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Alvotech and JAMP Pharma Receive Marketing Authorization for SIMLANDI in Canada

On January 10, 2022, Alvotech Holdings S.A. (“Alvotech”) and JAMP Pharma Group (“JAMP Pharma”) announced that Health Canada granted marketing authorization to JAMP Pharma for a high-concentration biosimilar to Humira® (adalimumab) developed by Alvotech.  The biosimilar, also referred to as AVT02, will be marketed in Canada as SIMLANDI (100 mg/mL…

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British Columbia Expands Biosimilar Initiative to Rapid-Acting Insulins

On December 1, 2021 the government of British Columbia announced that it is further expanding its biosimilar initiative.  The statement reported that as of November 30, 2021 an estimated 30,000 patients on the rapid-acting insulin lispro (Humalog) and insulin aspart (NovoRapid) would have six months to transition to the respective…

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Ranibizumab Updates: FDA approval of Roche’s Refillable Ocular Implant and FDA Acceptance of Bioeq’s BQ201 BLA

On October 22, 2021 Roche announced the FDA’s approval of its ranibizumab intravitreal injection, marketed as Susvimo.  Susvimo is a refillable ocular implant—requiring refills every six months—that continuously delivers medicine into the eye for the treatment of neovascular or wet age-related macular degeneration, a condition that can cause rapid and…

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American Academy of Ophthalmology Pushes Back Against Bevacizumab Biosimilar Use in Treating Ophthalmic Conditions

On July 29, 2021, the American Academy of Ophthalmology (AAO) released a statement urging the Centers for Medicare & Medicaid Services (CMS) to prohibit Insurance companies from requiring ophthalmologists to use new biosimilar drugs as alternatives to Avastin for treatment in eye diseases.  The statement alleges that certain large healthcare…

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Study Concludes Two Adalimumab Biosimilars may be as Safe and Effective as Originator

An article published last week in Scientific Reports describes the results of a multicenter prospective study evaluating the safety and efficacy of switching IBD patients from Abbvie’s Humira product to either of two adalimumab biosimilars, ABP501 (Amgen) and SB5 (Samsung Bioepsis).  The authors concluded from this study that both biosimilars…

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Meiji Announces Promising Phase I Results for Ustekinumab Biosimilar and Initiation of Phase III Clinical Trial

On May 21, 2021, Meiji Seika Pharma Co, Ltd. announced that phase I clinical trials of DMB-3115, its proposed ustekinumab (STELARA®) biosimilar, demonstrated bioequivalence to reference products marketed in Europe and the United States.  Meiji is co-developing ustekinumab under a 2011 strategic collaboration partnership agreement with Dong-A Socio Holdings.  Phase III…

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International Biosimilar Launches: Ujvira and PrInclunox®

On May 24, 2021, Zydus Cadila launched the world’s first antibody drug conjugate (ADC) biosimilar.  The drug is a trastuzumab emtansine biosimilar—using Genentech’s Kadcyla as the reference product—that will be marketed under the name Ujvira for use in treating early and advanced HER2 positive breast cancer.  The drug is made…

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Formycon and Biocon Biologics/Viatris Share Recent Biosimilars Development News

On March 1, 2021, Formycon announced that it plans to resubmit its BLA for its Lucentis® Biosimilar Candidate FBY201 (ranibizumab) in the first half of 2021.  Formycon expects to submit its application to the EMA soon thereafter, and will also seek approval in Canada, Australia, the United Kingdom and Switzerland….

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