All posts related to "biosimilar"

Let BC PharmaCare hear “Your Voice” on biosimilar etanercept

Stickman with megaphone calling for patient inputBC PharmaCare is looking for your input on biosimilar etanercept (Erelzi) for the treatment of ankylosing spondylitis, juvenile idiopathic arthritis and rheumatoid arthritis

Biosimilar etanercept (Erelzi) is now being considered for coverage under the British Columbia Ministry of Health’s PharmaCare program. By filling out a questionnaire on a website called Your Voice, you can provide your input on biosimilar etanercept for the treatment of ankylosing spondylitis (AS), juvenile idiopathic arthritis (JIA) and rheumatoid arthritis (RA). You can give input if you are a B.C. resident and have AS, JIA or RA, a caregiver to someone with AS, JIA or RA, or if your group represents people who live with AS, JIA or RA.
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Health Canada approves biosimilar etanercept for RA and AS

Approved stampHealth Canada approves biosimilar etanercept for rheumatoid arthritis and ankylosing spondylitis

What does this mean for patients?  

On August 31, 2016, the biosimilar etanercept (BRENZYS) was approved for the treatment of rheumatoid arthritis and ankylosing spondylitis.

BRENZYS is a subsequent entry biologic (biosimilar) to the Canadian authorized reference product, Enbrel. Both contain the active pharmaceutical ingredient, etanercept. Continue reading

JointHealth™ insight – septembre 2016

Près d’un Canadien sur cinq souffre d’arthrite. Alors qu’attendons-nous pour lancer un mouvement social ?

JHI Biosimilar FR banner

Dans ce numéro du JointHealth™ insight :

Au cours d’un récent dîner, un bon ami à moi me confiait quelque chose d’assez révélateur : « Je ne te considère pas comme handicapée ».

Pour lui, son commentaire était plutôt un compliment. Mais pour moi, il illustre l’ampleur de cette fausse perception très répandue à propos de la douleur arthritique comme étant un « état » associé au vieillissement et qu’on ne peut pas vraiment traiter. Son commentaire m’a également rappelé à quel point les personnes atteintes d’arthrite, souvent embarrassées à propos de leur maladie, vivent la douleur arthritique en silence, et cela, en dépit du fait que l’arthrite, une maladie invalidante et la cause principale de l’incapacité de travail au Canada, affecte plus de 4,6 millions de Canadiennes et de Canadiens et restreint de près de 20 pour cent les activités de nos concitoyens.

Dans ce numéro du JointHealth™ insight, vous trouverez également :

  • Meilleur milieu de travail au Canada pour les employes atteints d’arthrite
  • Biosim•Exchange :
    première plateforme d’information au Canada sur les biosimilaires

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JointHealth™ insight – September 2016

Roughly one in five Canadians live with arthritis. Where is our social movement?

JHI September 2016 Slide ImageCheryl Koehn, Founder and President of Arthritis Consumer Experts (ACE) wants to start a movement for arthritis. In this issue of JointHealth™ insight, she comments about the myth of arthritis:

At a recent dinner party, a good friend of mine said something revealing to me: “I don’t think of you as disabled.” My friend’s comment was meant as a compliment but also reflected the still common misperception of arthritis pain as a “condition” associated with getting old and that can’t really be treated. It also reminded me how people with arthritis are often embarrassed about it and live in silence. This in spite of the fact that arthritis affects more than 4.6 million Canadians, is a debilitating disease and the leading cause of work disability in Canada and limits the activities of nearly 20% of Canadians.

To celebrate Arthritis Awareness Month in Canada, this issue of JointHealth™ insight will also highlight two of ACE’s programs:

  • Canada’s Best Workplaces for Employees Living with Arthritis Award
    This year’s program will recognize workplaces who provide an environment that meets the needs of employees living with arthritis to manage their disease and work with symptoms such as pain, fatigue, joint dysfunction or immobility
  • Biosim•Exchange
    A reader-friendly information hub for consumers and health care professionals to get the latest biosimilars news.

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Let BC PharmaCare hear “Your Voice” on etanercept SEB

Stick man holding megaphoneBC PharmaCare is looking for your input on etanercept SEB for the treatment of rheumatoid arthritis and ankylosing spondylitis

Etanercept SEB is a subsequent entry biologic version of etanercept (Enbrel). Etanercept SEB is used for treating people with moderate to severe rheumatoid arthritis (RA) and ankylosing spondylitis (AS) and works by targeting the tumor necrosis factor alpha (TNFA) molecule. It is given by subcutaneous injection.

A SEB needs to have the same mechanism of action as the originator biologic it was compared to, which means it should work in a similar way. Health Canada defines SEBs as a “biologic drug that enters the market subsequent to a version previously authorized in Canada, and with demonstrated similarity to a reference biologic drug.” Continue reading

FDA proposed new naming policies for biosimilar drugs for RA

Yellow and Purple pills in palm of handThe Food and Drug Administration (FDA) has proposed new naming policies for the distinct naming of biosimilars and biologics for rheumatoid arthritis treatment. The new draft guidance is called Nonproprietary Naming of Biological Products: Guidance for Industry and is available to view here.

Under the new policies, which will be designated and enforced by the FDA, separate and distinctive names will be required when it comes to biosimilars and biologic drugs. This will ensure that pharmaceutical companies are following regulations and will remain compliant when it comes to the naming and marketing of biosimilar medications.  Continue reading