May 6th 2024
Sarfaraz K. Niazi, PhD, explains FDA's new guidance on promotional labeling as well as challenges and insights into how this new guidance will impact biosimilars.
Report: The United States Could Save $54 Billion Through Biosimilars
October 25th 2017A new report by the RAND Corporation estimates the potential future cost savings gained from the use of biosimilars in the United States at $54 billion over 10 years, and examines future policy issues surrounding this important market.
European Union Launches Consultation on Patent Extension
October 19th 2017SPCs are an intellectual property right that grants an extension of up to 5 years on a 20-year patent term for an innovative pharmaceutical. The goal of the SPC is to offset the loss of patent protection that occurs during the development and clinical trials of a generic or biosimilar.
Report: Orphan Drugs Represent a Small Share of US Prescription Drug Spending
October 19th 2017While no one argues that orphan drugs that treat rare diseases can be expensive, the drugs’ reputation for being budget-busters is not borne out by a data presented in a recent report by Quintiles IMS Institute.
Judge Rules Restasis Patents Invalid, Also Questions Validity of Patent Transfer
October 18th 2017On Monday, a Federal Circuit judge invalidated Allergan’s patents for its dry-eye drug, Restasis, on the basis of obviousness. He also ordered the joinder of the Saint Regis Mohawk Tribe with Allergan as a co-plaintiff in the action against drug maker Teva, which seeks to develop a follow-on version of the drug.
Study: Injectable Anticancer Drugs Increase in Cost Regardless of Competition
October 17th 2017A study newly published in the Journal of Clinical Oncology found that, regardless of competition or additional approved indications, injectable anticancer drugs are subject to steady increases in price after launch.
HELP Committee Hears Industry Testimony on the High Cost of Drugs
October 17th 2017The Senate’s Health, Education, Labor and Pensions (HELP) Committee today heard testimony from pharmaceutical manufacturers and the supply chain in a full committee hearing titled “The Cost of Prescription Drugs: How the Drug Delivery System Affects What Patients Pay.”
Biosimilars Face Challenges From Providers, Patients, and Policies
October 13th 2017In recent paper published in Rheumatology, authors Till Uhlig, MD, and Guro L. Goll, PhD explore some of the remaining barriers to the adoption of biosimilar therapies in Europe. Physician attitudes, patient concerns, and prescribing restrictions on biologic therapies are all identified in the paper as having a role curbing uptake of biosimilars.
World Arthritis Day: Patients Benefit From Clinical Advances, Face Practical Challenges
October 12th 2017On this World Arthritis Day, patients with inflammatory diseases have increasing treatment options as biosimilars gain regulatory approval and become more widely available for use. New clinical data also help support the efficacy and safety of these therapies.
Funding Cuts for Navigator Programs Will Reduce Outreach, Services During ACA Enrollment
October 11th 2017Navigator programs, which provide outreach, education, and enrollment assistance to consumers eligible for health coverage through the Affordable Care Act marketplace and Medicaid, learned on August 31, 2017, about a 40% CMS spending cut on the program, with a wide disparity in funding cuts per state.
Judge Questions Whether Allergan's IPR Strategy Is a "Sham"
October 11th 2017Judge William C. Bryson has ordered Allergan to file a brief for a federal patent infringement case by Friday, October 13, after questioning whether the drug maker’s recent transfer of drug patents to a sovereign tribe was a “sham.”
Amgen Seeks Declaratory Judgment Against Genentech in Bevacizumab Suit
October 10th 2017Last week, Amgen filed a new lawsuit against Genentech in a California district court. The suit seeks a judgment that Amgen’s newly FDA-approved bevacizumab biosimilar, bevacizumab-awwb (Mvasi) has not infringed and will not infringe on 27 patents for Genentech’s reference bevacizumab treatment, Avastin.
UK Court Denies Pharma's Application for Judicial Review of Drug Price Policy
October 9th 2017UK trade group The Association of British Pharmaceutical Industry announced last week that the Administrative Court has denied its application for judicial review of a new National Health Service drug pricing policy.
EMA Reveals Its Relocation Wish List as European Commission Vote Nears
October 7th 2017After having warned that it could lose up to 94% of its staff in a relocation from its current home in London, United Kingdom, The European Medicines Agency (EMA) this week revealed its top location choices for the agency’s upcoming move.
European Study: Many Oncology Drugs May Not Extend or Improve Life
October 7th 2017A European study published this week finds that, at a minimum of 3.3 years after market entry, there was no conclusive evidence that many oncology drugs approved by the European Medicines Agency between 2009 and 2013 either extended or improved life in most oncology indications.
Outcomes-Guarantee Contracts May Help Align Drug Prices With Value
October 5th 2017Indication-based pricing is a method used to reimburse drug makers according to a drug’s indication-specific value when the drug has multiple indications. A number of healthcare payers have already implemented or are planning to implement IBP, including Express Scripts, the largest US pharmacy benefit manager.
FDA Announces 2 New Efforts Aimed at Drug Competition, Access
October 4th 2017In the first week of October, FDA Commissioner Scott Gottlieb, MD, announced 2 new initiatives intended to make drugs more widely available: the first is designed to help developers of complex generics better navigate the approvals process, and the second aims to streamline access to investigational treatments for compassionate use.
Allergan Faces Fresh Criticism and a New Lawsuit Over Restasis
October 3rd 2017Drug maker Shire has filed suit in a federal court in Newark, New Jersey, alleging that rival Allergan has violated antitrust laws in trying to preserve market share of its cyclosporine ophthalmic emulsion (Restasis) by blocking competition from Shire’s dry-eye drug, lifitegrast (Xiidra), on the Medicare Part D formulary.