September 1, 2016 • By By Lisa Rapaport, Reuters Staff
(Reuters Health)—Many patients haven’t heard of biosimilars, generic versions of complex biotech drugs, and even some who say they’re familiar with these medicines may still be confused about them, a small European survey suggests.
To see what patients know about biosimilars, researchers analyzed data from online surveys completed by 1,181 patients with irritable bowel disease or Crohn’s disease, which are often treated with biosimilars.
Overall, just 38 percent of the survey respondents had heard of biosimilars.
An Interview With Emilio Martín-Mola
Received: 17.03.16 Accepted: 19.07.16
Citation: EMJ. 2016;1:76-84.
On January 14th 2016, SB4 (Benepali®) received marketing authorisation application approval from the European Commission (EC). It is the first biosimilar to etanercept available in Europe as well as the first subcutaneous anti-tumour necrosis factor biosimilar. Benepali® was approved for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic spondyloarthritis), and plaque psoriasis.
SB4 adds to the available biologic armamentarium of biosimilars in rheumatology, which also includes two infliximab biosimilars; one under the brand names Remsima® and Inflectra®, and the other under the brand name Flixabi®. Unlike infliximab biosimilar, which is a chimeric monoclonal antibody, SB4 is a fusion protein.
We aimed to review the current European Medicines Agency (EMA) requirements for the approval of biosimilars and how these products can integrate into daily clinical practice in rheumatology.
To that effect, we recently discussed with Dr Emilio Martín-Mola about the European framework for approval of biosimilars and the controversies that may surround this new category of medicinal products. We discussed how the advent of biosimilars in rheumatology has the potential to truly be a game-changer for both physicians and patients
August 11, 2016 • By
A recent study published online in March in the Annals of the Rheumatic Diseases investigated if the infliximab biosimilar (CT-P13, infliximab-dyyb), which is marketed in Europe as Inflectra and Remsima, can be safely and effectively substituted for infliximab (Remicade).1 Infliximab and its biosimilar are manufactured via the same process. Researchers set out to determine whether those patients with antibodies to infliximab would mount a similar response to the infliximab biosimilar (CT-P13). Two-hundred and fifty patients with rheumatoid arthritis (RA) andspondyloarthritis undergoing infliximab treatment who had never been exposed to CT-P13 were evaluated.
All patients treated with infliximab who had antibodies to infliximab cross reacted with CT-P13, either Inflectra or Remsima. The authors note that the epitopes raising the immune response to infliximab demonstrate the same degree of reactivity to the infliximab biosimilar. However, due to different glycosylation patterns or impurities, CT-P13 may possess its own unique epitopes.
July 15, 2016 • By
During the July meeting of the U.S. Food and Drug Administration’s Arthritis Advisory Committee in Silver Spring, Md., the FDA voted to approve two new biosimilars for use by rheumatologists
GP2015, a proposed biosimilar of etanercept(Enbrel), was evaluated at the FDA‘s Arthritis Advisory Committee meeting.1 The panel voted unanimously to recommend approval of GP2015.
The treatment’s proposed indications were:
- Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage and improving physical function in patients with moderate to severe active rheumatoid arthritis (RA) in combination with methotrexate (MTX) or as monotherapy;
- Reducing signs and symptoms of moderate to severe active polyarticular juvenile idiopathic arthritis in patients aged two years and older;
- Reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with psoriatic arthritis in combination with MTX in patients who do not respond adequately to MTX alone;
- Reducing signs and symptoms in patients with active ankylosing spondylitis; and
- Treating patients 18 years of age or older with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.