May 16th 2024
Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.
Pharma's Creative Strategies to Hold Off Generic, Biosimilar Competition
September 16th 2017Last 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.
A European Perspective on Biosimilars
September 13th 2017At 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.”
AAM Executive: 1.2 Million Will Gain Treatment Access Because of Biosimilars
September 12th 2017Christine 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.
Coherus Fails in Challenge of Humira Patent, AbbVie Releases Phase 3 Results for New RA Drug
September 11th 2017Coherus 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.
TNF-alpha Inhibitors Less Effective After RA Patients Discontinue Etanercept
September 7th 2017Although 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.
When Will Patients Benefit From Deepening Infliximab Discounts?
September 6th 2017Seth 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.”
REDO Trial Will Help Answer Questions About Ultra-Low-Dose Rituximab Therapy
September 5th 2017Several 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.
Baricitinib Outperforms Adalimumab in PROs in Phase 3 Study
September 5th 2017Newly 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).
First WHO International Reference Standard Established for Etanercept
September 4th 2017Several 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.
EAHP Position on Biosimilars Contrasts With US Regulation on Naming, Interchangeability
September 2nd 2017The European Association of Hospital Pharmacists (EAHP), a professional organization that represents over 21,000 hospital pharmacists in 35 European countries, recently released a position paper on biosimilar medicines.
Some Psoriasis Patients Treated with Above-Label Use of Biologics, Leading to Higher Costs
August 30th 2017A retrospective study using a large US claims database of patients with moderate to severe psoriasis suggests that extensive above-label use of etanercept, adalimumab, and ustekinumab occurs in many patients who take these biologics, and leads to higher costs.
Tapering, Withdrawal of Anti-TNFs Associated With Lower Costs, Worse Disease Control
August 29th 2017Treatment strategies involving anti-tumor necrosis factor dose tapering or withdrawal among rheumatoid arthritis patients who are achieving disease control are gaining popularity. Such strategies seek to optimize benefits versus risks with respect to both patient preferences and the high costs of biologic treatments.
Study: Patients and Providers Prefer Biosimilar Etanercept's Auto-Injector
August 29th 2017A recently published study found that the auto-injector device used to deliver a biosimilar etanercept was preferable to the auto-injector device used to deliver reference etanercept (Enbrel) among patients with rheumatoid arthritis and healthcare providers who treat patients with RA.
Coherus Announces Positive Topline Results for CHS-1420 Days After BI Receives Approval for Cyltezo
August 28th 2017Coherus BioSciences today announced positive topline results for the first of 3 pharmacokinetic bioequivalence studies comparing CHS-1420, an adalimumab biosimilar candidate, and European-sourced reference Humira.
Samsung Bioepis Gains EU Approval for Adalimumab Biosimilar
August 25th 2017Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, announced that it has received the European Commission’s (EC) approval for its adalimumab biosimilar (Imraldi), referenced on AbbVie’s blockbuster Humira.