Systematic Review Identifies 6 Trends in US Biosimilar Approvals
November 30th 2017Because biosimilars are relatively new to the United States, drug makers pursuing FDA approval for biosimilars seek additional information about the kinds and quantities of evidence that the agency uses to approve these therapies.
SCOTUS Hears Case That Could End IPRs for Biosimilar Developers
November 29th 2017This week, the Supreme Court of the United States heard oral arguments in Oil States Energy Services, LLC v Greene’s Energy Group, LLC, a case that asks the court to decide whether inter partes review (IPR) is constitutional.
Biologics, and Costs, Are on the Rise in IBD Treatment, Study Finds
November 28th 2017Biologics are increasingly used in the treatment of inflammatory bowel disease (IBD), but real-world data quantifying the costs of these therapies have been lacking. A new study, published in Alimentary Pharmacology and Therapeutics, sought to determine trends in costs and relative market share of IBD therapies in the United States over the past 9 years.
Survey: Canadian Physicians Support Distinguishable Names for Biologics, Biosimilars
November 23rd 2017Results of a new national survey conducted by the Alliance for Safe Biologic Medicines (ASBM) shows that Canadian physicians support the use of distinguishable names for biologic therapies, including biosimilars,
Study: Record Number of Pharma Mergers Is Changing the Generics, Biosimilars Landscape
November 22nd 2017Low levels of competition among drug makers can lead to product shortages and increased generic drug prices, and a recently published study in Global Health suggests that mergers and acquisitions, which reduce the number of players in the pharmaceutical field, should be closely monitored by regulatory authorities.
ACR Praises CMS on Part D Proposals, Calls for Changes to APMs
November 22nd 2017The American College of Rheumatology (ACR) has voiced its approval of CMS’ attempts to lower the cost of drugs under Medicare Part D, but also called on the organization to allow more rheumatologists, including those in small practices, to take part in alternative payment models (APMs).
CMS Proposed Rule Would Treat Biosimilars as Generics for Cost-Sharing Purposes
November 17th 2017A new CMS proposed rule seeks to encourage the use of lower-cost biosimilars instead of reference biologics under Medicare Part D. The proposed rule would modify the definition of generic drugs—for the purposes of non–low-income-subsidy (LIS) catastrophic and LIS cost-sharing—to include biosimilar therapies.
Amgen v Apotex Upheld, Janssen v Samsung Bioepis Dropped
November 15th 2017The past week has seen the resolution of 2 high-profile biosimilar patent infringement cases. In the first, a district court’s ruling was upheld, and in the second, a reference drug sponsor agreed to drop its infringement claims—with prejudice—against a biosimilar developer.