Deans' stroke musings

Changing stroke rehab and research worldwide now.Time is Brain!Just think of all the trillions and trillions of neurons that DIE each day because there are NO effective hyperacute therapies besides tPA(only 12% effective). I have 493 posts on hyperacute therapy, enough for researchers to spend decades proving them out. These are my personal ideas and blog on stroke rehabilitation and stroke research. Do not attempt any of these without checking with your medical provider. Unless you join me in agitating, when you need these therapies they won't be there.

What this blog is for:

Shortly after getting out of the hospital and getting NO information on the process or protocols of stroke rehabilitation and recovery I started searching on the internet and found that no other survivor received useful information. This is an attempt to cover all stroke rehabilitation information that should be readily available to survivors so they can talk with informed knowledge to their medical staff. It's quite disgusting that this information is not available from every stroke association and doctors group.
My back ground story is here:

Friday, September 2, 2016

FDA Approves Etanercept Biosimilar

You will notice nothing here on uses for stroke. There wouldn't be, Dr. Tobinick(19 posts) seems to have never even entertained trying to get his uses of etanercept tested in a clinical trial.
Curious about etanercept? I've written 27 posts on it.
The FDA today approved Erelzi, a biosimilar to etanercept (Enbrel), for all the indications included in the labeling of the reference product, according to manufacturer Sandoz.
The injectable medication can be used for these conditions:
  • Moderate to severe rheumatoid arthritis, alone or in combination with methotrexate
  • Moderate to severe polyarticular juvenile idiopathic arthritis in patients ages 2 years and older
  • Active psoriatic arthritis, including as a combination therapy with methotrexate for patients with an inadequate response to methotrexate monotherapy
  • Active ankylosing spondylitis
  • Moderate to severe plaque psoriasis in adults
In its separate news release, the FDA advised healthcare professionals to review the biosimilar product's prescribing information for details about its use. Included are the same boxed warnings about risks of serious infections and certain hematologic malignancies also carried on etanercept's label.
"The biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases," Janet Woodcock, MD, director of the agency's Center for Drug Evaluation and Research, said in the news release.
"We carefully evaluate the structural and functional characteristics of these complex molecules. Patients and providers can have confidence that there are no clinically meaningful differences in safety and efficacy from the reference product," she said.
In July, the FDA Arthritis Advisory Committee unanimously recommended approval of the biosimilar. It had been evaluated in four pharmacokinetic studies that included 216 healthy volunteers and in a clinical study of 531 patients with chronic plaque psoriasis that confirmed "efficacy and safety similarity."
Pharmacodynamic and immunogenicity data also were reviewed during the approval process.
The FDA also stated that Erelzi is a biosimilar, not an interchangeable product. The designation of interchangeable indicates that it's safe to switch between the reference and biosimilar products.
A biosimilar to infliximab (Remicade) known as Inflectra, also has been approved, but has faced difficulties in reaching the marketplace because of patent disputes. In addition, a biosimilar to adalimumab (Humira) has demonstrated clinical equivalence in a phase III study.
An application for the biosimilar also is under review by the European Medicines Agency.
Sandoz is a Novartis company.

No comments:

Post a Comment