Big Molecule Watch

SEPTEMBER 25, 2023

Last week, FDA released a draft guidance, “ Labeling for Biosimilar and Interchangeable Biosimilar Products ” (“2023 Draft Guidance”) that—when finalized—will revise and replace its July 2018 final guidance, “ Labeling for Biosimilar Products.” The fictitious example provided in the 2023 Draft Guidance is “NEXSYMEO.”

Labelling 49

Labelling Biosimilars Adverse Reactions Dosage 49

pharmaphorum

NOVEMBER 4, 2020

Grade 3–4 adverse events occurred in 57% of people receiving Tecentriq and Avastin and 55% of people receiving sorafenib. The most frequent serious adverse reactions for the combination, occurring in 2% or more of patients, were bleeding in the gastrointestinal tract and fever.

Adverse Reactions 64

Adverse Reactions Biosimilars Immunity Immunization 64

Pharma Leaders

JUNE 15, 2023

Bradycardia, tachyarrhythmias, decreased cardiac output, ischemia, and hyponatremia are some of the adverse reactions on using Vasopressin. In addition to injectable medicines, Fresenius is engaged in developing, biosimilars, and technologies for transfusion, infusion, and clinical nutrition.

Adverse Reactions 52

Adverse Reactions Diabetes Biosimilars Hospitals 52

Pharmaceutical Business Review

JUNE 15, 2023

Bradycardia, tachyarrhythmias, decreased cardiac output, ischemia, and hyponatremia are some of the adverse reactions on using Vasopressin. In addition to injectable medicines, Fresenius is engaged in developing, biosimilars, and technologies for transfusion, infusion, and clinical nutrition.

Adverse Reactions 52

Adverse Reactions Diabetes Biosimilars Hospitals 52

FDA Law Blog: Biosimilars

MARCH 7, 2024

As a final example, current regulations require a sponsor of an investigational medical device to report to FDA (and others) “unanticipated” adverse events, which are defined in part as “serious,” and sponsors of investigational drugs to report to FDA serious and unexpected suspected adverse reactions.

Documentation 105

Documentation Adverse Reactions Communication Drug Development 105

FDA Law Blog: Biosimilars

SEPTEMBER 17, 2024

The approved labeling for UBRELVY includes a warning and precaution regarding hypersensitivity reactions, with the most common adverse reactions being nausea and somnolence. UBRELVY is indicated for the acute treatment of migraine with or without aura in adults and is not indicated for the preventive treatment of migraine.

Labelling 59

Labelling Adverse Reactions Dosage 59

FDA Law Blog: Biosimilars

JUNE 13, 2023

It has boxed warnings for hepatoxicity and QT prolongation and is contraindicated in numerous patient populations and has 17 adverse reactions with an incidence of >20%. In other words, this is a drug that requires serious risk information to be presented.

Adverse Reactions 40

Adverse Reactions 40