuznue biosimilar rival to Herceptin across four Latin American countries.