News

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.

The American College of Rheumatology has issued a response to CMS’ 2018 Physician Fee Schedule proposed rule, which was issued earlier this month.

A new survey assessing awareness of and attitudes about biosimilars among medical specialists and pharmacists in Ireland found that majority of such experts say that they are familiar or very familiar with the term “biosimilar,” but many general practitioners (GPs) were either unable to define or had never heard the term.

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

Merck today announced the US launch of its biosimilar infliximab, Renflexis, which it developed under a joint venture with Samsung Bioepis.

The Food and Drug Reauthorization Act of 2017, recently passed by the House, reauthorizes the Biosimilar User Fee Act (BsUFA). Learn about changes to the BsUFA in its new iteration, BsUFA II.

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 Center for Biosimilars recaps the top 5 stories in biosimilars news for the week of July 17, 2017.

An analysis of 53 switching studies reveals a variable level of good-quality evidence regarding switching from reference drugs to their biosimilars.

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.

Last week’s Oncologic Drugs Advisory Committee recommendation that the FDA approve 2 biosimilar treatments brought Swiss drug maker Roche a step closer to inevitable competition from biosimilar treatments.

The cost of developing copy versions of complex drugs—biosimilars and follow-ons for biologics and copies of nonbiological complex drugs such as nanomedicines, including drug-carrying liposomes—can be decreased, according to a new white paper.

The 2018 Medicare Physician Fee Schedule Proposed Rule, issued by CMS on July 13, considers changing a contentious billing code policy affecting biosimilar products.

Primary results from the ASSIST-FL Phase 3 clinical trial of GP2013, a proposed biosimilar of reference rituximab (Roche’s Rituxan, MabThera), showed that GP2013 is a viable rituximab biosimilar candidate for patients with previously untreated advanced follicular lymphoma.

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

On Monday night, Senators Mike Lee (R-Utah) and Jerry Moran (R-Kansas) announced their opposition to the Republican healthcare reform bill, the Better Care Reconciliation Act (BCRA).

A new report from GlobalData UK indicates that the market for HER2-positive breast cancer treatments could grow from $6.4 billion in 2015 to $9.89 billion in 2025, a compound annual growth rate (CAGR) of 4.4%.

A study published in the Journal of Clinical Pharmacy and Therapeutics found that SB5, a proposed biosimilar to AbbVie’s Humira, had pharmacokinetic (PK) equivalence to both European-sourced and US-sourced adalimumab.

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.

Celltrion Healthcare, the marketing subsidiary of Celltrion Inc, has secured approximately $886.3 million—well over a previously projected $713 million—in its July initial public offering of 24.6 million primary shares.

Recent studies show that some patients who initiate treatment with biosimilar etanercept switch back to reference etanercept or other biologics. View the infographic or read more about the study here.

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).

In its annual report, issued earlier this week, the Medicare program’s trustees said that Medicare will remain solvent until 2029, allowing the program to forestall triggering an Affordable Care Act provision to convene the Independent Payment Advisory Board.

The Center for Biosimilars recaps the top 5 stories in biosimilar news for the week of July 10, 2017.