Business

Opinion leaders discuss the significance of regulatory changes affecting biosimilar and insulin products.

Two Biogen officials make the case for getting anti–tumor necrosis factor (TNF) biosimilars into wider play.

Multiple contenders are lining up for the pending expiration of patents on the blockbuster Regeneron reference product for wet age-related macular degeneration.

Intract Pharma believes infliximab can be delivered orally and, in conjunction with Celltrion Group, aims to apply its technology and expertise to make it happen.

Samsung Biologics said it expects to invest over $2 billion in its new manufacturing plant and bio complex, for which construction will begin later this year.

Express Scripts, the country's largest pharmacy benefit manager, has reshuffled its preferred formulary list for 2021, giving preference to fewer pegfilgrastim products than in 2020.

The buck stops with the FDA when it comes to approving coronavirus disease 2019 therapeutics applications, said Anand Shah, MD, deputy commissioner for Medical and Scientific Affairs at the FDA.

Samsung Bioepis' latest approval gives it 5 biosimilar approvals in the European marketplace.

After receiving regulatory approval in June, Sandoz launched 2 of its biosimilars on the Canadian market.

US administrative and legislative efforts are moving the United States and Germany more into alignment on drug cost management philosophy, according to a review.

Employers could save thousands of dollars by promoting the use of biosimilars that will keep employees with rheumatoid arthritis from having to file for disability, according to Brian Gifford, PhD, research director of the Integrated Benefits Institute.

A Pacific Research Institute economist says that by his scorecard, biosimilars are not supercharging the market the way they ought to be doing .

There has been an outpouring of advocacy tugging biosimilars into the marketplace, and market share of these lower-cost drugs has increased.

Defining biosimilar use in the United States as "sluggish," Juliana Reed, MS, said employers have to get involved.

Dismayed at the low biosimilar uptake and the lost savings, large employers are taking matters into their own hands.

Opening the door to biosimilar competition starts with breaking down the patent barrier, says Christine Simmon, JD.

Now that Polpharma Biologics has fully integrated Bioceros into its brand, the company hopes to become one of the world’s leading biologics manufacturers.

United States Pharmacopeia (USP), the FDA, and others deliver constructive critique on how India can bolster quality in its biopharmaceutical industry.

Samsung Bioepis makes a move into the promising Brazilian market for biosimilars, which data suggest is one of the fastest-growing biosimilars markets among emerging nations.

With a sizable milestone payment from its partner Mylan, Revance has stepped up efforts to launch contenders in the Botox space.

Originator biologics should be monitored as closely as biosimilars, according to Gary Lyman, MD, MPH, of the Hutchinson Institute for Cancer Outcomes Research.

In an award-winning attempt to get closer to patients, Samsung Bioepis has replaced harsh typography with white backgrounds and gentle shapes on its new biosimilar packaging.

Teva Pharmaceutical Industries has expanded on its hopes for a biosimilar comeback with a commercialization deal with Alvotech, which could bring as many as 5 biosimilars to the US market.

Biosimilar exports make up a hefty chunk of biologics and other drug exports from the Republic of Korea to the United States and Europe, according to a report.

An oncology practice administrator describes the careful calculus involved in balancing patient needs with the business side of biosimilars and cancer care.

Although the pandemic continues to affect health care companies worldwide, biosimilar manufacturers continue to move forward with new product developments and business plans.

Vizient predicts that drug price inflation, partly due to the coronavirus disease 2019 (COVID-19), will be 3.29% in 2021 and is banking on biosimilars to help contain the rising cost of medication, it said in a comprehensive review for its member health companies.

Despite there being concerns over the safety of nonmedical switching between a reference product and a biosimilar, there is a growing body of evidence supporting the safety of switching, according to an executive of Sandoz, which produces biosimilars.

Shanghai Henlius Biotech has been given the green light to market its trastuzumab biosimilar (Zercepac, HLX02) in the European Union. Accord Healthcare will handle the distribution.