The Center for Biosimilars® recaps the top stories for the week of March 2, 2020.
Hi, I’m Christina Mattina for The Center for Biosimilars®, your resource for clinical, regulatory, business, and policy news in the rapidly changing world of biosimilars.
Here are the top 5 biosimilars articles for the week of March 2, 2020.
Number 5: The outcome of 3 major biosimilar antitrust actions, as well as a related Federal Trade Commission investigation, could significantly change how biologics are priced, writes attorney Ron Lanton III in a contributor piece.
Number 4: Investigators have determined that assays used to evaluate circulating drug levels and antibody resistance for the Remicade version of infliximab are also appropriate for 2 infliximab biosimilars, SB2 and CT-P13.
Number 3: Biocon received a letter from the FDA related to an inspection at its insulin manufacturing plant in Malaysia, where the company will produce its insulin glargine product, referencing Sanofi’s Lantus.
Number 2: The US Court of Appeals for the Third Circuit allowed Walgreens and Kroger to continue pursuing a lawsuit accusing Johnson & Johnson of unlawfully restricting access to biosimilar infliximab while pressuring healthcare providers and payers to use its higher-priced originator product, Remicade.
Number 1: A case report for a patient with lichen planopilaris revealed significant hair regrowth when originator adalimumab was added to the patient’s hydroxychloroquine regimen.
To read all of these articles and more, visit centerforbiosimilars.com.
Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
February 25th 2025The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
FDA, EMA Approve Second Pair of Denosumab Biosimilars
February 17th 2025The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' denosumab biosimilars, which will be marketed under different names depending on whether they will be used to treat osteoporosis or bone metastases.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
Biosimilars Fuel Price Cuts in European Insulin Glargine Markets
February 14th 2025Although Lantus continues to lead the insulin glargine market globally, the rise of biosimilars like Abasaglar and Semglee has sparked significant price reductions, with some European countries seeing discounts of up to 42.3%.