News

Legislators on Capitol Hill are moving forward this month with bills that address patent issues pertaining to biosimilars.

According to the authors of a new study, while biologics are often believed to be more time consuming to develop than small-molecule drugs, development times are, in fact, similar between these 2 drug types.

A worldwide survey conducted by an international type 1 diabetes (T1D) advocacy non-profit found that rationing of insulin and related supplies was the greatest in the Unites States.

Biocon’s biologics facilities in Bengaluru, India, have received an EU certification of good manufacturing practice (GMP) after a March 2019 inspection, said the drug maker last week in a notice to the National Stock Exchange of India.

A Canadian advisory council is recommending the use of biosimilars in a final report that lays out 60 recommendations for how the country can create a C$15.3 billion universal, single-payer, public system for pharmaceutical coverage.

Irish hospitals will be offered a €500 (US $561) incentive for each patient switched from brand-name Humira or Enbrel to a biosimilar option.

Given the cost of the brand-name drug, there is interest among providers, particularly in contexts with limited resources, in using a biosimilar rituximab to treat pemphigus, and recently, 2 studies reported on the use of biosimilar rituximab in treating this disease.

Researchers say they were able to create an “antibody lock” that makes infliximab more selective in its activity, making it safer and more effective.

The Center for Biosimilars® recaps the top stories for the week of June 10, 2019.

Kanjinti was approved for the treatment of HER2-positive breast cancer and gastric cancer.

The introduction of infliximab for the treatment of inflammatory bowel diseases (IBD) did not result in lower population rates of hospitalizations or intestinal surgeries among patients living with IBD in Ontario, Canada, according to a study published Thursday.

Drug maker Genentech, developer of the brand-name rituximab, Rituxan, has announced that the FDA has accepted a supplemental Biologics License Application for the drug’s first proposed pediatric indication: 2 rare forms of vasculitis.

A new consensus paper from the Asia-Pacific Working Group on inflammatory bowel disease (IBD) released a set of best practices for improving IBD care with biologics and biosimilars.

The American Medical Association (AMA), which is holding its annual meeting this week in Chicago, Illinois, has issued a call for intensified oversight of the pharmacy benefit manager (PBM) industry.

“Do I think these numbers are reasonable and achievable? Potentially,” said Christina Corridon, MPH, MBA, a principal with the consulting firm ZS.

This month, a research letter appearing in JAMA Internal Medicine raises the questions of whether regulatory filings for new products are already made publicly available despite the FDA’s stance of treating these applications as confidential and whether there is room for increased transparency from the agency.

The 2 companies say that they will focus on biosimilars of originator products that will face patent expiry in 2025 to 2030.

A consensus statement developed by the Pan American League of Associations for Rheumatology (PANLAR) regarding biosimilars warned against the use of so-called "biomimics," or copy biologics.

“This systematic literature review found that the overall economic impact of biosimilar [nonmedical switching] remains uncertain,” write the investigators. More real-world studies will be necessary, they indicate, to quantify the full economic impact of nonmedical switches over the short and long term.

Insulin maker Sanofi is currently developing a proposed biosimilar of insulin aspart (NovoLog), made by Novo Nordisk. In 3 late-breaking poster presentations at the American Diabetes Association (ADA) 79th Scientific Sessions, held June 7-11, 2019, in San Francisco, California, researchers presented data on the biosimilar, SAR341402.

Pfenex and its partner Alvogen have submitted to the European Medicines Agency (EMA) a Marketing Authorization Application for PF708, which is a proposed biosimilar of teriparatide (Forteo), an osteoporosis drug.

A bill supported by a coalition of physician specialty organizations was introduced in the House of Representatives this week to alleviate the growing use of prior authorizations in Medicare Advantage. At the same time, the group released survey results saying that PAs are increasing physician burdens and leading to delays in patient care.

Early treatment with a biosimilar agent increased total costs by £70 (US $89) per patient versus standard intervention.

The Center for Biosimilars® recaps the top stories for the week of June 3, 2019.

Competition has done little to keep the lid on rising pharmaceutical prices for brand-name products, especially insulins and anti-inflammatory drugs, and costs will continue to rise unless action is taken, according to a recent paper written by researchers from the Scripps Research Translational Institute.

Generic drug maker Lannett Company has announced the beginning of a clinical trial of its proposed biosimilar insulin glargine referencing Lantus.

Last year, when noted researcher James Allison, PhD, won the Nobel Prize for Physiology or Medicine for his pioneering work that led to the development of groundbreaking oncology treatment, he took the occasion as an opportunity to decry what he said was a death of basic scientific research, as development for new pharmaceuticals is usually tied to closely guarded company data.

The United Kingdom’s National Health Service (NHS) has published a new document for clinical and nonclinical stakeholders about the role of biosimilars in the healthcare system. The guidance document, says the NHS, is intended to support the safe, effective, consistent use of biologics, including biosimilars, to the benefit of patients.

The FDA has issued a long-awaited and highly anticipated guidance on establishing analytical testing of biosimilars to a reference product This article summarizes the essential elements of the guidance, and it identifies pivotal changes and recommended study designs.

Ahead of the anticipated 2019 marketing of FDA-approved anticancer biosimilars in the United States, pharmacy benefit manager (PBM) Magellan Rx Management today announced the launch of an oncology biosimilar program.