Session Highlights Barriers to Biosimilar Adoption and Lack of Provider, Payer Education
April 17th 2018During a session at the 2018 Community Oncology Conference, hosted by the Community Oncology Alliance April 12-13 in National Harbor, Maryland, Robert M. Rifkin, MD, FACP, medical director of biosimilars at McKesson Specialty Health, The US Oncology Network, highlighted the opportunities biosimilars provide to increase access to drugs while decreasing costs, but also the remaining barriers to adoption.
Patient Support Programs Associated With Greater Likelihood of Controlled AS
April 17th 2018Canadian patients who receive brand-name adalimumab (Humira) to treat ankylosing spondylitis (AS) are eligible for a patient support program, provided by drug maker AbbVie, that includes personalized services such as coaching phone calls before and after initiating treatment.
FDA Finalizes Special Protocol Assessment Guidance for Industry
April 16th 2018The FDA has finalized its guidance on the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research special protocol assessments (SPA). SPA is a process in which product sponsors may ask to meet with FDA to reach an agreement on the design and size of clinical trials and clinical or animal studies to determine whether they adequately address the scientific and regulatory requirements to support eventual marketing approval.
Colombian Regulation Includes 3 Pathways for Biosimilar Approval
April 15th 2018As nations around the world seek to reap the rewards of biosimilar savings, some countries, including Colombia, are updating their regulatory processes to better facilitate the introduction of biosimilars. A paper, recently published in the Generics and Biosimilars Initiative Journal, outlines the new landscape for biosimilar products in Colombia.
FDA's Leah Christl Takes to Reddit to Explain Biosimilars
April 13th 2018On Thursday, Leah Christl, PhD, director of the therapeutic biologics and biosimilars staff at the Center for Drug Evaluation and Research’s (CDER) Office of New Drugs at the FDA, hosted the organization’s first “Ask Me Anything” session about biosimilars on the website Reddit. Christl responded to user questions about the biosimilar approval process, the differences between a biosimilar and an interchangeable product, and pricing.
ACR Says Final Rule on EHB Benchmark Plans Could Reduce Access to Biologics
April 13th 2018This week, the American College of Rheumatology (ACR) raised concerns that CMS’ final 2019 Payment Notice Rule, which provides states with increased flexibility to determine which plan options they can select as Essential Health Benefit- (EHB) benchmark plans and select their own sets of benefits, could seriously jeopardize care for patients with inflammatory diseases.
Mylan on Biosimilars: "If We Don't Have a Product, We'll Go and Find It"
April 12th 2018Mylan's president, Rajiv Malik, said during the company's Investor Day, "If we don’t have a product and the market needs it, we’ll go and find it. Rituximab for Europe is a good example, we didn’t have it in the portfolio for either Biocon or Momenta, but we could find an opportunity…we’ll continue to do this; go out and keep on looking if there are gaps.”
Celltrion Asks for Summary Judgment of Non-Infringement in Inflectra Case
April 12th 2018In ongoing litigation over Celltrion and Pfizer’s infliximab biosimilar, Inflectra, a Massachusetts district court has granted Celltrion’s motion for leave to file a motion for summary judgment of non-infringement.
Oncologist Sees Biosimilars Playing a Role in the Oncology Care Model
April 12th 2018Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, told The Center for Biosimilars® in an interview that, as his practice has begun to implement the Oncology Care Model, it has moved 100% of its patients to biosimilar filgrastim, Zarxio, from the reference filgrastim, Neupogen.
Upadacitinib Superior to Adalimumab in Phase 3 Trial in RA
April 11th 2018AbbVie reports that the trial of 15 mg of orally-administered, once-daily upadacitinib met its primary endpoints, with 71% of patients achieving 20% improvement based on American College of Rheumatology criteria (ACR20), and 29% achieving clinical remission.
Mylan to Partner With Fujifilm Kyowa Kirin Biologics on Adalimumab Biosimilar
April 11th 2018The European Medicines Agency accepted for review a marketing authorization application for the proposed biosimilar, FKB327, in May 2017, and the companies say that they expect to receive the EMA’s decision during the second half of 2018.
Pfizer Execs Underscore the Need for a Level Playing Field for Biosimilars
April 10th 2018In a press briefing today at Pfizer’s headquarters in New York, New York, Pfizer’s executives reviewed their progress with biosimilars to date and underscored the need for a level playing field if biosimilars are to compete with brand-name biologics in the United States.
Misuse of Limited Distribution Networks Prevents Biosimilar Market Entry
April 10th 2018Limited distribution networks, which are established when a drug maker contracts with either 1 or a limited number of distributors, can allow a manufacturer to efficiently manage the supply chain for a given product. However, as a recent paper argues, LDNs can have an anticompetitive impact on the marketplace.
AAM Addresses Relationships with Patient Groups in New Code of Ethics
April 10th 2018In terms of the interactions with patient organizations, the code specifies that companies should not only respect the autonomy of patient organizations and their independence, but also ensure that support for patient advocacy organizations in the form of grants or charitable contributions not be conditional on promoting a specific medicine.
New Database Tracks Pharma's Donations to Patient Advocacy Groups
April 9th 2018The database, called “Pre$cription for Power,” shows that donations to patient advocacy groups overshadowed the total amount the companies spent on federal lobbying in 2015; of the 14 companies that contributed $116 million to advocacy groups, the same companies reported only about $63 million in lobbying activities for the same time period.
Study Suggests That Two AEs May Predict Improved Outcomes With Bevacizumab
April 9th 2018A recent study concludes that both hypertension and proteinuria, which are considered to be interrelated with the pharmacological action of bevacizumab, have the potential to indicate greater likelihood of therapeutic efficacy.
FDA Releases 5-Year Financial Plan for Biosimilar User Fee Act
April 6th 2018The financial plan, which is revised each year, outlines the financial position of the Biosimilar User Fee Act program over the next 5-year authorization period, and explains how the FDA will allocate resources to build its biosimilars review program.
Samsung Bioepis Settles With AbbVie, Clearing Way for EU Launch of Adalimumab Biosimilar
April 5th 2018Samsung Bioepis and Biogen announced today that the companies have reached a settlement with AbbVie, maker of the top-selling Humira, that will allow the partnership to launch their approved biosimilar—Imraldi—in the European Union on October 16, 2018.