Kelly Davio

Reimbursement remains a substantial concern in the market for biosimilar products, according to Amanda Forys, MBA, director of Xcenda’s Reimbursement Policy Insights consulting team.

Sanofi’s 2017 second-quarter sales from its diabetes and cardiovascular business declined by 15% relative to the same sales quarter last year, the French drug maker reported on Monday. Sanofi cited biosimilar competition in Europe as well as exclusion from US formularies as the chief reasons for its steep sales decline.

A recent survey shows that some patients have greater concerns about automatic substitution of biosimilar products than they do about the high cost of biologic drugs.

Celltrion and Teva announced today that the FDA has accepted for review the companies’ Biologics License Application (BLA) for CT-P6, a proposed trastuzumab (Herceptin) biosimilar.

The Senate may not consider the FDA Reauthorization Act (FDARA) until early September, after the congressional recess. The delay comes after Senator John McCain (R-Arizona) returned to the capitol to vote in favor of advancing a debate over healthcare reform.

July was a busy month for biosimilars targeting rheumatology indications; this month saw a product launch, developments in the legal realm, new clinical data, and prospective changes to Medicare reimbursement.

On Thursday, the Oncology Business Review (OBR) hosted a panel discussion, “The Advent of Biosimilars in Oncology: Planning Proactively for Change.”

Boehringer Ingelheim announced today that it has enrolled its first patient in a study to demonstrate interchangeability of its biosimilar adalimumab candidate, BI 695501, with the reference adalimumab (Humira).

This week, the House of Representatives passed the Medicare Part B Improvement Act, a bipartisan bill that, among other provisions, seeks to amend title XVIII of the Social Security Act in order to address the delivery of at-home infusion therapy.

While all eyes have been on the Senate, the House has been quietly preparing to address another key issue affecting healthcare.

Pfizer has announced positive top-line results from a comparative, confirmatory safety and efficacy study of an investigational bevacizumab biosimilar referenced on Avastin.

The American Society of Clinical Oncology (ASCO) has issued an official position statement addressing the affordability of cancer drugs. The position was guided, the organization says, by several key principles.

The FDA has granted Merck’s insulin glargine (Lusduna Nexvue) tentative approval. Merck says that its follow-on basal insulin has met all required regulatory standards of clinical and nonclinical safety, efficacy, and quality for follow-on biologics.

On Tuesday, the FDA held a public meeting titled “Administering the Hatch-Waxman Amendments: Ensuring a Balance Between Innovation and Access.”

A new report shows that most US-based health plans now cover at least 1 of the 2 FDA-approved biosimilars currently available in the marketplace.

The Association of the British Pharmaceutical Industry (ABPI) announced his week that it has applied for judicial review of a new budget impact test implemented by the National Institute for Health and Care Excellence (NICE).

Laboratorios Farmaceuticos ROVI (ROVI), a Spanish specialty healthcare company, reportedly expects to launch a biosimilar enoxaparin, a low-molecular-weight heparin (LMWH) product, in the European marketplace by the end of 2017. ROVI requested marketing authorization for its biosimilar product in Europe in 2014.

The FDA’s Oncologic Drugs Advisory Committee (ODAC) convened today to consider Biologics License Applications (BLAs) for 2 biosimilar products: ABP 215, Amgen’s bevacizumab biosimilar candidate (referenced on Avastin), and MYL-1401O, Mylan and Biocon’s biosimilar trastuzumab candidate (referenced on Herceptin).

On Wednesday, the US House of Representatives passed the FDA Reauthorization Act of 2017 (FDARA), which, among other provisions, reauthorizes user fees for biosimilar product applications. The bill, sponsored by Representative Greg Walden (R-Oregon), was passed by a voice vote.

Last week, the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) ruled to invalidate AbbVie’s patent on a method of treating rheumatoid arthritis using adalimumab (Humira). The PTAB deemed the claims in question unpattentable because of their obviousness.

Biosimilar rituximab, marketed in Argentina as Novex, is subject to an active pharmacovigilance program that, according to Argentine law, must periodically report its status and results to regulatory authorities. In a recent study, researchers examined pharmacovigilance reports to compare the safety profile of biosimilar rituximab with that of its reference.

France’s health regulatory body, the French National Agency for Medicines and Health Products Safety (ANSM), found that Biocon has failed to comply with good manufacturing practice requirements for 3 of its biosimilar products manufactured at the company’s Bommasandra facility in Bangalore, India.

The UK government sought to reassure citizens this week that “Brexit,” or the United Kingdom’s withdrawal from the European Union (EU)—and therefore its withdrawal from the European Medicines Agency (EMA)—would not negatively impact patient access to pharmaceuticals.

A bipartisan bill, introduced by US Senators Chris Coons (D-Delaware), Tom Cotton (R-Arkansas) Dick Durbin (D-Illinois), and Mazie Hirono (D-Hawaii), seeks to make a number of reforms that would make it easier for innovators—including the manufacturers of reference biologics—to defend against challenges to their patents.

To date, only limited data have been available concerning long-term clinical outcomes of switching patients with inflammatory bowel disease (IBD) from reference infliximab (Remicade) to a biosimilar treatment. A new study concludes that a switch to CT-P13 from reference infliximab was both safe and feasible.

The Biosimilar User Fee Act of 2012, which authorized the FDA to collect fees from biosimilar drug manufacturers to expedite their applications, is due to expire at the end of September.

The United Kingdom's National Institute for Health and Care Excellence (NICE), which provides value guidance to the National Health Service, has published its final appraisal determination for baricitinib (Olumiant), a Janus kinase inhibitor, recommending use of the drug as an option for treating severe active rheumatoid arthritis.

On June 28, Elaine Blais and Willy Jay, partners at Goodwin Proctor LLP, held a webinar discussing the Supreme Court’s Decision in the case of Sandoz v Amgen. While the court provided some much-needed clarity surrounding requirements of the Biologics Price Competition and Innovation Act “patent dance,” as Blais and Jay pointed out, the court’s ruling left a number of important questions unresolved.

Even as the industry awaited news of the Supreme Court’s ruling in the case of Sandoz v Amgen, many legal experts at the 8th Annual Summit on Biosimilars earlier this month were focused on inter partes review as an alternative to patent litigation under the contentious Biologics Price Competition and Innovation Act.

Sandoz announced today that is has received approval from the European Commission for its biosimilar etanercept (which will be marketed as Erelzi) for the treatment of multiple inflammatory diseases, including rheumatoid arthritis, axial spondyloarthritis, psoriasis, and psoriatic arthritis.