Biosimilar Development News
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Henlius And SVAX Forge Strategic Partnership In The MENAT Market
11/8/2024
On the morning of November 7, at the 7th China International Import Expo (CIIE), Henlius (2696.HK) entered into a strategic collaboration with AL-TIRYAQ AL-KHALAWI Medical Company ("SVAX"), a subsidiary entity of Saudi Arabia's prominent family business group in the healthcare sector, the Fakeeh Family.
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MilliporeSigma Invests $76 Million To Expand ADC Manufacturing For Novel Cancer Therapies
11/6/2024
MilliporeSigma, the U.S. and Canada Life Science business of Merck KGaA, Darmstadt, Germany, today announced a $76 million expansion of its ADC manufacturing capabilities and capacity at its Bioconjugation Center of Excellence facility in St. Louis, Missouri. This investment will triple existing capacity and enhance the company’s contract development and manufacturing organization (CDMO) offering, reinforcing its commitment to clients and patients.
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European Medicines Agency Confirms Acceptance Of Marketing Authorization Application For AvT05, A Proposed Biosimilar To Simponi® (golimumab)
11/4/2024
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Advanz Pharma, a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT05, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases.
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Meitheal Pharmaceuticals Secures Exclusive Commercial Licensing Agreement For Three Biosimilars In The U.S.
10/31/2024
Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, today announced it has expanded its biosimilars portfolio with an exclusive commercial licensing agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd. (“HKF”) to market and distribute three biosimilars in the U.S. The agreement covers biosimilars for oncology medications pegfilgrastim and filgrastim as well as follitropin alpha in the fertility space.
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US FDA Accepts Biologics License Application (BLA) For HLX14, Biosimilar Candidate Of PROLIA/XGEVA (denosumab)
10/30/2024
Shanghai Henlius Biotech, Inc. and Organon announced that the US Food and Drug Administration (FDA) has accepted the Biologic License Application (BLA) for HLX14, an investigational biosimilar of PROLIA/XGEVA (denosumab).
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CMS Grants Fresenius Kabi Permanent, Product-Specific Q-Code And Pass-Through Payment Status For Tyenne (tocilizumab-aazg)
10/29/2024
Fresenius Kabi, an operating company of Fresenius, announced today that the Centers for Medicare and Medicaid Services (CMS) issued a permanent, product-specific billing code and granted pass-through payment status for Tyenne (tocilizumab-aazg).
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AscellaHealth Releases Q3 2024 Specialty & Rare Pipeline Digest™: FDA-Approved Biosimilars Outpaces Cell And Gene Therapy Amid Complex Regulatory Challenges
10/22/2024
AscellaHealth, a global partner delivering customizable solutions to support the specialty pharmaceutical industry, today released its latest Specialty & Rare Pipeline Digest™, the industry’s most comprehensive digital resource of new, pending and upcoming specialty and rare disease drug launches, cell and gene therapies (CGTs) and biosimilars.
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Alvotech And Teva Announce U.S. FDA Approval Of Additional Presentation Of SELARSDI™ (ustekinumab-aekn), Expanding Its Label To Include Further Indications Approved For Reference Product, Stelara® (ustekinumab)
10/22/2024
Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) in a new presentation, 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion.
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CHMP Recommends The Approval Of Dong-A ST's IMULDOSA, A Biosimilar To Stelara
10/21/2024
Dong-A ST announced on October 18th that its biosimilar IMULDOSA (active ingredient: ustekinumab, development code DMB-3115), referencing Stelara, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA).
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Boan Reports Positive PK Similarity Study Results Of BA1104
10/21/2024
The phase I clinical study aimed to establish the pharmacokinetic (PK) similarity between Boan Biotech’s Nivolumab injection BA1104(previously code-named LY01015)and Opdivo was recently published online in BioDrugs.