Policy Differences Among European Nations Affect Biosimilar Uptake
January 5th 2018While the European experience with biosimilars is one of significant uptake of biosimilars, individual European nations have had distinctly different levels of uptake. These differences are largely due to local variation in pricing and reimbursement, education levels, population characteristics, and stakeholder incentives.
Study Demonstrates Real-World Safety, Effectiveness of Biosimilar Epoetin Alfa for Renal Anemia
January 4th 2018Patients with renal anemia undergoing hemodialysis who were treated for up to 24 months with the intravenous biosimilar epoetin alfa HX575 (Binocrit) showed hemoglobin outcomes equivalent to reference epoetin alfa.
Saint Regis Mohawk Tribe Seeks Discovery Into PTAB in Ongoing Battle Over Restasis
January 4th 2018On January 2, counsel for the Saint Regis Mohawk Tribe filed a motion for discovery and requested an oral hearing concerning which judges will sit on the Patent Trial and Appeal Board (PTAB) panel that oversees its case.
Momenta and Mylan Announce Clinical Trial of Proposed Aflibercept Biosimilar
January 4th 2018Momenta Pharmaceuticals and Mylan have announced that they will begin a pivotal clinical trial of their jointly developed M710, a proposed biosimilar of the anti–vascular endothelial growth factor (anti-VEGF) therapy aflibercept, referenced on Eylea.
Indian Drug Maker Hetero Launches Adalimumab Biosimilar, Mabura
January 4th 2018Today, Indian drug maker Hetero launched a biosimilar of adalimumab (referenced on Humira, made by AbbVie) to be marketed in India under the name Mabura. This is the fourth biosimilar Hetero has brought to the Indian market.
Study: Switching to Biosimilar Infliximab Does Not Affect Phosphorylation Levels
January 3rd 2018A new study used flow cytometry to compare phosphorylation levels of intracellular epitopes in peripheral blood mononuclear cells from patients with psoriasis in clinical remission who were treated with reference infliximab versus healthy controls, and further evaluated whether a switch from reference infliximab to biosimilar CT-P13 affected intracellular phosphorylation patterns.
SB5 Shows Equivalent Response Rate to Humira in Patients With Rheumatoid Arthritis
January 3rd 2018A phase 3 trial of SB5, a proposed biosimilar to adalimumab (AbbVie’s Humira), showed that SB5 was equivalent to its reference with respect to the American College of Rheumatology's 20% improvement criteria (ACR20).
Phase 3 Study Shows Similarity of LBEC0101 to Reference Etanercept
January 3rd 2018A newly published study evaluating LG Chem's proposed biosimilar etanercept in comparison with its reference (Enbrel) found that LBEC0101 had equivalent clinical efficacy and a comparable safety profile to the reference etanercept, and that the proposed biosimilar was well tolerated.
Study Identifies Contributing Factors to Systemic Treatment Non-Adherence in Psoriasis
January 1st 2018The Psoriasis Stratification to Optimize Relevant Therapy (PSORT) study assessed real-world levels of self-reported non-adherence to traditional systemic and biologic therapies used for psoriasis, and evaluated psychological and biomedical factors associated with non-adherence using multivariable analyses.
Mylan and Biocon Gain Brazilian Regulatory Approval for Trastuzumab Biosimilar
January 1st 2018Mylan and Biocon ended 2017 with more positive news for their biosimilar program; on December 29, 2017, the partnership announced that Brazil’s National Sanitary Surveillance Agency (ANVISA) had approved their trastuzumab biosimilar.
Study: Bevacizumab Should Not Be Withheld in Multifocal Glioblastoma
January 1st 2018Bevacizumab is employed cautiously in patients with multifocal glioblastomas rather than single glioblastomas because of a fear, based on unconfirmed preclinical data, that bevacizumab can increase the invasive tumor phenotype.
Disability as a More Objective Measure in Inflammatory Bowel Disease
December 30th 2017As the treatment paradigm in inflammatory bowel disease (IBD) has shifted from controlling symptoms to fully controlling disease in order to prevent organ damage and disability, some have argued that disability is a better, more objective measure than quality of life in clinical trials and population studies of IBD.
Biosimilar Tbo-Filgrastim Poses Unrealized Potential for Cost Savings
December 29th 2017In 2008, tbo-filgrastim (Granix) was approved as a biosimilar in Europe. In 2012, it was approved in the United States as a follow-on biologic product to filgrastim. Tbo-filgrastim was less expensive than filgrastim, and clinical information and expert opinion supported similarity between the products. This led the pharmacy and therapeutics committee of a major US health system to approve tbo-filgrastim as the preferred granulocyte-colony stimulating factor (G-CSF) product in March 2014.
First Brazilian Study of Adalimumab to Treat Ulcerative Colitis Demonstrates Efficacy and Safety
December 29th 2017Adalimumab demonstrated efficacy and safety in the treatment of patients with moderate to severe ulcerative colitis (UC) in the first Brazilian study to demonstrate the effectiveness and safety profile of the therapy in patients with UC.
Rick Lozano: Patient Programs, Provider Education Pose Opportunities for Biosimilars
December 28th 2017While 2017 was a busy year for biosimilar approvals by the FDA, Rick Lozano, vice president of biosimilars and integrated business development at AmerisourceBergen, feels that the biggest developments in biosimilars were those being made outside the regulatory or clinical spheres. In an interview with The Center for Biosimilars®, Lozano said that “There are distractions and defense strategies in the market that continue to be slowing the pace” of bringing biosimilars to the market.
Antidrug Antibodies Common, Significantly Impact Biologic Efficacy
December 28th 2017Antidrug antibodies (ADAs) are commonly found in healthy subjects after a single intravenous dose of infliximab and result in faster clearance of infliximab, shorter elimination time, and lower serum infliximab levels, according to a study published in the September 2017 issue of Drugs in R&D by Eli D. Ehrenpreis, MD.
Extrapolation Framework Can Guide Off-Label Determinations for Biosimilars, Study Argues
December 27th 2017In clinical practice, biologics are routinely used for medically accepted off-label indications, and these uses are typically curated by guidelines. A newly published study, led by Edward Li, PharmD, MPH, BCOP, argues that the FDA’s framework for granting the extrapolation of indications for biosimilars can be used by clinicians and payers to determine appropriate off-label uses of biosimilars.