May 6th 2024
Sarfaraz K. Niazi, PhD, explains FDA's new guidance on promotional labeling as well as challenges and insights into how this new guidance will impact biosimilars.
COA Holds Emergency Hill Day to Warn Congress on Medicare Sequester
December 2nd 2017Yesterday, community oncology leaders flooded the Hill to meet with Congress and the administration to warn them of the impact the Medicare sequester’s increased cuts and extension will have on cancer care nationwide.
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.
Molly Burich: Biosimilar Regulation and Policy in the European Union and the United States
November 23rd 2017Molly Burich, MS, associate director of public policy: biosimilars, pipeline, and reimbursement at Boehringer Ingelheim, discusses major regulatory and policy differences between the European Union and the United States.
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,
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.
CMS Biosimilar Reimbursement Shift: What You Need to Know
November 16th 2017As part of the final CY2018 Medicare Physician Fee Schedule (PFS) policy, biosimilars will each have unique Healthcare Common Procedure Coding System (HCPCS) codes and payments under Medicare Part B, starting January 1, 2018.
South Centre Report Calls for "Biological Generics"
November 14th 2017The South Centre, an intragovernmental organization of developing nations headquartered in Geneva, Switzerland, has issued a new report on biosimilars that calls on regulatory bodies to institute an approval pathway for “biological generics” in favor of biosimilars.
Gottlieb Announces Draft REMS Guidance, Calls For End to "Shenanigans"
November 10th 2017During yesterday’s Federal Trade Commission public workshop on drug pricing competition, Scott Gottlieb, MD, Commissioner of the FDA, called on drug makers to “end the shenanigans” that delay drug competition in the US marketplace.
CMS Reverses Its Policy on Biosimilar Reimbursement, Will Issue Unique J-Codes
November 3rd 2017CMS has announced a change to its present policy on biosimilar reimbursement, stating that it will begin issuing unique Healthcare Common Procedure Coding System (HCPCS) codes to each individual biosimilar product.
Union Sues Johnson and Johnson Over Remicade
November 2nd 2017The United Food and Commercial Workers Local 1500 Welfare Fund has filed an antitrust lawsuit against Johnson and Johnson in Pennsylvania’s Eastern District Court. The suit takes aim at the drug maker over its blockbuster innovator infliximab, Remicade.