News

AbbVie is engaged in new litigation over its blockbuster adalimumab (Humira). This week, the drug maker filed suit against Boehringer Ingelheim in a Delaware federal court, saying that BI will infringe on 74 of its patents for adalimumab in its development of a biosimilar product, BI 695501.

The development of biosimilars is focused on the minimization of potential differences between the proposed biosimilar and reference product, as well as the establishment of a robust manufacturing process to consistently produce a high-quality biosimilar.

The FDA’s Arthritis Advisory Committee (AAC) did not recommend the approval of Janssen Biotech’s sirukumab, a proposed monoclonal antibody for the treatment of moderate to severe rheumatoid arthritis, over concerns about mortality.

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of July 31, 2017.

The Senate today passed the FDA Reauthorization Act of 2017 (FDARA) in a roll call vote.

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.

A recently published study shows that Amgen’s ABP 501 (Amjevita), referenced on Humira, shows that the product has similar efficacy, safety, and immunogenicity to its reference in patients with moderate to severe rheumatoid arthritis.

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.

Coherus BioSciences has moved for a stay of discovery in BPCIA litigation concerning its proposed pegfilgrastim biosimilar, CHS-1701, referenced on Amgen’s blockbuster drug Neulasta.

Data from a recent study show that biosimilar filgrastim is readily used in France for the prophylaxis of chemotherapy-induced neutropenia. The data also demonstrate that clinicians’ assessment of febrile neutropenia risk is driven by patient factors more than by the European Organisation for the Research and Treatment of Cancer’s risk category of the chemotherapy regimen.

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.

An examination of national policies on biosimilars in 10 European Union member states concludes that supply-side policies targeting price can limit biosimilar penetration in the long term, while demand-side policies positively impact biosimilar uptake and are important drivers for biosimilar market penetration.

Amgen and Allergan announced today that the companies have submitted a Biologics License Application for ABP 980, a proposed trastuzumab (Herceptin) biosimilar.

How will the 35% price discount by Merck/Samsung Bioepis on their infliximab biosimilar, compared with the reference, influence stakeholder uptake?

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.

Biocon’s net profits for the past quarter dropped by 51%, according to a statement made by the Bangalore-based drug manufacturer.

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.

Biologic medications are an integral, crucial, and effective part of medical management for many life-threatening diseases and conditions, including cancer, but biosimilars are not without concerns.

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.

The emergence of biosimilar insulins may help broaden access to modern insulins, increase individualized treatment options, and reduce the cost of insulin therapy. Yet many healthcare providers may not understand the concept of biosimilarity and how biosimilar medications are similar, not identical, to their reference products.

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

The Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of July 24, 2017.

The potential immunogenicity of biosimilar agents is an important consideration in the treatment decision-making process, and a new systematic review of immunogenicity associated with biological therapies in chronic inflammatory diseases explores the frequency of immunogenicity and its potential impact on efficacy and safety.

FDA Commissioner, Scott Gottlieb, MD, testified before the House Judiciary Committee this afternoon in a hearing titled “Antitrust Concerns and the FDA Approval Process.”

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).

A new analysis of available data strongly confirms the equivalence of reference infliximab and CT-P13, and data are reassuring about the switching approach from the reference drug to biosimilar.

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.

A recent report prepared by the Analysis Group sought to describe the current pipeline of biopharmaceuticals under development that could benefit US-based patients within the next 5 to 10 years.

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

The prospective adalimumab biosimilar CinnoRA was shown in a recently published phase 3 trial to be comparable to AbbVie’s innovator biological treatment Humira in terms of safety and efficacy in adult patients with active rheumatoid arthritis.