Researchers Present on Making AS Treatment More Affordable and More Effective
September 20th 2018Treating ankylosing spondylitis (AS) is costly, even in high-income nations. In lower-income countries, patients may face serious challenges in accessing high-cost drugs, like anti–tumor necrosis factor agents, even when biosimilars are available.
Effective Switches to Biosimilars Feature in APLAR Research
September 19th 2018During the 20th Asia Pacific League of Associations for Rheumatology (APLAR) Congress, held September 6 to 9 in Kaohsiung, Taiwan, researchers presented on real-world experience with switching to biosimilars in treating rheumatic diseases.
Lawsuit: AbbVie Used Kickbacks and Nurse Ambassadors to Boost Humira Sales
September 19th 2018The State of California has filed suit against drug maker AbbVie, alleging that the company provided kickbacks to healthcare providers throughout the state to encourage them to prescribe its brand-name adalimumab, Humira, and used a network of registered nurses to mislead patients about the risks associated with the drug.
Senate Passes Bill Addressing Gag Clauses and Biosimilar Settlements
September 18th 2018The bill, introduced in March 2018 by Senator Susan Collins, R-Maine—together with Senators Claire McCaskill, D-Missouri, and Debbie Stabenow, D-Michigan—eliminates so-called “gag clauses” that prevent pharmacies from telling consumers whether they could spend less on their medication by paying out-of-pocket.
Researchers Report Positive Early Data for Cetuximab Biosimilar
September 18th 2018Cetuximab (Erbitux), an anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody used in the treatment of head and neck and colorectal cancer, so far faces no biosimilar challengers. However, Chinese researchers are reporting positive preclinical results for a proposed biosimilar, APZ001.
For First-Line Monotherapy for RA, Etanercept Is Preferable, Analysis Finds
September 18th 2018The improved efficacy of a biologic drug in combination with a conventional treatment in rheumatoid arthritis (RA) has been well demonstrated, but some biologic-naive patients are unable to tolerate drugs such as methotrexate. Limited data are available about which biologic to select for monotherapy in such patients, however.
EMA Publishes New Educational Materials on Biosimilars
September 17th 2018On September 13, the European Medicines Agency (EMA) published new, patient-focused materials that aim to make patients aware of biosimilar medicines and how the EMA assures that they are as safe and effective as reference biologics.
Patients With CLL Who Have Anaphylaxis With Obinutuzumab May Be Able to Receive Rituximab
September 16th 2018Rituximab-based immunochemotherapy can be safely applied in patients after obinutuzumab-associated anaphylaxis, but the existing risk of cross­reactivity should be considered, and careful monitoring of such patients during rituximab infusion is required.
Review Urges Better Guidelines for Optimal Management of Patients With Crohn Disease
September 14th 2018Up to 60% of Crohn disease patients taking an anti—tumor necrosis factor (TNF) monoclonal antibody medication eventually stop responding to treatment, but the optimal management of these patients has not been clearly defined.
Study Suggests Predictive Biomarker for Therapeutic Outcomes in Ankylosing Spondylitis
September 14th 2018A new study suggests that CD8+ natural killer cells are a biomarker that can predict therapeutic outcome for patients with ankylosing spondylitis who are administered anti–tumor necrosis factor agents because they are nonresponsive to conventional treatment.
ODAC to Discuss Celltrion's CT-P10 in October 2018
September 12th 2018Korean drug maker Celltrion says that the FDA’s Oncologic Drugs Advisory Committee (ODAC) will convene to discuss the Biologics License Application (BLA) for CT-P10, a proposed biosimilar rituximab, on October 10, 2018. CT-P10 is already authorized in the European Union, where it was approved under the trade names Rituzena, Ritemvia, Truxima, and Blitzima.
United Kingdom Hopes to Lure Biosimilar Developers for Clinical Trials
September 11th 2018The National Institute for Health Research's Clinical Research Network maintains an active list of more than 800 clinicians—practicing in oncology, gastroenterology, endocrinology, and dermatology—who are interested in delivering trials of biosimilar medicines.
Eye on Pharma: Xbrane to Shift Its Focus to Biosimilars
September 11th 2018Xbrane’s lead biosimilar candidate is a ranibizumab product (referencing Lucentis), developed in collaboration with Stata, that is moving into a pivotal clinical trial. The study will enroll patients with wet age-related macular degeneration across 16 countries.
How Will Seniors Be Impacted by the Trump Administration's Medicare Policy?
September 10th 2018Since its inception, one of the best features of public and private Medicare Part B has been that patients are able to access their treatments without delay. That’s why healthcare providers, in collaboration with the patient, should be the primary treatment decision-makers. “Fail-first” policies prevent patients from receiving the right medication at the right time, and seniors can’t live with delays or risk disease destabilization.
Study: Biosimilar Filgrastim Associated With Fewer Adverse Events than Biosimilar Pegfilgrastim
September 10th 2018While both the biosimilar filgrastim and biosimilar pegfilgrastim were effective in reducing the incidence of neutropenia, adverse events related to granulocyte-colony stimulating factor therapy were significantly higher in patients who received pegfilgrastim.
IQVIA Report Assesses Long-Term Sustainability of the Biosimilars Marketplace
September 6th 2018The European Union already has far more approved biosimilars—45 products referencing 15 medicines—than does the United States, but as a newly released report from IQVIA states, the number of European biosimilars available today represents just a fraction of what the market is expected to contain in the coming years, raising questions about the sustainability of the market.
In the Debate Over Interchangeability, What Can the United States Learn From Europe?
September 6th 2018Writing in the European Medical Journal, Anna La Noce, MD, PhD, and Marcin Ernst, MD, MBA, explain that much confusion about switching between biosimilars and reference products in the United States versus in the European Union arises from different uses of the term “interchangeability.”
Celltrion Asks NHS to Start Biologics Earlier in Patients With RA
September 5th 2018Currently, UK eligibility criteria for starting biologics in patients with rheumatoid arthritis (RA) set a threshold of a disease activity score in a count of 28 joints of 5.1 or higher—the threshold for severe disease—on at least 2 occasions measured 1 month apart.
FDA's Public Hearing on Biosimilar Action Plan Draws Wide Stakeholder Involvement
September 5th 2018Though biosimilars have the potential to provide a less costly option for patients, the products have not seen the uptake in the marketplace that the FDA had expected. This apprehension was reiterated in FDA Commissioner Scott Gottlieb’s comments at the meeting: “I’m not satisfied with the current state of the biologics market and biosimilars in particular.”
New Zealand's Pharmac Proposes Funding Only Biosimilar Epoetin Alfa
September 4th 2018Janssen’s drug, sold in New Zealand as Eprex (and in the United States as Epogen) would lose funding after a transition period beginning in February 2019. After the close of the transition, only Novartis’ approved biosimilar, sold as Binocrit, would be eligible for funding in community and hospital settings.