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Driven by innovation and a steadfast commitment to advancing cutting-edge therapies, the biopharma industry experienced robust growth in 2024, marked by significant revenue milestones
With a projected compound annual growth rate (CAGR) of 12.87%, the global biopharma market is expected to reach $1.41 trillion by 2032. In 2024, Pfizer led the industry with total…
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Intas has acquired Coherus’ Udenyca business (incl. prefilled syringe, autoinjector & on-body injector), a biosimilar version of Amgen’s Neulasta (pegfilgrastim) via 2024 asset purchase agreement; Accord BioPharma (Intas’ US specialty division) will handle Udenyca’s US business
As per the deal, Coherus received $483.4M upfront in cash, incl. $118.4M for Udenyca inventory, with an additional…
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Amgen has reported P-III (DeLLphi-304) trial data evaluating Imdelltra (tarlatamab-dlle) vs SoC CT (topotecan globally excl. Japan; lurbinectedin in the US, Canada, Australia, Singapore, Korea; & amrubicin in Japan) in SCLC pts who progressed on or after single line of Pt-based CT
In the interim analysis, trial met its 1EP, with superior OS; full…
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The US FDA has approved Uplizna to treat adults with IgG4-RD; regulatory filings for gMG are underway, with completion expected in H1’25
Approval was based on P-III (MITIGATE) trial assessing Uplizna (n=68) vs PBO (n=67) in IgG4-RD adults, which incl. an optional 3yr. OLE & up to 2yrs. of safety follow-up after Uplinza discontinuation
Trial…
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The CHMP has recommended Osvyrti & Jubereq, biosimilar versions of Amgen’s Prolia & Xgeva (denosumab); launch expected post patent expiry of reference products in Nov 2025
Osvyrti (60mg pre-filled syringe) is indicated to treat osteoporosis in postmenopausal women & men at increased risk of fractures. It also used to treat bone loss in pts…
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The US FDA has approved BLA of Conexxence & Bomyntra, biosimilar versions of Prolia & Xgeva (denosumab) for all indications of the reference products
Approval was supported by extensive analytical development & similarity assessment based on 2 trials: one assessing its PK, PD, & immunogenicity in healthy volunteers, & other evaluating its efficacy, PD, safety,…
Alvotech and Dr. Reddy’s Report the US FDA’s BLA Acceptance for AVT03 (Biosimilar, Prolia and Xgeva)
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The US FDA has accepted 351(k) BLA of AVT03, a biosimilar version of Prolia & Xgeva (denosumab), for all indications of reference product
As per the 2024 license & supply agreement, Alvotech is responsible for the development & manufacturing of AVT03, while Dr. Reddy’s handles registration & marketing in licensed regions, incl. the U.S. …
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Amgen has reported P-III (MINT) trial data on Uplizna vs PBO in adults (N=238) with AChR+ gMG (n=190) or MuSK+ gMG (n=48), followed for 52 & 28wks., respectively; sBLA under FDA’s priority review for IgG4-RD (PDUFA: Apr 3, 2025), with regulatory filings expected to end by H1’25
Pts received an initial loading dose…
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The EC has approved Blincyto monotherapy as a part of consolidation therapy to treat 1L philadelphia chromosome-negative CD19+ B-ALL adults based on P-III (E1910) trial
Blincyto + CT showed improved OS with 4.5yrs. median follow up vs CT alone, whereas 5-yrs. mFU demonstrated 82.4% vs 62.5% OS in 112 pts
The trial was led by…
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The FDA has approved Lumakras + Vectibix combination to treat metastatic KRAS G12C-mCRC in adults diagnosed via FDA approved test, receiving fluoropyrimidine-, oxaliplatin- & irinotecan-based CT
The approval was based on P-III (CodeBreaK 300) Trial assessing Lumakras (960mg/240mg, QD) + Vectibix vs investigator’s choice of SoC (n=54; trifluridine/tipiracil or regorafenib) in patients
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