March 20th 2023
At the American Academy of Dermatology annual meeting, Samsung Bioepis shared positive results from a phase 1 study comparing its ustekinumab biosimilars (SB17) with the reference product (Stealara).
Study: Does Adalimumab Lose Effectiveness After Switching to a Biosimilar?January 7th 2023
The authors of an retrospective real-world study of patients with hidradenitis suppurativa treated with adalimumab concluded that switching patients between adalimumab products risked a greater likelihood of loss of effectiveness.
Nova Scotia Becomes Fifth Canadian Province to Implement a Biosimilar Switching ProgramFebruary 5th 2022
The province is the latest jurisdiction to adopt a program that will require patients to switch away from expensive reference biologics to select biosimilars for certain conditions.
Opinion: FDA Changes to Biosimilar Development Guideline Save Money and TimeSeptember 11th 2021
Refinements to the analytical testing of biosimilar candidates to verify similarity were worked into 2019 guidance from the FDA. These changes offer what the author considers a more "rational approach."
BIO Attorneys Address Patent Thicket MisconceptionsSeptember 8th 2021
In this first part of a series, intellectual property attorneys from the Biotechnology Innovation Organization (BIO) contend that originator patents are not the formidable obstacles to biosimilars they are made out to be.
Opinion: The Debate Over Animal Toxicology StudiesSeptember 4th 2021
Animal toxicology studies still get included with biosimilar approval applications, although there are strong arguments that most of these studies are unnecessary. Sarfaraz K. Niazi, PhD, explains the pros and cons.
IPC Guidance Is Issued on Safety of Biosimilar Switching in PsoriasisAugust 25th 2021
The International Psoriasis Council (IPC) reaches consensus on switching, patient agreement, and biosimilar safety and efficacy qualification. The IPC guidance is conservative when it comes to substitution of these products.
Pharmacy Economist Describes Fork in the Road for Generics and BiosimilarsJune 1st 2021
Biosimilar manufacturers may encounter roadblocks in the months and years ahead, and generics manufacturers will find they've hit a ceiling, according to Adam Fein, PhD, CEO of the Drug Channels Institute.