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.
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."
EMA Could Lose a Majority of Its Staff in Post-Brexit Relocation
September 27th 2017The European Medicines Agency released results of an internal survey that asked staff to which proposed cities they would consider relocating. The lowest-ranking city was one to which only 6% of respondents were likely or very likely to relocate.
Healthcare Reform Efforts Turn to Drug Pricing
September 27th 2017Republican efforts to repeal and replace the Affordable Care Act may have stalled once again with the failure of the Graham-Cassidy bill on Thursday, but advocacy groups intend to keep healthcare—and the high cost of prescription drugs—at the forefront of Congress’ agenda.
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.
Stakeholders Urge Congress to Oppose Graham-Cassidy, Senator McCain Announces He Will Vote No
September 22nd 2017Ahead of next week’s proposed vote on Graham-Cassidy-Heller-Johnson, a Senate reconciliation bill that proposes to replace the Affordable Care Act with a system of state block grants given annually to help individuals pay for healthcare, insurers and providers groups are calling on Congress to reject the bill.
Pharma Groups Denied Restraining Order in Nevada Drug Pricing Lawsuit
September 22nd 2017Judge James C. Mahan of the US District Court denied the Pharmaceutical Research and Manufacturers of America (PhRMA) and Biotechnology Innovation Organization (BIO)’s motion for a temporary restraining order that would force Nevada to “cease and desist all action implementing or enforcing” contested sections of Nevada’s Senate Bill 539.
Drug Makers, Prescribers Urge CMS to Change Biosimilar Billing Policy
September 19th 2017Last week, CMS closed its comment period on the 2018 Revisions to Payment Policies under the Physician Fee Schedule. Multiple stakeholder groups within the biosimilars industry submitted comments to CMS with respect to its policy on biosimilar reimbursement.
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.
Global Experts Provide Consensus-Based Recommendations for Rheumatology Biosimilars
September 18th 2017In an effort to provide a guide for clinicians and a framework for future educational efforts, an international panel of healthcare stakeholders convened to arrive at consensus recommendations for the use of biosimilars to treat rheumatological diseases.
Pharma's Creative Strategies to Hold Off Generic, Biosimilar Competition
September 16th 2017Last week, Irish drug maker Allergan announced that it had transferred its patents for its cyclosporine ophthalmic emulsion, Restasis, to the Saint Regis Mohawk Tribe. Allergan said in a statement that the Tribe now owns all Orange Book-listed patents for the dry eye treatment, and that the Tribe is filing for a motion to dismiss an ongoing inter partes review on the basis of sovereign immunity.
Federal Perspective on the Biosimilar Influence on Drug Costs
September 14th 2017Providing an overview on where the healthcare reform debate is headed, Andrew Slavitt, former head of CMS, refined the discussion to highlight the potential for biosimilars to influence the rising costs of drug products.
US Department of Justice Files Amicus Brief in Amgen v Sandoz
September 14th 2017On Monday, the United States filed an amicus brief with the Federal Circuit in the case of Amgen v Sandoz. The brief addresses whether the Biologics Price Competition and Innovation Act (BPCIA) preempts additional remedies under state law for an applicant’s failure to comply with the so-called “patent dance.”
A European Perspective on Biosimilars
September 13th 2017At the 2017 AAM Biosimilars Council Conference, Adrian van den Hoven, director general of Medicines for Europe, contradicted the conventional thinking about biosimilars, saying that biosimilars do not simply reduce costs of treatment. Instead, he said, they deliver “huge additional health benefits to patients.”
AAM Executive: 1.2 Million Will Gain Treatment Access Because of Biosimilars
September 12th 2017Christine Simmon, senior vice president of policy and strategic alliances for the Association for Accessible Medicines (AAM) and executive director of The Biosimilars Council, told The Center for Biosimilars® at the 2017 AAM Biosimilars Council Conference that upcoming product approvals in the biosimilar space are exciting prospects not only for the industry, but, most importantly, for patients.
Coherus Fails in Challenge of Humira Patent, AbbVie Releases Phase 3 Results for New RA Drug
September 11th 2017Coherus BioSciences has announced that its petition for inter partes review of AbbVie’s US Patent 9,085,619, covering the formulation of adalimumab (Humira), was not instituted by the Patent Trial and Appeal Board.
State Insurance Commissioners and Governors Testify Before the Senate HELP Committee
September 8th 2017The US Senate’s Committee on Health, Education, Labor, and Pensions held the first 2 of its 4 full committee hearings on stabilizing the Affordable Care Act’s individual insurance market. Testifying on Wednesday and Thursday were state insurance commissioners and state governors, respectively. Across the 2 days of testimony, key themes emerged.