biologic drugs

A noteworthy margin of error in psoriasis?Dermatologists need to be aware of margin of error and related issues that can affect the results of biosimilar clinical trials, a study shows.
European Commission approves adalimumab for paediatric uveitisThe European Commission has approved adalimumab (Humira, AbbVie) as the first biologic treatment for chronic non-infectious anterior uveitis in paediatric patients from 2 years of age who have had an inadequate response to conventional therapy.
NICE recommends dexamethasone adalimumab for uveitisThe UK’s National Institute for Health and Care Excellence (NICE) has given preliminary approval to dexamethasone 0.7 mg intravitreal implant (Ozurdex, Allergan) and adalimumab (Humira, AbbVie) for sight-threatening non-infectious posterior uveitis.
Pearls to optimize safety, success with biologicsOne dermatologist describes his considerations for choosing a biologic to treat a patient with moderate-to-severe psoriasis, baseline assessments, and follow-up approach.
The biosimilar balance: More options, lower costsThe fly in the ointment: CMS' current plan for HCPCS codes is a real buzz kill.
Can you maintain response after biologic holiday?Melinda Gooderham, M.D., MSc, FRCPC Patients might stop taking their biologic medications for a variety of reasons. When patients do stop their biologic therapy, clinicians need to consider that some biologic therapies are better at recapturing response than others. learn more
Practice gapsDermatologists often must weigh their desire for definitive data with the realities of caring for individual patients.
FDA issues biosimilar final guidanceFDA has issued 3 final biosimilar guidances for industry: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.
[BLOG]: FDA approves first biosimilar in US, may lead to easier access to biologic medications for patientsIn this guest blog post, Larry LaMotte, spokesperson for Patients for Biologics Safety & Access and Vice President of Public Policy at the Immune Deficiency Foundation, discusses the possibility of biosimilars helping increase access to vital medications for patients with chronic and life-threatening conditions.
Infection risk from biologics deserves careful scrutinyPatients with risk factors such as older age and chronic lung or renal disease must be highly vigilant for serious infections while on biologic drugs, an expert says.