When Can Biologic Patent Disputes Go Before the ITC?
June 25th 2019Under which situations might the International Trade Commission (ITC) be the right choice for biosimilar patent disputes instead of federal district court? A panel discussed these questions at the ACI 10th Summit on Biosimilars on Monday in New York City.
Deputy Director Talks About Implementing Biosimilar Policy Within the FDA
June 24th 2019With a variety of policy ideas circulating around Washington, DC, in regards to stimulating biosimilar competition and lowering drug prices, the role of the FDA is to provide technical assistance to those legislative staffers and others looking for information, a key FDA official told a packed audience at the ACI 10th Summit on Biosimilars on Monday in New York City.
Interim Results From REFLECT Show No New Safety Concerns for Biosimilar Rituximab, Rixathon
June 20th 2019During last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, researchers presented their interim safety results from the REFLECT study, a prospective, noninterventional, observational, multicenter, open-label study of the biosimilar rituximab Rixathon as a curative therapy with cyclophosphamide, doxorubicin, vincristine, and prednisone in patients with previously untreated CD20-positive diffuse large B-cell lymphoma.
Real-World Data Reaffirm Biosimilar Filgrastim's Safety and Efficacy
June 19th 2019During the 24th European Hematology Association (EHA) Congress, researchers from the European branch of the Severe Chronic Neutropenia International Registry reported on experience with reference granulocyte colony-stimulating factor products and a biosimilar.
Celltrion Presents More Data Showing Comparable Efficacy, Safety of Subcutaneous CT-P13 to IV Form
June 19th 2019Korean drug maker Celltrion Healthcare recently presented new findings from a 2-part study at the European League Against Rheumatism European Congress of Rheumatology 2019 meeting about subcutaneous biosimilar CT-P13 (Inflectra, Remsima).
Four Studies Report Real-World Data on Biosimilar Rituximab, Truxima
June 18th 2019The FDA recently approved biosimilar rituximab CT-P10, or Truxima. While the drug is not yet available in the United States, data are accruing for its use in Europe. During last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, 4 groups of researchers reported on real-world data that support the use of the biosimilar in cancer care.
Amgen's Eculizumab Biosimilar, ABP 959, Shows PK, PD Bioequivalence to Soliris
June 18th 2019Amgen is developing a biosimilar of the drug, ABP 959, and during last week’s 24th Congress of the European Hematology Association, held from June 13-16 in Amsterdam, the Netherlands, researchers reported on findings from a phase 1 trial of the proposed product.
In the Short Term, Most Patients With RA Remain on a Biosimilar Post Switch
June 16th 2019During this week’s European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology, researchers from the University of Manchester reported on their findings regarding patients with rheumatoid arthritis (RA) involved in the BSRBR-RA study who had switched from reference infliximab or reference etanercept to biosimilars.
Biosimilar Adalimumab, Hulio, Is Safe Long-Term, Causes Less Injection-Site Pain Than Humira
June 14th 2019During this week’s European League Against Rheumatism Annual European Congress of Rheumatology, researchers will present on the long-term safety, immunogenicity, and efficacy of the biosimilar versus the reference in an open-label extension study that involved switching between the biosimilar and the reference.
Real-World Data on SB4 Highlight Biosimilar Etanercept's Efficacy
June 12th 2019During this week’s European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology, multiple teams of researchers will present their findings on real-world evidence of the biosimilar’s efficacy and the feasibility of switching to SB4 from the reference etanercept, Enbrel.
Amgen's Trastuzumab Biosimilar, Kanjinti, Clinically Similar to Herceptin in Cardiac Safety
June 6th 2019During this week’s 2019 American Society of Clinical Oncology Annual Meeting, researchers reported on the cardiac safety of Amgen’s biosimilar trastuzumab, ABP 980 (approved in the European Union under the name Kanjinti), versus the reference trastuzumab, Herceptin.
Developers Provide Updates on 3 Biosimilar Pegfilgrastim Programs
June 5th 2019Multiple biosimilars of pegfilgrastim are available in both the United States and Europe, and the field of competitors to Amgen’s brand-name Neulasta continues to expand. During the 2019 American Society of Clinical Oncology Annual Meeting, 3 research teams shared their findings on biosimilar pegfilgrastim development programs from sponsors Sandoz, Fresenius Kabi, and Gema Biotech.
Real-World Data Underscore the Safety and Highlight the Acceptance of Biosimilar Rituximab
June 4th 2019While no biosimilar rituximab products have yet become available in the United States, biosimilar rituximab products are available in the European Union, and data on their use, published concurrently with the 2019 American Society of Clinical Oncology Annual Meeting, highlight not only their safety but also their growing acceptance among prescribers in Europe.
Phase 3 and Postmarketing Data Support the Efficacy and Safety of Biosimilar Trastuzumab, Ogivri
June 4th 2019During this week’s 2019 American Society of Clinical Oncology Annual Meeting, researchers presented the final overall survival results from the phase 3 HERITAGE study of biosimilar trastuzumab, Ogivri. In addition, another research group shared its findings on postmarketing surveillance of Ogivri in Brazil.
Biosimilar Pegfilgrastim Can Increase Access, but Patient Perception Remains a Biosimilar Barrier
June 3rd 2019During the 2019 American Society of Clinical Oncology Annual Meeting, researchers said that, for payers with large populations, the discounted biosimilar pegfilgrastim can produce substantial cost savings that can be applied to offer increased access to supportive care.
No Significant Difference in EFS, OS Between Herceptin and Biosimilar, Ontruzant, at 3 Years
June 3rd 2019Between patients treated with the biosimilar and those treated with the reference product who were not exposed to lots of Herceptin with lower antibody-dependent cell-mediated cytotoxicity, no difference was observed in event-free survival (EFS) or overall survival (OS).
Biosimilar Monotherapy Sequence for RA Can Be Considered Cost-Effective, Study Finds
May 21st 2019Rheumatoid arthritis (RA) has a considerable economic burden, and costly biologics, are often restricted to cases in which patients fail to respond adequately to methotrexate or other conventional disease-modifying antirheumatic drugs, which may be difficult for some patients to tolerate.
Researchers Predict Substantial Savings for Europe on the Strength of Biosimilar Adalimumab
May 21st 2019During the ISPOR 2019 annual meeting, teams of investigators presented data estimating just how much healthcare systems could save by adopting biosimilar adalimumab for all indications of its reference in adult patients. The results highlighted both the scale of potential savings and the variability among European nations.
Health Plan Restrictions Likely to Have an Impact on Biosimilars, Orphan Drugs
May 20th 2019Despite their benefits to patients, innovative treatments, including biologics, come at a high cost to the healthcare system, and those in a position to make coverage decisions for these products must grapple with these therapies’ affordability. During the ISPOR 2019 meeting, researchers presented findings on how health plan restrictions could limit orphan drug coverage—and encourage biosimilar use—as a means to manage their budgets.
Researchers Present Findings on Patient Preferences, Outcomes With G-CSFs
May 18th 2019During this week’s meeting of the International Society for Pharmacoeconomic and Outcomes Research, held from May 18 to 22 in New Orleans, Louisiana, researchers presented findings on both the patient attitudes toward granulocyte colony-stimulating factor (G-CSF) therapies and their effectiveness in the prophylaxis of febrile neutropenia.
Inside the UK Switch to Biosimilar Adalimumab
May 15th 2019During the Biosimilars Commercialisation Summit, held May 14-15, 2019, in Amsterdam, the Netherlands, a specialist pharmacist for a large National Health Service healthcare trust explained how the transition to biosimilars worked at a practical level in the UK home care system, and shared lessons learned from the experience.
The Need for and Realities of Biosimilars in Generating Health System Savings
May 15th 2019During the Biosimilars Commercialisation Summit 2019, held May 14-15 in Amsterdam, the Netherlands, among the key topics of discussion was the sustainability of the world’s healthcare systems and the need to create savings in order to continue to advance the treatment of cancer and chronic diseases.