Approvals

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.

Back-to-back FDA nods for generic Restasis and ProAir highlight Amneal’s growing strength in complex sterile and inhalation manufacturing.

Korean firm’s Eydenzelt biosimilar win full label alignment with Eylea, including all approved ophthalmic indications.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

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.

Biological E joins the ranks of Pfizer, GSK and Serum with WHO prequalification for its pneumococcal vaccine. As WHO's purchase data for Serum’s PSV10 indicate significant opportunity, Scrip spoke to Biological E on supply readiness and its application for exemption from price control in India

The agency’s approval of Imfinzi combined with chemotherapy makes it the only immunotherapy for perioperative gastric and gastroesophageal cancers.

US FDA approval of the intrathecal formulation of Zolgensma means many more patients with spinal muscular atrophy will be eligible for the gene therapy.

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Terms like ‘game-changing’ and ‘transformational’ are regularly used by pharma companies but the data behind the latest approval for the Padcev/Keytruda combo for adults with muscle- invasive bladder cancer who are ineligible for cisplatin has been heralded by KOLs as exactly that.

Amphastar sees two highly likely launches in 2026, with one of them significantly contributing to next year's revenues. However, both generics are yet to be approved by the US FDA.