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Scientific Research Biosimilars

Goodwin

FDA Announces Biosimilar Funding Opportunity

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On March 7, 2022, the US Food and Drug Administration (FDA) issued a Funding Opportunity Announcement (FOA) to commit up to $5 million in fiscal year 2022 toward several research proposals. Specifically, the FDA anticipates...more

Smart & Biggar

New reports on utilization of biologics and biosimilars for chronic inflammatory diseases in Ontario

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The Canadian Agency for Drugs and Technologies in Health (CADTH) has released a report titled Utilization of Innovator Biologics and Biosimilars for Chronic Inflammatory Diseases in Canada: A Provincial Perspective. The...more

Goodwin

Researchers Publish Results Of Biosimilar-Switching Studies

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In 2017, the Health Department of Brazil’s Federal District ordered that patients currently prescribed Remicade (infliximab) be switched over to the biosimilar, Remsima.  Earlier this month, researchers in Brazil published a...more

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Study Shows that Celltrion’s Infliximab Biosimilar is Comparable to Reference Infliximab and Adalimumab

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According to a Celltrion press release, this week investigators presented twelve-month data from a UK-wide, three-year prospective observational study showing comparable efficacy between CT-P13 (Celltrion’s biosimilar...more

Goodwin

Update on Biosimilar Testing: Cinfa, Mylan/Biocon, Sandoz

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Below is a roundup of several recently published comparative studies between biosimilars and reference biologics. In a study presented at the American Society of Hematology’s 59th Annual meeting, the authors concluded that...more

Goodwin

Boehringer Ingelheim Announces Interim Results on Adalimumab Biosimilar Candidate BI695501

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Today, Boehringer Ingelheim announced the 24-week results from the Phase III VOLTAIRE®-RA study, comparing the adalimumab biosimilar candidate BI 695501 to Abbvie’s Humira® in patients with moderate- to severely-active...more

Goodwin

Boehringer Ingelheim Announces Positive Phase III Results For Its Humira Biosimilar Candidate

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Last week, Boehringer Ingelheim announced that BI 695501, a proposed biosimilar of Humira (adalimumab), met the primary efficacy endpoint in a pivotal Phase III study comparing BI 695501 to Humira for treatment of patients...more

Goodwin

Norwegian Study Concludes Infliximab Biosimilar Not Inferior To Remicade

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A study conducted by the Norwegian government compared Johnson & Johnson’s Remicade (infliximab) to Celltrion’s approved biosimilar Remsima. The “NOR-SWITCH” study, which cost $2.5 million, was a 52-week Phase IV study that...more

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JHU: Preliminary Evidence Supports Similarity of TNF-alpha Biosimilars To Reference Products

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In a study published on August 2nd, a team of scientists from Johns Hopkins Bloomberg School of Public Health in Maryland and Brigham and Women’s Hospital in Massachusetts conclude that preliminary evidence shows an...more

McGuireWoods LLP

IGPA 2015 Focuses on Biosimilars, Quality, and Harmonization in Toronto-Part Two of Two

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The following day features a panel of chief executive officers from a variety of pharmaceutical companies of different sizes and focus areas. Common themes included ongoing industry consolidation and increasing concern about...more

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