May 1st 2024
The FDA approved a high-concentration, citrate-free version of Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), making it the second high-concentration adalimumab biosimilar to have an interchangeability designation.
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.
Will Amazon Enter the Online Pharmacy Market?
October 9th 2017Amazon may be in the final phase of its decision to enter the online prescription drug sales market, according to analysts. Although Amazon has declined to comment, experts believe the company will decide before Thanksgiving whether it will enter the marketplace.
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.
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.
Eye on Pharma: Genentech Granted Priority Review for Pertuzumab Plus Trastuzumab
October 2nd 2017If Roche is successful in securing FDA approval, use of pertuzumab together with trastuzumab (also developed by Genentech's parent company, Roche) could help the drug maker hold on to some of its oncology market dominance in the face of growing competition from anticancer biosimilars.
New Report Addresses Medicine Shortages in the European Market
October 2nd 2017Medicines for Europe says that the sustainability of healthcare budgets in European nations has been “intensely pressured” in recent years by factors including an aging population and the introduction of high-cost drugs, and that governments aiming to address those challenges have resorted to austerity measures that have “driven the prices of some off-patent medicines to unsustainably low levels."
Hospira Ordered to Pay Amgen $70 Million Over Epoetin Alfa Patent Infringement
September 26th 2017Biosimilar developer Hospira has been ordered to pay Amgen $70 million after a jury found that the drug maker infringed on Amgen’s US Patent Number 5,856,298 (the ‘298 patent), which covers erythropoietin.
New Challenges for Johnson and Johnson: Biosimilars Erode Remicade Sales, Sirukumab Receives CRL
September 25th 2017The FDA has issued a complete response letter (CRL) for Johnson and Johnson’s proposed rheumatoid arthritis (RA) drug, sirukumab. Janssen Biotech, a division of Johnson and Johnson, had filed a Biologics License Application (BLA) for the interleukin-6 (IL-6) inhibitor, including data from a global phase 3 clinical development program, in September 2016.
Sandoz Releases New Clinical Study Data for Adalimumab Biosimilar
September 25th 2017At the 26th Congress of the European Academy of Dermatology and Venereology in Geneva, Switzerland, Sandoz announced positive data from a phase 3 confirmatory study to compare the efficacy and safety of Sandoz’s proposed biosimilar adalimumab, GP2017, with its reference.
Dr Scott Gottlieb Describes Biosimilar Challenges and Opportunities, FDA Releases New Guidance
September 23rd 2017Scott Gottlieb, MD, Commissioner of the FDA, has signaled that while biosimilars are on the rise, they need a boost from stakeholders if development of these therapies will continue to grow.
Rheumatology Expert Says Patients Should "Feel Comfortable" With Biosimilars
September 19th 2017This Rheumatic Disease Awareness Month, Stanley Cohen, MD, medical director of the Metroplex Clinical Research Center and clinical professor of internal medicine at the University of Texas Southwestern Medical School, has a message for patients: biosimilar treatments are just as safe and effective as originator biologics in treating rheumatic diseases.
Industry Groups Sue Nevada Over "Unprecedented" Drug Price Transparency Law
September 18th 2017This month, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO), trade groups representing the biopharmaceutical and biotechnology industries, announced that they are challenging Nevada’s Senate Bill (SB) 539 in district court litigation.