Biosimilar Accessibility, Expenditures Rising in Central, Eastern Europe
December 27th 2017Biosimilar drugs significantly influence the reimbursement systems of 10 Central and Eastern European countries, and the expenditure on the reimbursement of biosimilars (percentage of drug price covered by public payers) in those countries is increasing as biosimilars become more accessible to patients.
Dr Marcus Snow: 2017 Saw Increased Familiarity With Biosimilars, But Not Increased Uptake
December 26th 2017According to Marcus Snow, MD, assistant professor of internal medicine in the division of rheumatology, University of Nebraska Medical Center, some of the most critical developments in the biosimilars space during 2017 were the result of payer decisions.
Biologic Treatment in Patients With Axial Spondyloarthritis and Low Disease Activity
December 26th 2017A Polish study of axial spondyloarthritis patients who discontinued treatment with anti–tumor necrosis factor (anti-TNF) therapy because of low disease activity found that more than half eventually needed to restart anti-TNF therapy.
Study: Further Post-Marketing Research Warranted for Infliximab and Its Biosimilars
December 23rd 2017The European risk management plan (RMP) contains relevant safety information for specific products, with characterizations of both potential and identified risks, including real-world data. Because the RMP is systematically updated, the RMP can provide early indications of differences in product safety between originator and biosimilar therapies.
Study Address Financial, Clinical, Operational Concerns About Biosimilars
December 22nd 2017Biologics are the most expensive drug category in the United States. A recent study, published in the Journal of Managed Care and Specialty Pharmacy, investigated how American health systems are reacting to the introduction of biosimilars into the marketplace, and described real-world implementation strategies.
Report: Biosimilars Will Play Increasingly Important Role in US Biologic Market
December 22nd 2017Biologic drugs play a key role in the US healthcare market, as they are often the standard of care for treating complex diseases, many of which require long-term treatment. With the FDA’s approval of biosimilars of several important biologic treatments, and with a significant pipeline of biosimilars still in development, it is expected that many biosimilars will be introduced to the US market in the next several years.
JHL Biotech Submits Application for Phase 1 Trial of Proposed Dornase Alfa Biosimilar
December 21st 2017JHL Biotech, a biopharmaceutical startup based in Taiwan, announced yesterday that it has submitted a phase 1 clinical trial application to the Dutch Healthcare Authority for its proposed dornase alfa biosimilar, JHL1922, to improve pulmonary function in patients with cystic fibrosis.
Death in Phase 3 Study Dampens Positive Top-Line Data for Upadacitinib
December 21st 2017AbbVie reported on Wednesday that a phase 3 trial of its upadacitinib as monotherapy for rheumatoid arthritis (RA) met all of its primary and key secondary endpoints, giving more momentum to the drug that appears poised to help AbbVie retain its share of the RA market after adalimumab biosimilars launch in the United States. However, a death reported during the trial raises renewed concerns about the safety of the Janus kinase inhibitor.
Industry Group Spent Millions on Congress, Patient Orgs to Help Control Pricing Message
December 21st 2017Tax disclosure forms for 2016 show that the pharmaceutical industry’s biggest trade group, the Pharmaceutical Research and Manufacturers of America (PhRMA), raised revenue by almost one-fourth and spent the millions collected among hundreds of lobbyists, politicians, and patient groups—the largest income surge reported by the group since 2009, when it was mobilizing forces to advance the industry’s interests prior to the passage of the Affordable Care Act.
FDA Accepts BLA for Samsung Bioepis' Trastuzumab Biosimilar
December 20th 2017Republic of Korea-based Samsung Bioepis announced on Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB3, a proposed trastuzumab biosimilar, referenced on Herceptin. If the FDA approves SB3, the drug will be commercialized in the US by Merck.
Tax Reform Bill Largely a Plus for Big Pharma
December 20th 2017The tax reform bill proposed by Republicans and passed by the House this week contains benefits for many in the pharmaceutical industry. The reduction in the corporate tax rate from 35% to 21% will benefit all cash-flow-positive businesses, and the new, lower 15.5% rate for repatriating cash held overseas is likely to result in large companies becoming flush with cash, allowing them to buy back stock, increase shareholder returns, and fuel a wave of merger and acquisition (M&A) activity.
Fresenius Kabi Submits Adalimumab Biosimilar Marketing Application to EMA
December 19th 2017Fresenius Kabi, a subsidiary of the German-based Fresenius SE and Co. KFaA, announced yesterday that its Marketing Authorization Application for MSB11022, an adalimumab (Humira) biosimilar candidate, was submitted and accepted for review by the European Medicines Agency (EMA).
Mylan Announces IPR Proceedings Against Sanofi's Lantus Patents
December 19th 2017Mylan has announced that the US Patent Trial and Appeal Board (PTAB) has instituted inter partes review (IPR) proceedings on all claims against 2 patents that cover Sanofi’s innovator insulin glargine injection, Lantus.
The Journey of Biosimilar Epoetin Alfa Serves as Example of Approval Pathway Integrity
December 18th 2017Frank Dellanna, MD, and colleagues reviewed the journey of HX575 from development to approval in Europe, and describe a decade of clinical experience in patients with CKD, as the history and experience with this biosimilar provides an excellent example of a successful demonstration of biosimilarity.
Celltrion's Trastuzumab Biosimilar Gains Positive CHMP Opinion
December 18th 2017Republic of Korea-based biosimilar developer Celltrion announced on December 16 that it has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for its trastuzumab biosimilar, referenced on Roche’s blockbuster anticancer therapy, Herceptin. The positive opinion will now be referred to the European Commission for final review.
Adalimumab Effective in Treating Stricturing Crohn Disease
December 18th 2017While anti–tumor necrosis factor (anti-TNF) therapies are effective in helping patients with Crohn disease (CD) gain remission, data on using anti-TNFs in patients with stricturing CD are conflicting; some reports suggest that anti-TNF agents increase the risk of intestinal obstruction.
Eye on Pharma: Teva to Cut 14,000 Jobs in Major Restructuring Move
December 16th 2017Teva Pharmaceutical Industries, the world’s largest generic drug maker, based in Israel, unveiled its restructuring plan yesterday, which comes with big cuts to its research and development (R&D) department and staff.