News

The agency will now review and act on original 351(k) biologics license application (BLA) supplements with clinical data within a 6-month time frame. Originally, such supplements had a 10-month goal date for review. In addition, applicants can now request the FDA refrain from taking action on supplements of 351(k) BLAs before a certain date.

The Center for Biosimilars® recaps the top stories for the week of February 3, 2020.

Bio-Thera Solutions announced that a phase 3 clinical trial comparing the efficacy and safety of its bevacizumab biosimilar, BAT1706, to the reference product (Avastin), returned positive top-line results.

Merck markets a biosimilar infliximab, Renflexis; a biosimilar trastuzumab, Ontruzant; and a biosimilar etanercept, Brenzys, in partnership with Samsung Bioepis.

Reference pricing may shift the mix of drugs dispensed from those offering the highest rebates to pharmacy benefit managers to those offering the lowest prices to employers and employees, according to a new study published Wednesday.

The FDA and the Federal Trade Commission (FTC) will work more closely to support a more competitive market for biosimilars and interchangeable products. In addition, the FDA published draft guidance for industry about how to advertise and promote biologic products truthfully and announced a public workshop.

In case you missed it: Jeffery Scott, MD, chief medical officer of Integra Connect, discussed what role biosimilars will play in a value-based system on a recent podcast episode of Not So Different.

The company has recalled its employees from Wuhan until the outbreak is brought under control, as have many other outside companies and government agencies with workers in the Chinese market affected by the coronavirus.

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended marketing authorization for Pfizer's Ruxience, a rituximab biosimilar.

In an effort to speed more generic drug approvals, the FDA said it is changing how it assigns priority review status to abbreviated new drug applications.

The Center for Biosimilars® recaps the top stories for the week of January 27, 2020.

The guidance document provides recommendations as to whether—and when—comparative clinical immunogenicity studies will be needed to support an application to the FDA for insulin products under the biosimilar approval pathway.

Researchers reviewed randomized controlled trials and real-world evidence studies on nonmedical switching; that is, switching patients who are doing well on their current originator therapy to a biosimilar.

The documents include specific ones for hemophilia, retinal disorders, and rare diseases, as well as manufacturing, testing, and patient follow-up.

A recently published commentary examines the global multiple sclerosis (MS) drug market from the perspective of patients and physicians, noting that different regulatory bodies have different standards in place for approvals, and questions if safety concerns are being addressed.

The study examined secukinumab biosimilar lentivirus-based gene therapy, which showed successful and prolonged expression of the recombinant antibody in rats.

The Center for Biosimilars® recaps the top stories for the week of January 20, 2020.

Pfizer said it expects its 3 oncology biosimilar products to have the lowest wholesale acquisition cost among currently available bevacizumab, rituximab, or trastuzumab biosimilars. Its latest, Ruxience, referencing Rituxan, launched Thursday.

Health New England says it achieved 93% utilization by requiring prior authorization.

Increasing trust in generics and biosimilars, and assuring their timely entry into the market, will yield greater benefit from these lower-cost options, according to a recent review.

In May 2019, the FDA released its final guidance on biosimilars. With more and more oncology biosimilars entering the market, healthcare providers should be able to help their patients reduce their out-of-pockets costs while providing the highest-quality care available, which will lead to savings over time, according to a recent column in Evidence-Based Oncology™, a sister publication to The American Journal of Managed Care®.

The Center for Biosimilars® recaps the top stories for the week of January 13, 2020.

The biosimilar CPT-13 (Remsima) is currently approved in Europe for all uses for which the originator infliximab (Remicade) is approved, including Crohn disease (CD) and ulcerative colitis (UC), which are often referred to collectively as IBD.

The current market value of the branded sales for these biosimilars is estimated to exceed $2 billion annually, the companies said.

An accompanying editorial describes the current regulatory process as “a thicket of special programs, flexible review criteria, and generous incentives,” and suggests starting points for reforms, including improving access to biosimilars.

In the United States, recent analyses show that biosimilars achieved just 9%, or $91 million, of the $1 billion in cost savings that the Congressional Budget Office projected 10 years ago.

The final report includes voting results from a December 2019 meeting of one of ICER’s independent evidence appraisal panels, the California Technology Assessment Forum (CTAF), plus policy recommendations from an expert roundtable.

The Center for Biosimilars® recaps the top stories for the week of January 6.

It is the only biosimilar candidate referencing Soliris to be granted investigational new drug approval in China.

It is the first adalimumab biosimilar approved by the China National Medical Products Administration.