Business

Just 2 weeks after Coherus BioSciences announced that it had received a complete response letter (CRL) from the FDA in response to its biologics license application for a pegfilgrastim biosimilar candidate, the company has laid off 51 employees, or approximately 30% of its workforce, in a bid to cut its operating costs by $10 million.

Today, Sanofi and Regeneron announced that the European Commission has granted marketing authorization for the companies’ sarilumab (Kevzara), which is approved to treat severely active rheumatoid arthritis, and which outperformed Humira in a phase 3 trial.

Earlier this month, Biocad obtained a marketing authorization for its rituximab biosimilar in Bolivia and Honduras. The product, USMAL, will be available to patients within months. Yet the Russian firm sees roadblocks ahead for US market entry.

The FDA rejected, for a second time, Pfizer’s application for approval of its biosimilar epoetin alfa (Epoetin Hospira), a colony-stimulating factor indicated for anemia, biosimilar to Epogen and Procrit.

FDA Commissioner Scott Gottlieb, MD, has unveiled a new plan to facilitate increased competition in the prescription drug market through approval of more lower-cost, generic medications.

Worldwide prescription drug sales could reach $1.06 trillion by 2022, according to a new report. This earning represents only a 6.5% compound annual growth rate, and biosimilars may well play a significant role in curbed growth.

At the 8th Annual Summit on Biosimilars, a panel of legal experts reviewed lessons learned from the first 18 months of biosimilars in the United States, and looked ahead to the question of how these drugs will gain acceptance and market uptake.

Pharmaceutical manufacturers, pharmacy benefit managers, and various trade groups respond to the recent Supreme Court decision on the 6-month marketing rule post FDA approval for biosimilars.

Sandoz announced today that its biosimilar rituximab product has been approved by the European Commission to treat blood cancers and immunological diseases.

A viewpoint published in JAMA explains why biosimilar drugs approved in the United States for the treatment of chronic diseases may not result in expected cost savings.

A new survey of 47 healthcare C-suite executives found that drug spending has increased among healthcare leaders. That trend, the report’s authors say, will only increase in the coming years, and health system leaders will need strategies to cope with the burden.

Republican Nevada Governor Brian Sandoval yesterday signed into law the country’s strictest requirements for drug companies to show how they set prices for certain prescription drugs, with a specific focus on insulin.

States have taken the lead in advancing strategic policies and programs to attract, retain, and grow an innovative biopharmaceutical presence in the United States, according to a new report conducted for the Pharmaceutical Research and Manufacturers of America (PhRMA), which represents leading US biopharmaceutical research companies.

News of the landmark Supreme Court ruling in the case of Sandoz v Amgen broke during the Monday session of the 8th Annual Summit on Biosimilars, a meeting of legal and pharmaceutical industry professionals convened in New York City. In a previously scheduled—and swiftly updated—discussion of the case, a panel of attorneys grappled with the ruling and its implications for the industry.

On Wednesday, Boehringer Ingelheim announced results from a phase 3 trial of its adalimumab biosimilar candidate, BI 695501. The study’s results showed that BI 695501 and AbbVie’s branded adalimumab, Humira, have similar clinical efficacy, safety, and immunogenicity in patients with moderate to severe rheumatoid arthritis.

Joseph P. Fuhr, Jr, PhD, professor emeritus, Widener University, discusses the impact that biosimilars will have on the healthcare industry.

In a big win for Sandoz, the US Supreme Court ruled today that a manufacturer of a biosimilar product can provide a notice of commercial marketing either before or after FDA approval of the drug to the reference product developer.