Biogen announced that the European Union approved Flixabi, their second anti-TNF biosimilar drug therapy in the European market. Samsung Bioepis developed Flixabi with a joint venture with Biogen and Samsung Biologics.
The European Commission granted the marketing authorization of Flixabi – an infliximab replica drug of Remicade. Flixabi is an anti-TNF used for adult patient suffering from rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, Chrons disease and ulcerative colitis. This biosimilar drug can also be used by 6 to 17 years old having an active and severe form of Chron’s Disease or severe active Ulcerative colitis.
Flixabi is the second anti-TNF replica drug to be produced and commercialized by Biogen in the European Union. Early this year, their conglomerate, Samsung Bioepis received an approval for marketing Benepali with the generic name etanercept which is a biosimilar drug of Enbrel, an anti-TNF therapy.
Since then, Benepali was lunched all over Europe. It is estimated that anti-TNF therapies earns $10 Billion a year in the European market. In fact, this is the largest market for anti-TNF therapy. Flixabi and Benepali will provide the patients and their physician an alternative treatment that will save them a huge amount of medical expenditures.
Flixabi’s approval marks Samsung Bioepis and Biogens step to move forward in the field of biopharmaceutical industry. Alpna Seth, PhD, Global Head of the Biosimilars Unit and Senior Vice President of Biogen shared that Flixabi is an addition to their anti-TNF portfolios. It also proves Biogens commitment in providing advanced biosimilar drugs to expand cost-effective treatment options for patients suffering chronic inflammatory diseases like ulcerative colitis and Chron’s disease. They are also proud to announce that they are the first company to commercialize two anti-TNF biosimilar therapy drugs to patients and physicians in Europe.
Founded in 1978, Biogen is one of the oldest and independent biotechnology companies in the world. It discovers, produce and deliver innovative therapy for people living with serious autoimmune, neurological, and rare diseases. The company offers the leading therapies in multiple sclerosis and innovative therapy for hemophilia.
Robust Clinical Data
In their application, Samsung Bioepis, submitted a comprehensive preclinical and clinical data package presenting a head-to-head Phase 1 and Phase 3 clinical trials. They compared Flixabi with Remicade, the reference product.
With the European Medicines Agency biosimilar approval guidelines, Flixabi’s phase 3 clinical trials were performed to confirm its equivalent efficacy, immunogenicity, and safety, with the reference drug. The phase 3 clinical trial was conducted for 54 weeks using a double-blind study. The patients enrolled in the clinical trial are those who have moderate to severe Rheumatoid arthritis taking methotrexate therapy.
The final end point of the study was with the American College of Rheumatology 20% (ACR20) response on their 30 week pre-protocol set (PPS). The clinical trial was able to provide a data showing that patients taking Flixabi had equivalent ACR20 response. They were able to prove that Flixabi has a comparable safety profile with Remicade.
The Era of Biosimilar Drugs
The high medical costs have prompted the patients and their physicians to look for alternative drugs that would provide the same effect but in a much lower price. Biosimilar drugs are the key to a more affordable medicine which will benefit the low and middle income families.
In the years to come, it is expected that expensive drugs which has recently lost their patency will now have its replica drug. This will not only provide affordable medicines but will also improve the survival rate of the affected patient because they have more access to reasonably priced medicines.
This era will also pushed larger companies to provide of innovative drugs that will give them patency for a certain period of years. In this way, they can still own a specific market. Or this may pushed them to lower their prices or produced a more improved drug so they can compete with biosimilar drugs.