Biosimilars
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Biosimilars
: A biosimilar is a version of a biologic medication that is made by a different company than the one that invented it, with no clinically meaningful differences in terms of safety, potency and purity.
What Are Biosimilars?
A biosimilar is a version of a biologic medication that is made by a different company than the one that invented it, with no clinically meaningful differences in terms of safety, potency and purity.
Biosimilar Candidate to Humira® Accepted For Review | BI US
Boehringer Ingelheim announced today that its adalimumab biosimilar candidate to Humira®, has been accepted for regulatory review by the EMA and the FDA.
Cyltezo®, first and only FDA-approved Interchangeable biosimilar to Humira®, now commercially available in the U.S.
Cyltezo®, first and only FDA-approved Interchangeable biosimilar to Humira®, now commercially available in the U.S.
BI Starts Clinical Study on Interchangeability | Boehringer Ingelheim US
BI announced today that the first patient has been enrolled into its VOLTAIRE-X interchangeability study, for an adalimumab biosimilar candidate.
Cyltezo®, First Interchangeable Biosimilar to Humira®, Receives Preferred Formulary Status with Optum Rx for Commercially Insured Patients
Cyltezo®, First Interchangeable Biosimilar to Humira®, Receives Preferred Formulary Status with Optum Rx for Commercially Insured Patients
Boehringer Ingelheim Pharmaceuticals, Inc. receives FDA approval for CyltezoTM (adalimumab-adbm)
Boehringer Ingelheim Pharmaceuticals, Inc. receives FDA approval for CyltezoTM (adalimumab-adbm)
Cyltezo® (adalimumab-adbm) Patent Litigation Resolution| BI US
Read more about Boehringer Ingelheim's CYLTEZO patent litigation resolution, meaning greater access to the treatment for patients across the USA.
New agreement with Quallent expands biosimilar access
Boehringer Ingelheim enters private label agreement for biosimilar
Interchangeable Biosimilar Now on Express Scripts® Formulary
Boehringer Ingelheim’s Interchangeable biosimilar now included on Express Scripts National Preferred Formulary
Efficacy and safety maintained in patients who switched from Humira® to biosimilar Cyltezo®
Efficacy and safety maintained in patients who switched from Humira® to biosimilar Cyltezo®
Low-WAC interchangeable biosimilar is now available
Adalimumab-adbm, our interchangeable biosimilar to Humira, now available at a low wholesale acquisition cost.
Biosimilar Cyltezo® demonstrates clinical equivalence to Humira® in patients with moderate-to-severe plaque psoriasis
Biosimilar Cyltezo® demonstrates clinical equivalence to Humira® in patients with moderate-to-severe plaque psoriasis
Cyltezo® (adalimumab-adbm): First Interchangeable Biosimilar | BI US
Read more about how the FDA have approved CYLTEZO as the first interchangeable biosimilar with Humira®, supported by data from BI’s Phase III clinical trial.
Biologic Medicines & Biosimilars PDF
Interchangeable Biosimilars
Breaking-Down-Biosimilars-Infographic.pdf
Boehringer Ingelheim Statement: Favorable Ruling on Humira® Patent Challenge from U.S. Patent and Trademark Office
Boehringer Ingelheim Statement: Favorable Ruling on Humira® Patent Challenge from U.S. Patent and Trademark Office
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US FDA approves the Cyltezo® Pen, a new autoinjector option, ahead of July 1 commercial launch
US FDA approves the Cyltezo® Pen, a new autoinjector option, ahead of July 1 commercial launch
FDA approves additional formulation of biosimilar
US FDA approves additional formulation of Cyltezo® (adalimumab-adbm). See Important Safety Information including Boxed Warning, Prescribing Information, Medication Guide and Instructions for Use.
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Citizen Petition
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FDA Grants Tentative Approval for Lilly and Boehringer Ingelheim’s Basaglar™ (insulin glargine injection)
FDA Grants Tentative Approval for Lilly and Boehringer Ingelheim’s Basaglar™ (insulin glargine injection)