News

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 Biologics Prescribers Collaborative released its comment letter to the FDA on the agency’s Considerations in Demonstrating Interchangeability, and made 5 key requests.

A recent study presented at EULAR found that a substantial number of patients who switched treatment from reference etanercept to a biosimilar switched back to the reference after a short period.

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.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has delivered a positive opinion Biogen’s adalimumab biosimilar, SB5 (also known as Imraldi), referencing Humira.

The Senate today revealed its long-anticipated healthcare reform bill, The Better Care Reconciliation Act of 2017. Like the House bill, the Senate legislation leaves some features of the ACA intact, including the BPCIA.

After negotiations with drug manufacturer Roche, England’s National Health Service (NHS) has approved the routine use of trastuzumab emtansine (Kadcyla) for the treatment of HER2-positive metastatic breast cancer in patients for whom trastuzumab (Herceptin) treatment has failed.

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.

Spanish researchers recently reported reliable detection of antibodies to infliximab (ATI) from venous or capillary blood using a rapid, point-of-care (POC) ATI test that allowed clinicians to detect ATI in a quick, decentralized mode that facilitated immediate POC decision making.

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.

Amgen announced Monday that the FDA has accepted its supplemental Biologics License Application for denosumab.

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.

In a recent study, researchers sought to investigate the clinical impact of 1-year certolizumab pegol therapy added to the first year of a 2-year treatment with methotrexate in patients with early rheumatoid arthritis.

Denmark is the first nation in Europe—and in the world—to switch all well-treated rheumatoid arthritis patients from reference infliximab (Remicade) to the biosimilar Remsima, and 1 early study suggests that the switch has been successful. Patients, however, have needed convincing.

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.

Lawmakers are contemplating a substantial range of reforms to make biologics more affordable for patients.

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.

Last week, Amgen and Allergan announced that the FDA will review data supporting the firms' Biologics License Application for ABP 215, a bevacizumab (Avastin) biosimilar candidate.

Coherus BioSciences announced that it has been issued a complete response letter by the FDA in response to its biologics license application for CHS-1701, a pegfilgrastim biosimilar candidate.

Two new reports of clinical switching studies in which patients undergoing treatment for rheumatoid arthritis (RA) were switched to a biosimilar version of the respective drugs provide some reassurance about the safety and efficacy of biosimilar products for infliximab (Remicade).

The Institute for Clinical and Economic Review (ICER) has issued a report recommending that dupilumab (Dupixent) offers good long-term value and important clinical benefit for patients with moderate-to-severe atopic dermatitis.

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.

On June 7, The Atlantic hosted a Policy Update on Biosimilars sponsored by The Biosimilars Council (Association for Accessible Medicines) as part of the publication’s “The Next Drug” series.