News

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.

The FDA has published its Biosimilar User Fee Act (BsUFA) rates for 2018. The Biosimilar User Fee Amendments of 2017 (BsUFA II) authorize the agency to assess and collect fees from applicants for biosimilar products from October 2017 to September 2022.

A recent study found that enrollment in patient support programs was associated with greater adherence, improved persistence, and reduced medical and total healthcare costs for patients who were receiving adalimumab therapy.

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.

Drug maker Pfizer announced today that it has filed a district court lawsuit in the Eastern District of Pennsylvania against Johnson and Johnson.

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.

A retrospective case series suggests that low-level anti-tumor necrosis factor anti-drug antibodies in patients with inflammatory bowel disease may be overcome by dose escalation and/or addition of an immunomodulator, which can allow for clinical improvement in disease status.

Last week, CMS closed its comment period on the 2018 Revisions to Payment Policies under the Physician Fee Schedule. Multiple stakeholder groups within the biosimilars industry submitted comments to CMS with respect to its policy on biosimilar reimbursement.

Last week, England’s National Health Service released a commissioning framework for biological medicines, including biosimilars.

This month, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO), trade groups representing the biopharmaceutical and biotechnology industries, announced that they are challenging Nevada’s Senate Bill (SB) 539 in district court litigation.

In an effort to provide a guide for clinicians and a framework for future educational efforts, an international panel of healthcare stakeholders convened to arrive at consensus recommendations for the use of biosimilars to treat rheumatological diseases.

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.

Social media posts by patients with Crohn’s disease are a useful data set to understand patient perspectives on treatment with infliximab (Remicade), according to a new study.

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

On Wendesday, Republican senators introduced HR 1628, a new effort to repeal and replace the Affordable Care Act.

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

The FDA has approved Mvasi, the first biosimilar bevacizumab (Avastin).

On Monday, the United States filed an amicus brief with the Federal Circuit in the case of Amgen v Sandoz. The brief addresses whether the Biologics Price Competition and Innovation Act (BPCIA) preempts additional remedies under state law for an applicant’s failure to comply with the so-called “patent dance.”

Adello Biologics, a New Jersey-based biosimilar developer previously named Therapeutic Proteins International, announced this week that its Biologics License Application (BLA) for a biosimilar filgrastim candidate has been accepted for review by the FDA.

According to a new study, potential savings realized from transitioning to treatment with biosimilar filgrastim-sndz from reference filgrastim are not only significant, but these savings can also be applied to expand access to novel immunotherapies or supportive care.

How can the US healthcare system learn from the European Union on market penetration for biosimilar products?

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.

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.

How much money can biosimilar filgrastim save, and how can health systems encourage uptake? This infographic outlines 7 key concepts.

The FDA has issued new draft guidance on how biologic product sponsors should address postapproval changes in chemistry, manufacturing, and controls.

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

The US Senate’s Committee on Health, Education, Labor, and Pensions held the first 2 of its 4 full committee hearings on stabilizing the Affordable Care Act’s individual insurance market. Testifying on Wednesday and Thursday were state insurance commissioners and state governors, respectively. Across the 2 days of testimony, key themes emerged.