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Intellectual property law attorneys from the Washington, DC, offices of McDermott Will & Emery LLP, discuss 5 of the most significant trends in biologics litigation that have emerged in recent months.

Trade associations and companies in the biosimilars business ask the FDA to hone its proposed study on product disclosures.

This summer, The Center for Biosimilars® interviewed several experts for their opinions on the current need for biosimilars and how companies are working to overcome barriers to uptake. Here are some highlights.

Some European markets are more formidable than others with regard to complexity and getting biosimilars established, but there are good places to start, Jonathan Sweeting, head of Europe for Samsung Bioepis, explains.

It’s same old, same old when it comes to pharmacy benefit manager (PBM) contracts despite much touted reforms, authors of a review contend.

The Australia-based biosimilar company hopes to compete with blockbuster programmed death-1 (PD-1) inhibitor franchises owned by Merck and Bristol Myers Squibb.

The month of August was replete with clinical trial news and biosimilar launches for the treatment of rheumatic conditions.

For all intents and purposes, Semglee is a biosimilar insulin, but official biosimilar status is needed to clinch the marketing aspect.

With the launch of an adalimumab, Cadila hopes to get a piece of the worldwide biosimilar market for antirheumatic treatments.

To help employers achieve biosimilar savings, the Midwest Business Group on Health has created a 13-step action plan.

The Association for Accessible Medicines, which represents generic and biosimilar manufacturers, chose a leader with a research, public relations, and strategic planning background.

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.