Rheumatology

Republican efforts to repeal and replace the Affordable Care Act may have stalled once again with the failure of the Graham-Cassidy bill on Thursday, but advocacy groups intend to keep healthcare—and the high cost of prescription drugs—at the forefront of Congress’ agenda.

A large Canadian study of patients with inflammatory diseases, including rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, reports that a high overall rate of adherence to subcutaneous anti-TNFs.

The FDA has issued a complete response letter (CRL) for Johnson and Johnson’s proposed rheumatoid arthritis (RA) drug, sirukumab. Janssen Biotech, a division of Johnson and Johnson, had filed a Biologics License Application (BLA) for the interleukin-6 (IL-6) inhibitor, including data from a global phase 3 clinical development program, in September 2016.

At the 26th Congress of the European Academy of Dermatology and Venereology in Geneva, Switzerland, Sandoz announced positive data from a phase 3 confirmatory study to compare the efficacy and safety of Sandoz’s proposed biosimilar adalimumab, GP2017, with its reference.

The FDA has approved, to date, 7 biosimilar treatments.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 18, 2017.

Trends in data concerning publicly and privately insured patients with rheumatoid arthritis show that the use of bioloigic disease-modifying antirheumatic drugs (DMARDs) is on the rise.

When a patient fails to respond or no longer responds to one biologic disease-modifying antirheumatic drug due to a lack of efficacy or poor tolerability, switching to another bDMARD can be a safe and effective treatment strategy.

Samsung Bioepis has gained government clearance to begin a phase 3 clinical trial of its ranibizumab biosimilar in the Republic of Korea.

In recent years, a wrench has been thrown into the patient care equation.

This Rheumatic Disease Awareness Month, Stanley Cohen, MD, medical director of the Metroplex Clinical Research Center and clinical professor of internal medicine at the University of Texas Southwestern Medical School, has a message for patients: biosimilar treatments are just as safe and effective as originator biologics in treating rheumatic diseases.

Brandon Shank, PharmD, MPH, BCOP, Clinical Pharamcy Specialist, discusses the merits of the current biosimilar naming system.

Last week, Irish drug maker Allergan announced that it had transferred its patents for its cyclosporine ophthalmic emulsion, Restasis, to the Saint Regis Mohawk Tribe. Allergan said in a statement that the Tribe now owns all Orange Book-listed patents for the dry eye treatment, and that the Tribe is filing for a motion to dismiss an ongoing inter partes review on the basis of sovereign immunity.

On Friday, the European Medicines Agency's Committee for Medicinal Products for Human Use issued positive opinions on 2 biosimilar candidates.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 11.

At the 2017 AAM Biosimilars Council Conference, Adrian van den Hoven, director general of Medicines for Europe, contradicted the conventional thinking about biosimilars, saying that biosimilars do not simply reduce costs of treatment. Instead, he said, they deliver “huge additional health benefits to patients.”

Christine Simmon, senior vice president of policy and strategic alliances for the Association for Accessible Medicines (AAM) and executive director of The Biosimilars Council, told The Center for Biosimilars® at the 2017 AAM Biosimilars Council Conference that upcoming product approvals in the biosimilar space are exciting prospects not only for the industry, but, most importantly, for patients.

Sandoz announced today that the FDA has accepted its Biologics License Application (BLA) for a proposed rituximab biosimilar. The drug is referenced on Rituxan, which is approved to treat blood cancers and immunological diseases.

Marcus H. Snow, MD, Assistant Professor Rheumatology, University of Nebraska, discusses concerns about automatic substitution of biosimilars for reference products.

Biosimilar developer Oncobiologics has announced a new strategic partnership with Singapore-based GMS Tenshi Holdings.

Coherus BioSciences has announced that its petition for inter partes review of AbbVie’s US Patent 9,085,619, covering the formulation of adalimumab (Humira), was not instituted by the Patent Trial and Appeal Board.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of September 4, 2017.

Although switching patients with rheumatoid arthritis to a second biologic disease-modifying anti-rheumatic drug when their disease has failed to respond to the first agent is generally advocated, no consensus exists on whether the second agent should have the same or a different mechanism of action.

Biologic agents represent the highest single cost associated with rheumatoid arthritis (RA) infusion care, a new analysis finds, with personnel, supplies, and overhead costs contributing substantially to overall costs.

Seth D. Ginsberg, co-founder of Global Healthy Living Foundation, told The Center for Biosimilars®, “Currently the benefit of rebating and pricing of all infused drugs goes to the payers, health systems, hospitals and physicians, not the patients. Until patients participate in such savings, infused drug pricing has nothing to do with them.”

Several small studies have suggested that ultra–low-dose treatment with rituximab leads to good treatment responses in patients with rheumatoid arthritis compared with standard low-dose schedules of rituximab.

Newly published results of a phase 3 study of baricitinib, a once-daily oral Janus kinase inhibitor for the treatment of moderate to severe rheumatoid arthritis (RA), show that the small-molecule drug provided greater improvements in patient-reported outcomes than either placebo or the biologic adalimumab (Humira).

Several biosimilar etanercept products are now approved in the United States and in Europe, and several more “intended copy” versions are approved in poorly regulated countries. Availability of an international reference standard would allow qualification of assays for determining biological activity of intended copies or biosimilars.

The past weeks have seen a number of important milestones for biosimilars, from product approvals and regulatory changes to policy updates and litigation developments.

Competition for the $16 billion market for Humira is heating up with new approvals for adalimumab biosimilars in the United States and European Union.