Kelly Davio

In 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.

President Donald Trump today signed an executive order on healthcare. The order will allow businesses to form associations that will have the ability to purchase health coverage from across state lines.

Judge 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.”

Last 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 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.

Cinfa Biotech has announced that the European Medicines Agency (EMA) has accepted for review the company’s marketing authorization application for biosimilar pegfilgrastim.

A phase 3 study comparing Samsung Bioepis’ etanercept biosimilar, SB4, to its reference found that SB4 had comparable efficacy—including radiographic progression—to week 52 of treatment in patients with rheumatoid arthritis.

In 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.

While tumor necrosis factor (TNF) deficiency is associated with a higher incidence of tuberculosis, excessive production of TNF is associated with an exaggerated inflammatory response that can result in mycobacterial immune reconstitution inflammatory syndrome (IRIS).

Medicines 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."

Drug maker Amgen has announced a deal to partner with Simcere Pharmaceutical Group to co-develop and commercialize 4 biosimilar treatments in China.

September was a busy month for oncology biosimilars: the first anticancer biosimilar was approved in the US, new data showed promising momentum for additional therapies, and patent litigation yielded costly results for one biosimilar developer.

Drug maker Amgen announced today that it has reached a global settlement with AbbVie, developer of reference adalimumab (Humira), over Amgen’s biosimilar adalimumab, Amgevita.

Republican 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.

Amgen has filed a news Biologics Price Competition and Innovation Act (BPCIA) suit against rival drug maker Mylan.

The 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.

At 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.

Scott 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.

Ahead 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.

A recent study found that enrollment in patient support programs was associated with greater adherence, improved persistence, and reduced medical and total healthcare costs for patients who were receiving adalimumab therapy.

Drug maker Pfizer announced today that it has filed a district court lawsuit in the Eastern District of Pennsylvania against Johnson and Johnson.

This 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.

Last 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.

In 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.

On Wendesday, Republican senators introduced HR 1628, a new effort to repeal and replace the Affordable Care Act.

On 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.”

At 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.”

On Tuesday, leaders of patient advocacy groups presenting at the 2017 AAM Biosimilars Council Conference had a clear message for industry: biosimilar uptake will only happen in earnest when patients begin to see savings on their out-of-pocket treatment costs.

Christine 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 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.