News

Sarfaraz K. Niazi, PhD, discusses the regulatory approval of future messenger RNA (mRNA) vaccines, which will likely face fewer patent issues and are easy to replicate.

Here are the top 5 biosimilar articles for the week of July 26, 2021.

The approval of Biocon Biologics and Viatris' insulin glargine product as an interchangeable biosimilar will be a test of whether such designations can make a difference in patient access, Jeff Baldetti, MBA, of Cardinal Health explains.

After much anticipation, the FDA approves the first interchangeable biosimilar, which is hoped to bring down the high cost of insulin.

Pfizer reported strong sales for its biosimilars portfolio, but these were eclipsed by the massive success of the company's mRNA vaccine for COVID-19.

BioFactura looks to join the ustekinumab biosimilar race and Cardinal Health provides an interactive tool with state-by-state interchangeable rules.

Kashyap B. Patel, MD, says value of care is an important metric, but often people lose sight of what patients have to pay out of pocket, and how this affects them.

Biosimilar uptake could be more robust in the United States if the FDA can be convinced that biosimilars are worth the effort, according to Rep Kurt Schrader, D-Oregon.

Concomitant use of immunomodulators and dosage are important variables in the development of antidrug antibodies (ADAs) for patients receiving infliximab for Crohn disease, investigators report.

The Biologics Price Competition and Innovation Act (BPCIA) provides a stepwise approach for fact-finding prior to patent litigation, but companies may choose their own path, case examples show.

Biocon reports on its revenues from biosimilars and the FDA status of its insulin glargine product.

Here are the top 5 biosimilar articles for the week of July 19, 2021.

Without disclosing terms, Pfizer said it has settled with Johnson & Johnson (J&J) over a long-running dispute in which J&J was alleged to have blocked payers from covering Inflectra.

Shanghai Henlius Biotech initiates a trial for patients with macular degeneration while Dong-A ST and Meiji Seika Pharma agree on a distribution plan for a ustekinumab biosimilar candidate.

China has approved a product for rheumatoid arthritis and Crohn disease that Mabpharm and Sorrento Therapteutics say is an improvement on infliximab.

Pharmacokinetic, safety, and efficacy findings for patients with inflammatory bowel disease (IBD) were presented at the European Crohn's and Colitis Organization's annual meeting.

COVID-19 exposed a lot of holes in the public health safety net. An Amgen panel focused on ways to extend the reach of US medicine to make it more inclusive.

Samsung Bioepis launches a potential pivotal trial for its SB17 ustekinumab biosimilar candidate.

Amgen's advertising appeared to push doctors and patients away from the prefilled syringe version of its pegfilgrastim (Neulasta) product, which may have a better sales future than the Onpro.

On this week’s episode of Not So Different, we spoke with David Senior, senior vice president of Market Economics at AmerisourceBergen, about the development of the generics market and how this could be instructive in understanding how biosimilars sales may develop.

Real-world study in Italy finds most patients with inflammatory bowel disease (IBD) maintain clinical and biochemical response after switching from infliximab reference product to SB2.

Bio-Thera's BAT2206 ustekinumab candidate is in contention with multiple other proposed biosimilars to Janssen's Stelara.

Here are the top 5 biosimilar articles for the week of July 12, 2021.

An advertisement for the Onpro wearable pegfilgrastim injector kit has the potential to undermine sales of biosimilars, the FDA stated in a warning letter.

Panelists at the American Conference Institute's 2021 meeting took on the complexities of biosimilar adoption in a wide-ranging discussion.

Chad Landmon, JD, chair of Intellectual Property and FDA Practice at Axinn, Veltrop & Harkrider, provides a legal perspective on the implications of President Biden’s effort to improve the competitiveness of drug markets.

Presentations at the European Crohn's and Colitis Organization annual meeting supported the transition to adalimumab biosimilars and provided patient acceptance data.

Medicare lost out on over $2 billion in savings as adalimumab biosimilars were sidelined by patent restrictions, said investigators who recommended patent reforms.

Chong Kun Dang of the Republic of Korea has entered a licensing deal for the distribution of a darbepoetin alfa biosimilar in the Gulf region.

Biosimilars are launching at significant discounts to reference products and capturing increasing market share, according to an Amgen report.