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NEWS

Samsung Bioepis Expands Partnership with Teva to Advance Up to 6 Biosimilar Candidates

Shots: Samsung Bioepis & Teva have expanded their strategic partnership to advance up to ~6 biosimilar candidates, incl. SB41, a biosimilar version of Fasenra (benralizumab), & SB44, a biosimilar to Ilaris (canakinumab) As per the deal, Samsung Bioepis will develop, manufacture & handle regulatory registration of the biosimilars, while Teva will lead commercialization in the…
October 5, 2026

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Meitheal Pharmaceuticals
NEWS

Meitheal Pharmaceuticals Reports US FDA Approval of High-Concentration Formulation of Yusimry (Biosimilar, Humira)

Shots The US FDA has approved a citrate-free, high-concentration formulation for Yusimry as an interchangeable biosimilar to Humira (adalimumab) Yusimry, a TNF blocker, is available in low and high concentration formulations via autoinjector, with the low-concentration formulation also available as a PFS Emerge Bioscience holds the approved BLA for Yusimry, while Meitheal serves as its…
September 30, 2026

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NEWS

STADA and Sino Biopharmaceutical Partner to Advance Biosimilar Access   

Shots:  STADA and Sino Biopharmaceutical, through its subsidiary CTTQ, have entered into a strategic biosimilar partnership designed to broaden patient access to biological medicines in key markets  As per the deal, CTTQ will develop, manufacture & supply the biosimilar candidates, while STADA will hold marketing authorizations and exclusive sales & marketing rights in the EU,…
September 28, 2026

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NEWS

mAbxience and Sandoz Partner to Advance Emicizumab Biosimilar Access Globally

Shots: mAbxience & Sandoz have entered into a licensing, development, manufacturing & commercialization agreement for an emicizumab biosimilar candidate As pe the deal, mAbxience will develop & manufacture the biosimilar at its GMP-approved facilities in Spain & Argentina, while Sandoz will hold exclusive global commercialization rights (excl. Argentina, Uruguay & Paraguay); financial terms remain confidential…
September 21, 2026

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NEWS

Henlius Reports NMPA NDA Acceptance of 120mg (1.7mL) per Vial Strength of HLX14 (Biosimilar, Denosumab) 

Shots:  The NMPA has accepted NDA for HLX14, a biosimilar version of denosumab, in the 120mg (1.7mL) per vial strength presentation    NDA was based on extensive data, incl. analytical similarity studies, non-clinical & clinical comparative studies, where HLX14 at the 120 mg (1.7 mL) per vial strength showed similarity to its reference drug in terms…
September 11, 2026

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Samsung Bioepis
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Samsung Bioepis Reports MHLW Approval of its Ustekinumab Biosimilar

Shots: The MHLW has granted marketing approval to Ustekinumab BS IV infusion 130mg 「NIPRO」, a biosimilar version of Stelara (ustekinumab), for induction therapy in mod. to sev. active Crohn’s disease when other treatments are ineffective Additionally, the MHLW approved Ustekinumab BS SC Injection 45mg Syringes 「NIPRO」in Dec 2025, which was then launched in May 2026  The biosimilar…
September 4, 2026

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NEWS

Cipla Partners with Qilu Pharmaceutical to Commercialize QL2107 (Biosimilar, Keytruda) in the US

Shots: Invagen Pharmaceuticals, a wholly owned subsidiary of Cipla, has entered into a strategic partnership with Qilu Pharmaceutical for the exclusive licensing & supply of QL2107, a biosimilar version of Keytruda (pembrolizumab), for the US As per the deal, Qilu will handle product development, regulatory registration & supply, while Cipla USA will commercialize the asset across the…
September 4, 2026

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