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Health Canada has granted NOC to Bevqolva (bevacizumab), a biosimilar version of Genentech’s Avastin
Bevacizumab, a humanized mAb, inhibits angiogenesis by blocking VEGF-A to slow tumor vascular growth in cancers like colorectal and lung. Marketed by Roche/Genentech as Avastin, it is available in 100 mg and 400 mg formulations
In 2025, Bevqolva received MHRA approval and was launched in the…
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The EC has approved Hansoh Pharmaceutical’s Aumseqa (aumolertinib mesylate tablets), marketed as Ameile in China, for use as monotx. in adult pts with advanced NSCLC with EGFR exon 19 deletions or exon 21 (L858R) mutations in the 1L therapy, and for advanced EGFR T790M mutation-positive NSCLC
Aumseqa is an oral, third-generation EGFR tyrosine kinase inhibitor (TKI) that selectively targets mutated EGFR to inhibit tumor cell growth and reduce the spread of EGFR-mutated lung cancer, while…
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FDA has approved GSK’s Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) with an eosinophilic phenotype following MHRA’s approval for both asthma & CRSwNP; regulatory review is ongoing in EU, Japan & China
Approval was based on the P-III trials: SWIFT-1 (n=382) & SWIFT-2 (n=380) assessing Exdensur vs PBO, both in addition to SoC,…
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Klinge Pharma, holder of global commercialization rights for Formycon’s FYB203, has entered into an exclusive agreement with NTC to commercialize FYB203, a biosimilar version of Eylea (aflibercept), in Italy
As per the deal, Klinge will receive royalties on net sales, with Formycon participating in these payments in the mid-single to low-double-digit % range, while…
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The EC has approved Brinsupri (25mg) for treating NCFB pts (≥12yrs.), with ≥2 exacerbations in the prior 12mos. under EMA'saccelerated assessment pathway; Application is under PMDA & MHRA review, & Insmed is planning to work with EU authorities to enable patient access starting in early 2026
Approval was based on extensive clinical data, incl. P-III (ASPEN)…
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The US FDA has accepted the resubmitted BLA of ONS-5010 (bevacizumab-vikg) for the treatment of wAMD, considering a Class 1 review & granting a PDUFA goal date Dec 31, 2025; if approved, it will be branded Lytenava
ONS-5010 (intravitreal) is an ophthalmic bevacizumab formulation that binds all VEGF isoforms to block VEGF interaction with…
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The UK’s MHRA has approved Leqembi (IV, Q4W) as a maintenance therapy for early Alzheimer’s pts after completing 18mos. of Q2W Leqembi treatment
Leqembi is approved in 51 countries for early AD & under review in 9, while the Q4W maintenance is approved in the UK, China, the US, & others, with 4 applications…
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The UK’s MHRA has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, axial spondylarthritis & ulcerative colitis in adult pts & juvenile idiopathic arthritis, following CHMP’s positive opinion
Additionally, Alvotech is responsible for the development & commercial supply of Gobivaz, while…
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The UK’s MHRA has approved Xoanacyl (ferric citrate complex) for the treatment of concomitant elevated serum phosphorus & iron deficiency in CKD adults via International Recognition Procedure (Route B), following EC’s approval in Jun 2025
In Dec 2022, Averoa obtained an exclusive license from Akebia Therapeutics to develop & commercialize Xoanacyl in the EEA,…
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The UK’s MHRA has accepted a conditional marketing authorization (CMA) application for Tinlarebant to treat Stargardt disease
CMA was based on the interim results from P-III (DRAGON) trial assessing Tinlarebant vs PBO in 104 adolescents with Stargardt disease across 11 jurisdictions, incl. the US, UK, Germany, France, Belgium, Switzerland, Netherlands, China, Hong Kong, Taiwan,…

