Spondylitis News and Research

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Researchers explore benefits and risks of biosimilar antibodies

In the emerging biosimilar market, biosimilar antibodies are being developed to treat conditions currently addressed by their original, targeted biological therapy. Only a few biosimilars are approved by the EMA, and just one has been approved by the FDA. In a review article, researchers used the clinical development data from one drug to explore the broader benefits and risks of these cost-effective, but as yet unfamiliar treatment options.

17 Apr 2015

Hospira announces availability of INFLECTRA (infliximab) in Canada

Hospira, Inc., a global leader in biosimilars and the world's leading provider of injectable drugs and infusion technologies, announces the availability of INFLECTRA (infliximab) in Canada, the country's first subsequent entry biologic (SEB) monoclonal antibody (mAb) therapy.

30 Mar 2015

Samsung Bioepis submits second biosimilar candidate MAA to EMA

Samsung Bioepis Co., Ltd., today announced that the Marketing Authorization Application (MAA) for SB2, its Remicade (Infliximab) biosimilar candidate, has been submitted to the European Medicines Agency (EMA).

13 Mar 2015

Mundipharma launches Remsima® (infliximab), a new-generation value-based monoclonal antibody, in six European markets

Mundipharma International Limited’s network of independent associated companies are launching Remsima® (infliximab) this month in Germany, Italy, UK, Netherlands, Belgium and Luxembourg following expiry of the relevant patents and Supplementary Protection Certificates, having secured distribution rights from Celltrion Healthcare Hungary Kft for Remsima in these markets.

1 Mar 2015

Hospira launches first biosimilar monoclonal antibody (mAb) InflectraTM (infliximab) in the UK

Inflectra is licensed for the treatment of inflammatory conditions including rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, adult and paediatric ulcerative colitis and plaque psoriasis.

26 Feb 2015

Remsima (infliximab) now available in Europe for treatment of autoimmune diseases

Celltrion Healthcare has today announced the launch of Remsima (infliximab) in 12 European markets: Austria, Belgium, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain, Sweden and the UK.

26 Feb 2015

InflectraTM (infliximab) patient registry reports interim results in the treatment of inflammatory bowel disease

Data have been presented today on the use of Hospira’s Inflectra (infliximab), the world’s first approved biosimilar monoclonal antibody (mAb), at the European Crohn’s and Colitis Organisation Inflammatory Bowel Diseases (ECCO-ibd) conference.

19 Feb 2015

Hospira announces launch of first biosimilar monoclonal antibody in Europe

Hospira, Inc., a world leader in the development of biosimilar therapies, today announced the launch of the first biosimilar monoclonal antibody (mAb), Inflectra (infliximab), in major European markets.

16 Feb 2015

Amgen's biosimilar Phase 3 rheumatoid arthritis study meets primary and secondary endpoints

Amgen today announced a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared with Humira® (adalimumab) in patients with moderate-to-severe rheumatoid arthritis met its primary and key secondary endpoints.

4 Feb 2015

Mylan announces U.S. launch of Celecoxib Capsules

Mylan Inc. today announced the U.S. launch of its Celecoxib Capsules, 50 mg, 100 mg, 200 mg, and 400 mg, one of the first available generic versions of Pfizer's Celebrex Capsules, which is indicated for the relief of the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and for the management of acute pain in adults.

10 Dec 2014

Variations in ERAP1 enzyme could lead to Ankylosing Spondylitis

Scientists at the University of Southampton have discovered variations in an enzyme belonging to the immune system that leaves individuals susceptible to Ankylosing Spondylitis.

10 Dec 2014

Zydus Cadila becomes world's first company to launch biosimilar of Adalimumab

After more than a decade-long wait, the revolutionary therapy that provided a new lease of life to millions of patients suffering from rheumatoid arthritis and other auto immune disorders globally will now be accessible to patients in India. Zydus Cadila becomes the first company anywhere in the world to launch the biosimilar of Adalimumab - the world's largest selling therapy.

9 Dec 2014

AbbVie’s Phase 3 pivotal study shows HUMIRA is effective in reducing symptoms in HS

AbbVie today announced results from a Phase 3 pivotal study demonstrating that HUMIRA® (adalimumab) is effective in reducing common clinical signs and symptoms in moderate-to-severe hidradenitis suppurativa (HS), specifically the number of abscesses and inflammatory nodules.

11 Sep 2014

Decision Resources expands disease-level coverage of Treatment Algorithms Insight Series

Decision Resources has expanded its disease-level coverage of the Treatment Algorithms Insight Series, which examines U.S. physicians' prescribing behavior, to provide a quantitative analysis of an agent's penetration into each line of therapy.

19 Aug 2014

UCB, Dermira enter into licensing agreement for development, commercialization of Cimzia

UCB, a global biopharmaceutical leader, and Dermira, Inc., a privately held US-based dermatology company, announced today that they have entered into an exclusive licensing agreement for the development and future commercialization of Cimzia (certolizumab pegol) in dermatology.

3 Jul 2014

Infliximab biosimilar CT-P13 improves disease activity in patients with Ankylosing Spondylitis

New data presented today at the European League Against Rheumatism Annual Congress (EULAR 2014) show that the newly-approved infliximab biosimilar CT-P13 achieves statistically similar improvements in disease activity, disability and mobility in patients with Ankylosing Spondylitis (AS) compared to its original reference product infliximab (INX).

13 Jun 2014

AbbVie's ALIGN study underscores patients’ attitudes and adherence toward TNF inhibitors

AbbVie today announced results from its multi-country ALIGN study, which shows that across six chronic immune-mediated inflammatory diseases (IMIDs), adherence to treatment was generally higher in patients being treated with TNF inhibitors compared to patients treated with conventional therapy.

11 Jun 2014

AbbVie receives HUMIRA orphan drug designation from FDA for treatment of non-infectious uveitis

AbbVie announced today that the U.S. Food and Drug Administration has granted HUMIRA orphan drug designation for the treatment of non-infectious intermediate, posterior, or pan-uveitis, or chronic non-infectious anterior uveitis, a group of rare but serious inflammatory diseases of the eye.

21 May 2014

NPF researchers to get access to Corrona’s psoriatic arthritis registry to improve patient outcomes

To improve treatment decisions and patient outcomes for psoriatic arthritis (PsA)—a chronic inflammatory arthritis that affects the joints and tendons—the National Psoriasis Foundation and Corrona, LLC are collaborating to give NPF-affiliated researchers access to Corrona’s psoriatic arthritis registry, which is the largest psoriatic arthritis registry in the world.

25 Apr 2014

Reduced rheumatoid arthritis risk in schizophrenia linked to underreporting

People with a history of schizophrenia appear to have a lower risk of developing rheumatoid arthritis than the general population, but the association may be due to underreporting, say researchers.

16 Apr 2014