FDARA May Be Delayed, But So Are FDA Layoffs
July 31st 2017The Senate may not consider the FDA Reauthorization Act (FDARA) until early September, after the congressional recess. The delay comes after Senator John McCain (R-Arizona) returned to the capitol to vote in favor of advancing a debate over healthcare reform.
A Look at the Regulatory Process for Approval of Biosimilar Insulins in Europe
July 29th 2017The emergence of biosimilar insulins may help broaden access to modern insulins, increase individualized treatment options, and reduce the cost of insulin therapy. Yet many healthcare providers may not understand the concept of biosimilarity and how biosimilar medications are similar, not identical, to their reference products.
Review Examines Immunogenicity Rates in Patients Taking Innovator Biologics, Biosimilars
July 28th 2017The potential immunogenicity of biosimilar agents is an important consideration in the treatment decision-making process, and a new systematic review of immunogenicity associated with biological therapies in chronic inflammatory diseases explores the frequency of immunogenicity and its potential impact on efficacy and safety.
US House Votes to Fund Home Infusion, CMS Proposes Cuts to Home Healthcare
July 26th 2017This week, the House of Representatives passed the Medicare Part B Improvement Act, a bipartisan bill that, among other provisions, seeks to amend title XVIII of the Social Security Act in order to address the delivery of at-home infusion therapy.
Adalimumab Biosimilar CinnoRA Noninferior, Comparably Safe to Humira
July 25th 2017The prospective adalimumab biosimilar CinnoRA was shown in a recently published phase 3 trial to be comparable to AbbVie’s innovator biological treatment Humira in terms of safety and efficacy in adult patients with active rheumatoid arthritis.
Awareness of Biosimilars High Among Irish Specialist Physicians, Pharmacists; Less So Among GPs
July 25th 2017A new survey assessing awareness of and attitudes about biosimilars among medical specialists and pharmacists in Ireland found that majority of such experts say that they are familiar or very familiar with the term “biosimilar,” but many general practitioners (GPs) were either unable to define or had never heard the term.
Merck Wins Tentative FDA Approval of Follow-on Insulin Glargine
July 21st 2017The FDA has granted Merck’s insulin glargine (Lusduna Nexvue) tentative approval. Merck says that its follow-on basal insulin has met all required regulatory standards of clinical and nonclinical safety, efficacy, and quality for follow-on biologics.
Facing Challenges From Biosimilars, Roche Hopes to Retain Dominance With New Products
July 20th 2017Last week’s Oncologic Drugs Advisory Committee recommendation that the FDA approve 2 biosimilar treatments brought Swiss drug maker Roche a step closer to inevitable competition from biosimilar treatments.
Critical Reflection and Global Regulatory Alignment of Complex Drugs Needed
July 20th 2017The cost of developing copy versions of complex drugs—biosimilars and follow-ons for biologics and copies of nonbiological complex drugs such as nanomedicines, including drug-carrying liposomes—can be decreased, according to a new white paper.
Phase 3 Trial of Rituximab Biosimilar Candidate GP2013 Shows Positive Results in Follicular Lymphoma
July 19th 2017Primary results from the ASSIST-FL Phase 3 clinical trial of GP2013, a proposed biosimilar of reference rituximab (Roche’s Rituxan, MabThera), showed that GP2013 is a viable rituximab biosimilar candidate for patients with previously untreated advanced follicular lymphoma.