Samantha DiGrande

September 29, 2018

The Initiative for Medicines, Access, and Knowledge (I-MAK) report notes that 89% of these applications were filed in the United States after Humira was already on the market, and 49% were filed after the first patent expired in 2014.

September 28, 2018

According to an unofficial estimate by the Congressional Budget Office, the Biosimilars Competition Act of 2018 will save about $100 million from 2019 to 2028.

September 27, 2018

Samsung Bioepis announced that the FDA has accepted a Biologics License application (BLA) for its adalimumab biosimilar, SB5, referencing Humira.

September 27, 2018

Advocates took to Capitol Hill last week to brief lawmakers and their staff about the implications the recent CMS policy change may have on patient access to treatments.

September 26, 2018

The European Union (EU) today authorized its second pegfilgrastim biosimilar, referenced on Neulasta. The product, to be sold as Pelgraz, is indicated to reduce the duration of neutropenia, as well as the incidence of febrile neutropenia for adult patients undergoing cytotoxic chemotherapy.

September 25, 2018

The National Health Service’s (NHS) Specialist Pharmacy Service released resources for clinicians to use with patients in the discussions around switching from the reference Humira to a biosimilar.

September 24, 2018

In its report, the Congressional Budget Office (CBO) notes that it “expects that the bill’s provisions would allow generic drugs (including biosimilar versions of biologics) to enter the market earlier, on average, than they would under current law.” Additionally, CBO said that enacting the legislation would reduce federal spending on prescription drugs.

September 22, 2018

Senator Dick Durbin, D-Illinois, a co-sponsor of the amendment, placed blame on pharmaceutical companies for using their influence to block the measure.

September 15, 2018

This week, Boehringer Ingelheim announced results from a 16-week phase 3 study that confirmed biosimilar adalimumab-adbm (to be sold as Cyltezo) was clinically equivalent to the reference product, Humira.

September 09, 2018

At a panel at the GRx+Biosims 2018, Molly Burich, MS, director of public policy for biosimilars and reimbursement at Boehringer Ingelheim, and Melissa Andel, MPP, vice president of health policy at Applied Policy, discussed the impact that US policy developments are having and will continue to have on the biosimilars market.