JD Supra

FDA Releases Draft Guidance on Evaluation of Therapeutic Equivalence of Approved Biologic and Small Molecule Drugs

On July 20th, the FDA released draft Guidance regarding its standards on therapeutic equivalence (TE) between both biologic and small molecule (NCE) drugs. The definition of "therapeutic equivalence" ...
JD Supra

FDA to consider patent listing, therapeutic equivalence, and other Orange Book issues; agency will issue draft guidance documents, seek public comment

FDA Commissioner Scott Gottlieb, M.D. recently announced four steps FDA will be taking to ensure that the Orange Book (FDA’s publication of Approved Drug Products with Therapeutic Equivalence ...
Nasdaq

Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT04 and Reference Product Stelara®

The confirmatory clinical, safety and efficacy study for AVT04, biosimilar candidate to Stelara® (ustekinumab) met its primary endpoint AVT04 (ustekinumab) is part of a broader pipeline of Alvotech’s ...
Healio

Proposed biosimilar shows equivalence to golimumab in rheumatoid arthritis

Please provide your email address to receive an email when new articles are posted on . Alvotech’s AVT05 showed therapeutic equivalence with golimumab in DAS28-CRP score change at 16 weeks. The ...
Nasdaq

Pfenex Reports Positive Results for PF708 Comparative Use Human Factors Study

Study results found that the FDA-approved PF708 product is noninferior to Forteo® based on a pre-specified statistical analysis of critical patient and caregiver tasks Pfenex believes the study report ...
Business Wire

Dong-A ST Demonstrates Therapeutic Equivalence Between DMB-3115 and Stelara in Global Phase III

SEOUL, South Korea--(BUSINESS WIRE)--Dong-A ST (President and CEO: Min-young Kim) (KRX:170900) announced on January 16th that therapeutic equivalence and safety were established between DMB-3115 and ...
Becker's Hospital Review

FDA raises safety issue in generic organ anti-rejection drug

The FDA reduced its therapeutic equivalence rating in Accord Healthcare’s tacrolimus oral capsules because of safety concerns, but the generic’s approval remains, the agency said Sept. 19. Tacrolimus ...
Monthly Prescribing Reference

Accord Healthcare’s Tacrolimus Oral Capsules No Longer Substitutable for Prograf

Credit: FDA. The BX rating indicates that the data are insufficient to show that the product provides the same therapeutic effect as Prograf. The Food and Drug Administration (FDA) has changed the ...
Medscape

FDA Moves Generic Dapagliflozin a Step Closer to US Sales

The US Food and Drug Administration (FDA), on February 23, finalized its decision approving the therapeutic equivalence of a generic formulation of the SGLT2 inhibitor dapagliflozin made by Zydus ...
Business Wire

Alvotech Clinical Study Results Demonstrate Therapeutic Equivalence between Biosimilar Candidate AVT04 and Reference Product Stelara

REYKJAVIK, Iceland--(BUSINESS WIRE)--Alvotech Holdings S.A. (“Alvotech”), a global biotech company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, ...